Crossing the Border to Obtain Cheaper Prescription Drugs-Part V of a VII Part Article
(12/23/19)-The Department of Health and Human Services (HHS) released draft guidance that would enable certain medications made and sold in other countries including Canada, to be imported into the United States.
HHS Secretary Alex Azar in a news conference said the government aimed to make the importation of certain drugs available through a controlled supply chain, as opposed to allowing individuals to buy their own supply that they bring into this country. It presently is illegal to bring foreign produced drugs into this country
Mr. Azar said there would be a 75 day public comment period for the rule.. The imported drugs would have to be tested for their authenticity and safety, and be labeled for sale in the U. S. The drugs would also have to be FDA approved
Many of the injectable drugs and biogenetic drugs would be excluded from being imported
(6/21/16)- FedEx Corp. announced that the U.S. Justice Department has dismissed all remaining criminal charges against the company over shipments from online pharmacies. The government had accused the company in 2014 of ignoring government warnings from as far back as 2004 that it was shipping drugs from internet pharmacies that were not legally prescribed.
The company was also charged with conspiracy to distribute controlled substances. The company said it shipped more than 10 million packages a day and could not police everyone.
A majority of the charges against the company were dismissed in March.
United Parcel Service Inc. agreed to pay $40 million in 2013 to settle an investigation involving shipments from online pharmacies.
(10/11/13)- A Maine law that allows residents of the state to purchase prescription drugs from accredited pharmacies in Canada, the U.K., New Zealand and Australia has triggered a law suit in the U.S. District Court in Portland, challenging its legality. The law contravenes the banning of the importation of prescription drugs by consumers from foreign pharmacies by the Food and Drug Administration (FDA).
The suit was brought by the Pharmaceutical Research and Manufacturers of America (PhRMA), which is the lobbying arm of the pharmaceutical industry in the U.S. The ban is intended to protect the consumer from unsafe drugs made in foreign plants, even though the imported drug may have been manufactured in a facility that has been inspected and approved by an FDA inspector overseas.
In some cases the imported drug may even be a brand name drug sent to a foreign country, and now being re-imported to the U.S.
The question as to whether or not a state law can contravene the rules and regulations of a federal agency probably will ultimately end up in the lap of the Supreme Court of the U.S.
(5/28/12)- Even though the vote was 54-42, the Senate defeated a measure introduced by Senator John McCain (R.,Ariz) to allow Americans to buy prescription drugs from Canada.
After the measure was defeated Sen. McCain accused the lobbying arm of the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA) of using its influence to damage the interests of Americans. The measure required 60 affirmative votes in order to pass.
(8/26/11)- Peter Neronha, the head of the U.S. attorney's office for the District of Rhode Island announced that the federal government had agreed to settle its charge that Google had knowingly shown illegal ads for fraudulent Canadian pharmacies in the U.S. Google has agreed to pay $500 million to settle the charge that it was aware that some Canadian pharmacies had advertised on its site without having a prescription for substances like the painkiller Osycontin and the stimulant Ritalin.
The $500 million fine covers both revenues that Google earned from the illegal advertisers and revenues that the Canadian pharmacies received from American buyers of controlled drugs. The U.S. Justice Department office in the District of Rhode Island had led the investigation.
After Google became aware of the investigation, it has required that all Canadian pharmacy advertisers be certified by the Canadian International Pharmacy Association, and has specified that they can advertise only to Canadian customers. American pharmacy advertisers must be certified by the National Association of Boards of Pharmacy.
(5/3/10)- The May issue of the AAA's New York edition of Car & Travel contains a full page ad from a Canadian discount drug firm along with its toll free, 24 hours a day, 7 days a week 800 telephone number.
In the advertisement, the company displays a price for Lipitor in the USA and a much cheaper price for Lipitor that the company claims that it is selling the drug for.if you place an order with them over the phone.
To the best of our knowledge, it is still illegal to buy drugs in Canada, even for your own use, that will be imported into this country. You can not include the cost of drugs that you buy in another country, including Canada, in arriving at a total for your drug costs for Medicare Part D drug coverage purposes.
The ad and the phone number are there for you to check out and do with it whatever you choose to do.
(12/24/09)- The measure to legalize the importation of prescription drugs from Canada and some other countries failed in the Senate as part of the pending health care reform bill.
Senators voted 51-48 in favor of the amendment, but it required 60 votes in order to be adopted. A different amendment, supported by the drug industry that would have allowed the imports only with a safety clearance from the FDA, also failed by a 56-43 vote, with 60 votes being needed for passage of the amendment.
(12/12/09)- One of the planks of the Obama campaign platform called for the legalization of drugs to be imported from Canada. President Obama voted for the legalization of the importation of prescription drugs from Canada when he was the senator from Illinois.
Senator Byron L. Dorgan, Democrat of North Dakota is proposing legislation that would legalize the importation of drugs from Canada, but administration officials are now opposing this legislation.
The Dorgan proposal would blow apart an agreement a deal negotiated by the White House and the pharmaceutical industry in connection with the pending health-care reform legislation.The agreement between the president and the drug industry involved the pharmaceutical industry foregoing about $80 billion in profits that it would have earned if Medicare Part D cardholders would have to pay for drugs that they purchased in the "doughnut" hole at only half the usual price for the drug.
Senator John McCain, Republican of Arizona, a leading proponent of the legalization of drug importation, said, "There's a great dissension in the Democrat caucus over Senator Dorgan's amendment concerning the importation of drugs from Canada and other countries."
"If it passes, as it should, it breaks the agreement that the White House made with PhRMA (the drug industry's trade association), " Mr, McCain said
The Congressional Budget Office estimated that the Dorgan amendment would save the federal government $10.4 billion over the next 10 years.
Mr. Dorgan said, "My amendment includes strong safeguards to prohibit drug counterfeiting and other practices that would put the consumer at risk."
(11/7/07)- During a hearing being held by the House Energy and Commerce investigation subcommittee, which was chaired by Michigan Democratic Senator Bart Stupak, a report from the Government Accountability Office revealed that the FDA has inspection records for only about one-third of the foreign manufacturers that may be making drugs for the U.S. consumers.
The GAO found that the FDA "could not identify a previous inspection for 2,133 facilities out of 3,249" on a list that the agency used to set its inspection priorities. At its typical pace of 241 annual examinations, the agency would only check 7% of the manufacturers each year.
The FDA is supposed to inspect domestic drug makers every two years, but there is no such requirement for foreign suppliers. "More than nine years after we issued our last report on this topic, FDA's effectiveness in managing the foreign drug inspection program continues to be hindered by weakness in its data systems," Marcia Crosse, director of health care for the GAO said in a statement to the committee.
Other witnesses testified to the fact that the FDA gives foreign drug makers advance notice of inspections, in contrast to the unannounced inspections in the US. In many of the inspections, the FDA has to rely on foreign translators.
The seriousness of this problem comes to the forefront when the question of the importation of foreign drugs is brought up to help reduce the cost of drugs to Americans. It is one of the areas that must be improved on before you can allow the importation of these drugs. In looking at the Canadian situation, the facilities are approved of by the Canadian authorities, and are inspected by inspectors from states that want to legalize the importation of these drugs for its residents.
(5/11/07)- The Senate approved a measure containing renewal of FDA user fees and expanded regulatory powers for the agency. The proposal would also allow prescription drugs to be imported, but only if the secretary of health and human services first certifies that the imported drugs "pose no additional risk to the public's health and safety," and that they will significantly reduce costs to consumers.
This is the same provision that was introduced in both the Clinton and Bush administrations that in effect prevents the importation of these drugs, since the secretary of health and human services has refused to make such a certification.
The importation provision was sponsored by Senators Byron L. Dorgan, (D.-ND) and Olympia J. Snows, (R.-Me), but it was approved by a voice vote of 49-40 only after amending it to require the certifications of safety and savings.
Senator Edward M. Kennedy (D.-Mass) voted against the proposal and encouraged other senators to also vote against it because he feared that it would sink the overall bill granting new powers to the FDA. Senator Kennedy has also introduced legislation that would allow the importation of drugs from overseas.
Mr. Dorgan's proposal would allow consumers, pharmacist, drug wholesalers and distributors to import prescription drugs from Canada, Japan, Australia and European countries found to have regulatory requirements comparable to those in the US.
(10/5/06)- Lynn Hollinger, a U.S. Customs and Border Protection spokeswoman said that seizures of prescription drugs imported from Canada would cease on October 9. She did not offer any explanation as to what had caused the reversal of the seizure policy that began 11 months ago. "We're going back to operating procedures prior to November 2005."
As of mid-July, Customs had seized more than 37,000 prescription-drug packages from Canada. The spokeswoman did not reveal how many packages had been seized since July. Congressional pressure had been building against the seizures that last few months because of the complaints the congressional representatives were receiving from their constituencies.
Senator Bill Nelson, a Florida Democrat had requested that the Senate Committee on Homeland Security and Government Affairs investigate the new Customs policy.
House and Senate Republicans have agreed to a proposal that would allow Americans to bring back up to a 90-day supply of their medications from Canada. The proposal would however continue to make it illegal to buy medications online from Canadian pharmacies. The proposal did not deal with prescription drugs bought by mail from Canada.
It is difficult for us at therubins to understand the logic behind distinguishing between drugs that are bought at a Canadian pharmacy, and brought into this country by the purchaser, and the same drug bought online from the same pharmacy????
(7/30/06)- The U.S. Customs and Border Protection agency, in conjunction with the FDA began a more extensive seizure, inspection and confiscation program of drugs imported to this country from Canada on November 17, 2005. The seizure program has been able to expand because of the additional funding that the Customs people received as a result of the additional money that was allocated in the budget as part of the Homeland Security funding.
Although the importation of these drugs from Canada had always been deemed illegal, there was very little if any enforcement of this law until this recent change. The number or seized packages has now reached 37,154, which in turn has meant that Congressmen have been deluged with complaints from their constituency re these seizures. As we note in our item below dated 7/21/06 the Senate has approved a proposal to legitimatize the importation of drugs from Canada, but this proposal is a long way from being enacted.
According to IMS Health, a pharmaceutical-research firm, Canadian Internet pharmacies purchased $373 million of prescription drugs from wholesalers. Lynn Hollinger, a spokeswoman for the Customs-FDA seizure operation that took place in Miami, New York and Los Angeles asserted that a large percentage of drugs that were seized actually came from India, Costa Rica and Israel.
Please also keep in mind that the big U.S. drug companies continue to restrict the amount of their drugs that they are willing to sell to the Canadian wholesalers.
(7/21/06)- The U.S. Senate approved a proposal, by a vote of 68 to 32, that would legalize the importation of prescription drugs from Canada. The proposal was offered as part of a $31.7 billion spending budget for the Homeland Security Department in the fiscal year that begins October 1, 20006.
Senator David Vitter, a Louisiana Republican sponsored the proposal, but aides said that the proposal was likely to be removed when the legislation got to the conference committee of the House and Senate that will negotiate the final version
(4/18/06)- A combination of factors have occurred recently that are negatively impacting the Canadian online cross-border drug sales. The strength of the Canadian dollar in the last year, aggressive negative ads by our pharmaceutical companies about the safety of the Canadian drugs, and the effect of the new prescription drug law in this country have resulted in a sharp drop-off in sales for the Canadian online drug companies.
According to IMS Health, a pharmaceutical research group, sales of Canadian online monthly drugs to the U.S. have decreased from $43.5 million per month in early 2004 to $29.6 million in June 2005. At their peak in 2004, the Canadian online drug companies employed about 4,000 Canadians to about 3,000 presently.
David MacKay, a consultant to some Canadian online drug companies, and the former executive director of the Canadian International Pharmacy Association, estimated that the number of pharmacies licensed in Manitoba, the geographic heart of the industry, has declined to 32 this year, from 45 in 2005, and 70 in 2004.
(2/28/06)- The Canadian Pharmacy Association has reported that cross-border drug sales have fallen off by about 30% since the inception of the new prescription drug Medicare coverage law since January 1, 2006. The group attributed this fall-off to increased enforcement of the drug importation laws, as well as the new Medicare prescription drug law.
To try and counteract this fall-off the association will increase its marketing effort in the U.S.
According to the National Conference of State Legislatures the following states have set up Web sites that connect to certain approved Canadian sites for their residents to buy prescription drugs from Canada: Illinois, Kansas, Missouri, Vermont, Wisconsin, Minnesota, New Hampshire, North Dakota, Rhode Island, Washington and the District of Columbia. Nevada is in the process of launching a site for its residents shortly.
The Illinois Web site, I-SaveRx also serves residents of Kansas, Vermont and Wisconsin. The Minnesota site RxConnect links its residents to Canadian and British pharmacies.
(1/1/06)- The FDA conducted an inspection of packages ordered by U.S. consumers for a few days in August at John F. Kennedy Airport in New York, Miami International Airport and Los Angeles International Airport. The inspectors looked at packages that they suspected contained pharmaceuticals sent from India, Israel, Costa Rica and Vanuatu.
Packages were inspected from these four countries because these countries are sources of shipments for pharmaceuticals that were ordered by Americans from online Canadian pharmaceutical sites.
Out of the nearly 4,000 parcels examined, almost 1,700 packages or 43%contained drugs that had been ordered from Canadian online sites, and were represented as being of Canadian origin. 85% of the 1,700 packages inspected were drugs that were not manufactured in Canada, and came from 27 different countries.
The FDA said that in addition to having falsely promoted the drugs as being of Canadian origin, many of the drugs weren't adequately labeled in English to help assure safe and effective use. The agency also stated that 32 of the packages contained drugs that were counterfeited.
(10/11/05)-Louis Ling, general counsel for the Nevada State Board of Pharmacy, announced that the state's program that would allow its residents to purchase prescription drugs directly from Canada had been delayed until the state's attorney general issued an opinion as to the legality of the law. Nevada's attorney general is expected to announce his opinion by the end of the month.
The state's legislature passed and Governor Kenny Guinn signed the legislation allowing residents of Nevada to purchase drugs directly from Canada earlier this year.
(7/27/05)- The 5 states that have banded together to form the I-SaveRx prescription drug program announced plans to add Australia and New Zealand in addition to Canada, Britain and Ireland as sources from which their residents will be able to buy lower cost drugs. The five states participating in the program are Illinois and Wisconsin the founders of the program and Kansas, Missouri and Vermont who joined it later.
Abby Ottenhoff, a spokeswoman for Governor Rod R. Blagojevich of Illinois stated that the program worked only with licensed pharmacies in the exporting countries, and that those pharmacies must comply with Illinois standards. They can not dispense drugs that do not originate in one of these countries. According to officials from Mr. Blagojevich's office, the average prices for 78 common prescription drugs were 51% cheaper in Australia and 32% cheaper in Canada than the U.S. The I-SaveRx program began in October 2004, and has been used to place more than 10,000 prescription drug orders.
Please see our article dated 2/19/05 below.
(7/5/05)-"Canada can't be the drugstore for the U.S.," said Ujjal Desanjh, the Canadian health minister as he announced that the government would introduce legislation in September aimed at cutting back the exportation of bulk drugs to the U.S. The minister also stated that the government would draw up legislation aimed at eliminating the practice wherein the online Canadian drug companies provide doctor's to approve prescriptions written by U.S. doctors without having a face-to-face meeting with a Canadian doctors who approves the prescription.
According to the latest figures from IMS Health, a pharmaceutical information and consulting firm, Canada exported a total of $1.1 billion of drugs to the U.S. in 2004 which was up 10% from the prior year. The Canadian online drug industry employs about 5,000 people in that country. The restriction on the exportation of drugs in bulk is aimed at stopping the purchase of bulk drug by American cities and states, since it has the potential of causing shortages of medications in Canada. These purchases by the Americans are also serving to drive up the cost of the medication to the Canadian residents.
An estimated 2 million Americans buy their drugs through Canadian sources. There is an election expected to take place sometime in early 2006 in Canada, since Mr. Desanjh Liberal party is in the minority in the country. Republican Senator Olympia Snowe of Maine and Democratic Senator Byron Dorgan of North Dakota are co-sponsoring legislation that would allow imports of drugs from 25 nations as long as the drugs are manufactured in FDA inspected plants.
(6/24/05)- Governor Kenny Guinn, the Republican governor of Nevada signed legislation making it the 9th state, plus the District of Columbia, that will allow consumers in the state to legally import their drugs from Canada. Nevada will begin inspecting and licensing Canadian pharmacies, which will then be listed on a state run Web site.
Before he signed the legislation the Democratic State Assembly and the Republican State Senate passed the legislation in spite of assertions from the federal government that the law was illegal. Governor Guinn originally said he would not sign the legislation unless he could be assured it provided access to safe medications and did not violate federal law. A spokesman for the governor said amendments to the legislation has eased his concern over it.
(2/19/05)-The legislature for the state of Vermont has passed a bill authorizing the state to take part in the I-Save Rx program that was first put into effect last fall. Governor Jim Douglas said that he would sign the bill that allows residents of the state to buy prescription drugs from Canada. This would make Vermont the fifth state to participate in the program. The program was started in Illinois and now includes Wisconsin, Kansas and Missouri. The address for the site is s www.i-saverx.net.
Since the program started only 3,200 prescriptions have been processed by the plan. There are over 26 million people who are eligible to join the plan which has a network of 60 pharmacies in Canada, Britain and Ireland. It is estimated that Americans bought over $1.1 billion prescription drugs from Canadian pharmacies in 2004, according to IMS Health, a pharmaceutical information company.
One of the reasons given for the slow start in the program is the difficulty in enrolling in it. The enrollment process involves a 10-step process that requires patients to mail or fax a series of forms detailing their medical histories. After enrollment it takes another 20 days before the prescription is delivered
Vermont sued the Food and Drug Administration in August for rejecting a plan with a Canadian pharmacy in which residents of the state could receive mail order prescription drugs.
Westchester County in New York has added a Canadian mail-order option to its drug-discount card program, and the county is doing some extensive media advertising to try and promote the program
Senator Charles E. Grassley (Rep.-Io.) has agreed to co-sponsor a bipartisan bill in Congress that would allow the reimportation of prescription drugs from Canada by individuals, pharmacies and drug wholesalers. According to the senator, since the U.S. allows the importation of other goods from Canada, "Why not for pharmaceuticals?"
Canada accounts for about 3% of the retail prescription drug spending in 13 major markets followed by IMS Health. Out of a total federal budget of $2.3 trillion, the FDA budget is $1.46 billion in the federal fiscal year 2004-2005.
(1/05)-Two of the newly elected Republican senators have indicated that they favor a law that would allow Americans to re-import prescription drugs from Canada. They are Tom Coburn of Oklahoma and David Vitter of Louisiana. They replace senators who had opposed the re-importation of drugs from Canada.
(1/4/05)- Rhode Island became the first state to approve regulations that let its residents import prescription drugs from Canada. The new regulations become effective January 19, 2005. The state's legislature had approved a bill allowing the licensing of Canadian pharmacies. The State Health Department amended the rules recently, but the FDA has not acted yet on this matter, since the law conflicts with federal regulations.
The Rhode Island program would allow the importation of drugs from Canada as long as the pharmacy shipping the drugs was licensed by the state. Residents could order the drugs from a licensed pharmacy by the Internet, telephone or by regular mail. The licensing process for the Canadian pharmacies would be exactly the same process that the state uses to license any out-of-state pharmacy. The regulations also define minimum safety and staffing requirements.
Although the FDA has threatened to take legal action against cities and municipalities that have set up Web sites to help its residents import drugs from Canada it has not taken any legal action so far. Cities such as Springfield and Boston Mass. have bought drugs from Canada for their employees and retirees without incurring any legal action from the FDA.
A study conducted by a 13-member panel appointed by the Department of Health and Human Services reported that it was unfeasible to legalize the individual importation of drugs from Canada. Surgeon General Richard H. Carmona headed the panel that was created as a result of a requirement in the prescription drug law enacted in December 2004. The report went on to conclude that commercial importation by wholesalers and pharmacies, under strict regulation might be feasible.
Many Republicans as well as Democrats went public to criticize the findings of the report. Included in the group of Republicans criticizing the report were Senators Olympia J. Snowe of Maine, John McCain of Arizona and Trent Lott of Mississippi as well as Representative Jo Ann Emerson of Missouri.whose vote was critical in passage of the prescription drug bill in the House. Ms. Snowe said that the administration "failed to provide any meaningful recommendations" to Congress.
Commercial regulation of the importation of drugs from Canada would cost several hundreds of millions of dollars but is a doable according to the report. The report estimated that about "12 million prescription drug products with a value of approximately $700 million entered the U.S. from Canada in 2003." A similar amount of drugs comes into this country from all the other countries of the world.
The report went on to conclude, "If consumers were to buy generic products whenever possible and no brand name equivalents, we estimate savings to be approximately $17 billion" a year. Health and Human Services Secretary Tommy Thompson, who will be stepping down from that position shortly, said the administration might consider the legalization of certain high-volume brand name drugs from Canada, if the safety of these drugs could be insured.
The Bush administration declared that allowing the importation of drugs from overseas would harm the development of drugs in this country, since you would be limiting the income of the pharmaceutical companies by enacting such legislation. A separate Commerce Department study determined that prices in nine Western European countries, Japan and Canada were 18% to 67% cheaper than in the U.S.
(11/29/04)-One of the most frequently asked e-mail questions that we get here at therubins deals with the Canadian on-line drug industry. As a matter of fact we answered a query just this week that asked us about one of these Canadian companies. What follows is an edited copy of our response since it may be of some value to those of you looking to find a Canadian online pharmacy:
The Canadian drug industry is regulated by a governmental organization called Health Canada. To look up any Canadian online drug company go to the Health Canada site to see if there is any complaints against that particular company. The Canadian online drug industry has trade organization called Canadian International Pharmacy Association. Check with that organization to see if a particular company is a member or not.
We at therubins do not recommend any particular online drug company, but this article does mention that the state of Minnesota does have two online Canadian pharmacies that they recommend. They are www.canadapharmacy.com and www.crossborderpharmacy.com . Minnesota has had their health department go up to Canada to check out those two sites for safety before they put them on its approved list.
(11/19/04)-The European Union consists now of 25 different countries. A conflict has recently arisen there which is unnerving national health-care providers and insurers. Under one of the principles that govern the Union, services can have no national boundaries within the EU. Under another principle, the individual national governments deliver and organize health care for its own citizens. What happens if citizens of one country flock to another country and thus put an extraordinary burden on that country's health system? So far the European Court of Justice has sided with the individuals who have gone to another country within the Union, no matter how heavy a burden it may place on that country's health care provider budget.
In one of the presidential debates held in early November of this year President Bush was asked why he had blocked the importation of cheaper drugs from Canada responded by saying: "I haven't yet". He said his administration was carefully studying the issue to see if the government could somehow ensure the safety of the imported drugs. "It may very well be here in December you hear me say I think there's a safe way to do it," Mr. Bush said.
Among members of the Republican party who are in the forefront of allowing the importation of drugs from Canada are: Senators Olympia J. Snowe of Maine and John McCain of Arizona, Governors Tim Pawlenty of Minn., Craig Benson of NH and Representative Jo An Emerson of Missouri who voted for the Medicare Drug Act of December 2003 in return for the promise by the Republican leaders that they would allow an importation law to be considered by the Congress.
Under the new Medicare law, the secretary of health and human services is supposed to submit a report to Congress on drug imports by December 8, 2004. Dr. Richard H. Cremona is chairman of the Task Force on Drug Importation,k the group that is now studying the ability to ensure the safety of drug reimported from overseas.
(10/29/04)-Governor Gary Locke of Washington announced that his state would join with Illinois, Missouri and Wisconsin in their site which helps residents of those states order prescription drugs from Canadian pharmacies. Residents of Washington will be able to go onto a Web site set up by officials from Illinois that will enable them to compare the prices of prescription drugs in Washington with prices for those same drugs in Canada. The address for the site is www.i-saverx.net
Canadian pharmaceutical wholesalers and distributors are reporting shortages of some drugs because they are getting limited amounts of the drugs shipped to them by the U.S. brand name drug companies. As a result many citizens and residents of Canada are complaining to their elected officials about the shortages. The U.S. pharmaceutical companies say that they are merely restricting the shipments of Canada so as to maintain them at the same levels that were shipped to Canada last year.
(10/24/04)-One of the ironies of the flu vaccine shortage is how our government is now shopping around the world to obtain extra dosages of the flu vaccine. It in someways resembled what happened during the anthrax problem of a few years ago. When Cipro, the antidote for the anthrax was in short supply the U.S. government not only negotiated with foreign governments to get extra supplies of the drugs, but was also willing to negotiate with makers of generic versions of the drug in order to be able to get the needed amounts of the drug to the public. Compare this with the allegation that drugs imported from overseas are not "safe".
An article in the October 16, 2004 edition of the New York Times entitled "Importing Less Expensive Drugs Not Seen as Cure for U.S. Woes" endeavors to explain why the importation of drugs from Canada will not be a solution to the problem of high costs for drugs in this country. The article written by Eduardo Porter goes on to state: "It may make political sense to point to Canada as a solution to high prescription drug prices in the United States.
But many economists and health care experts say that importing drugs from countries that control their prices would do little to solve the problem of expensive drugs in the United States. Even the nonpartisan Congressional Budget Office estimated that allowing Canadian drug imports would have a 'negligible' impact on drug spending."
The article went on to quote Senator Byron Dorgan (Dem-Ndak.) in saying that price controls "wouldn't have a ghost of a chance to pass in Congress". Senator Dorgan is the main sponsor in Congress of legislation to allow the re-importation of drugs from overseas.
(10/11/04)- Governor Rod R. Blagojevich, the Democratic Governor of Illinois announced that the state and the state of Wisconsin had initiated a Web site for residents of the respective states that would enable the residents to buy 100 of the most common drugs used by Americans for chronic ailments. The drugs would be available at anywhere from a 25% to 50% discount from Canada, Britain and Ireland. The address for the site is www.i-saverx.net
The site has a letter from Governor Blagojevich on its title page wherein the governor states: "We are delighted to welcome the state of Wisconsin to I-SaveRx, as well, and hope that other states will join in this safe approach to saving money on prescriptions."
Illinois plans to contract with a Canadian PBM to create a clearinghouse of more than 35 approved pharmacies or wholesalers in Canada, the U.K. and Ireland. It is estimated that there are about 2.8 million residents of the state who have no prescription drug insurance coverage. Illinois will not allow nonresidents into the program and will waive co-payments for state employees and retirees when they use the import program.
Governor John Baldacci of Maine, a Democrat, announced that he was asking the federal government for permission to import drugs from Canada. Mr. Baldacci said that the state would designate the Penobscot Indian Nation as the wholesale distributor of the drugs. The Penobscot would build warehouses to store the drugs, and in turn sell them to pharmacies in Maine
The governor gave the Penobscots a $400,000 check to build a warehouse and set up a distribution program. Before proceeding any further with the program the state will wait for federal approval of the program. Until the approval is received, the Penobscots will start to distribute American drugs only, but hopefully at a much cheaper price than residents of Maine are paying. It is most unlikely that the federal government will grant the request. We at therubins also feel that there is no need to set up a new network to distribute these drugs when there is a drug distribution system already in place in this country.
Illinois,, Minnesota, New Hampshire, North Dakota and Wisconsin have set up Web sites with Canadian pharmacies so consumers can buy drugs on their own from Canada. Several U.S. cities have set up programs that import drugs directly from Canada for their municipal employees, retirees and their families , and or low income residents. These cities include Springfield, Mass.; Montgomery Ala.; and Burlington, VT.
Senator Byron L. Dorgan (Dem.-ND) said that the Democrats would introduce legislation in the Senate before it adjourns for the November elections to legalize the importation of drugs from overseas. He pointed out that when Dr. Mark B. McClellan was confirmed as the administrator for the Centers for Medicare and Medicaid Services, the Senator Bill Frist, the Tennessee Republican who is the majority leader promised on March 11, 2004 that "the Senate will begin a process for developing proposals that would allow for the safe re-importation of FDA approved prescription drugs.". Senator Dorgan has pointed out that so far that process has "led to nothing."
According to a study, based on cost data compiled by the U.S. Department of Health and Human Resources, from nearly 60,000 patients, found that 15 medical conditions accounted for half of the inflation adjusted growth in health care spending between 1987 and 2000. "Most of the growth in spending is among people who are very ill with chronic diseases that are expensive to treat," said Kenneth E. Thorpe, an economist at Emory University and lead author of the study.
The five illnesses where costs increased the most were heart disease, asthma, mental disorders, cancer and hypertension.
Vermont became the first state to sue the federal government for denying it permission to import prescription drugs from Canada. The state will sue the FDA for rejecting its plan for the importation of drugs from up north. Vermont officials had asked the FDA in November 2003 to approve a pilot program under which the state would contract with a Canadian company that would take orders from Vermont residents and distribute the drugs by mail.
The FDA rejected the application saying the government could not guarantee the safety of drugs imported from Canada. Governor Jim Douglas, a Republican said that he would ask the state's attorney general, William H. Sorrell to institute the suit. Minnesota, New Hampshire, North Dakota and Wisconsin have set up Web sites that link their residents to Canadian pharmacies that their agencies have inspected and approved.
Springfield, Mass., Montgomery, Ala. and Burlington, Vt. have already started programs that import drugs from Canada for their residents. About two dozen legislatures have passed or are considering passing legislation to allow such importation programs. An Illinois couple filed a federal lawsuit against the FDA and the secretary of Health and Human Services in February 2004 to allow the importation of prescription drugs from Canada.
The Vermont proposal initially allowed the state to import the drugs from Canada for current and retired state employees and their dependents, with a goal of expanding it to all residents of the state. Jason Gibbs, a spokesman for Governor Douglas said that Vermont officials would meet with New Hampshire officials to consider adopting New Hampshire's proposal to start importing Canadian drugs for some beneficiaries of state health care coverage.
Minnesota, which was the first state to set up its own Web site, estimated that it had 117,000 visitors to its site by the end of July. New York Attorney General Eliot Spitzer unveiled a new interactive Web site that would allow consumers to compare the prices for drugs at area pharmacies to get the best price. The address of the site is www.NYAGRx.com
Canadian online discount drug companies are rising to the challenge that has been extended to them when the U.S. pharmaceutical companies started to limit the amount of drugs that they would allow them to buy from their wholesalers, or even directly from the drug companies themselves. A handful of the Canadian companies are teaming up with foreign pharmacies that sell drugs for even cheaper prices than do the Canadian companies.
Australian and New Zealand pharmacies sell drugs for about 20% to 30% cheaper than do their Canadian counterparts. Prices in Chile and Israel are about 10% to 20% cheaper than it is in Canada. The Canadian pharmacies reselling these drugs from foreign sources won't reveal the names of the companies from whom they are receiving the drugs in order to protect them from being targeted by the U.S. pharmaceutical industry.
Although countries like Australia ban the exportation of its drugs, the government there has not acted against companies that are doing it. Pending talks at the world trade level are also taking aim at the exportation of drugs from foreign countries to the U.S. Americans have bought about $1.1 billion of Canadian drugs in 2003 according to IMS Health, a Fairfield, Ct. research firm. This was about double the amount that Americans purchased there in 2002. CIPA, the Canadian trade group estimates that about 2 million Americans have purchased their drugs in Canada since the trend began.
Bill Novelli, AARP's chief executive announced that his organization would throw its weight behind promoting passage of a drug importation bill that would allow people to legally import prescription drugs from Canada and other foreign countries. So far 23 legislators have announced that they would co-sponsor the drug bill that has been introduced in the Senate by Senators Byron Dorgan (D-N.D.) and Olympia Snowe (R-Me.).
Since there is only a short amount of time left in this session of Congress, Sen. John McCain (R-Ariz.), a supporter of the Dorgan-Snowe bill stated that lawmakers would try to attach it to another piece of legislation in the Senate. AARP will initiate a substantial advertising campaign in support of the bill and will also attempt to get more members of Congress to support it.
The Senate's Health, Education, Labor and Pensions Committee will consider another bill on this subject that was introduced by Senator Judd Gregg (R-NH), who is chairman of the committee. Senator McCain criticized this bill saying that it would allow the pharmaceutical companies to cut off supplies to foreign distributors without imposing any restrictions on this tactic.
This is exactly the tactic that the drug companies are using right now to restrict the supplies of drugs available to some of the Canadian distributors. The Dorgan-Snowe bill would make this practice by the drug makers illegal. The Dorgan-Snowe bill would require importers to register with the FDA and to submit their facilities to FDA regulations and inspections.
Dr. Steven K. Galson has been named Acting Director of the FDA's Center for Drug Evaluation and Research (CDER). Dr. Janet Woodcock has been moved over to a position within the Office of the Commissioner.
Governor Tim Pawlenty of Minnesota announced a program that would allow state employees and their dependents to buy, from an online website, prescription drugs from Canada. The site is the second of a two-phase plan that began earlier this year to help Minnesota citizens purchase safe and less expensive prescription medicines from Canadian pharmacies. State employees who use the site would be able to obtain some of their drugs with no out-of-pocket cost.
"For state employees, we're able to provide more than 45 prescription drugs at no cost to them," said Governor Tim Pawlenty. "By enabling state employees to have their prescriptions filled by Canadian pharmacies, we have the potential for significant savings for the State of Minnesota and our employees. This is an important step in our effort to reduce health care costs."
The program called Advantage Health Plan covers 120,000 eligible Minnesota state employees and their dependents. Minnesota is the first state in the nation and the largest public employer in the country to make this option available. The second website www.advantage-meds.com, was created to offer Advantage members a selection of prescription drugs more limited than that available to the general public on www.mnrxconnect.com.
The prescription drugs offered through this new web site are brand name maintenance drugs. The State spends $74 million per year on prescription medicines for employees. Maintenance drugs for high cholesterol, acid reflux, depression, diabetes, and arthritis alone accounted for $14 million of Advantage's pharmacy expenditures in 2003. Based on anticipated participation, the Advantage Plan is expected to save the State $1.4 million through 2005.
Advantage members are able to order through a secure website by providing some basic medical information and sending their prescription to the pharmacy. As required by law, the pharmacy must have a Canadian physician review the information and approve the prescription before filling the order. In addition, The State has entered into an agreement with the pharmacy to protect medical information and assure quality service.
Tommy Thompson, Secretary for Health and Human Services said that he would advise President Bush not to stand in the way of legislation that would allow the importation of drugs from Canada. "I think it is coming" he said. "I think that Congress is going to pass it." On the other hand Senate Majority Leader Bill Frist (R-Tenn.) said he does not know if the Senate will consider such a bill this year.
What with the summer fast approaching and Congress going into recess shortly the prospects for such legislation being enacted immediately looks dim. On the other hand, legislation that would allow the importation of drugs from other countries is one of the key issues that voters can show how important it is to them in the upcoming election. Many Congressmen realize this, so we may be able to see such legislation legalizing the importation of drugs sooner than some of the "experts" think.
A bipartisan group of senators announced that they would support a bill introduced in the Senate under the co-sponsorship of Senator Byron I. Dorgan, Democrat of North Dakota and Senator Olympia J. Snowe, Republican of Maine. The bill would legalize the importation of drugs from Canada and some other countries. Other senators who worked on this bill include Edward M. Kennedy, Democrat of Massachusetts; Trent Lott, Republican of Mississippi; and John McCain, Republican of Arizona.
The bill includes the following provisions:
The bill would give the government power to punish drug companies that hinder or thwart imports of prescription drugs. A manufacturer could not restrict the supply of drugs to a registered American importer. If a drug is manufactured overseas, the American manufacturer could not restrict the FDA inspectors from checking up on the plant if those drugs were to be legally imported into the U.S.
Health and Human Services Secretary Tommy Thompson recently said that the panel created under the new Medicare prescription drug law to study how drugs could be safely imported into the U.S. could issue its report as early as the end of the summer of 2004.
Senator Charles E. Grassley, Republican from Iowa, who is chairman of the Senate Finance Committee, introduced his own proposal on April 8, 2004. The Grassley bill would require foreign pharmacies and other exporters to submit compliance plans to the FDA and undergo inspection, financed by user fees levied on the exporters. Imports would be allowed first from Canada, followed by the legalization of imports from Australia and Europe.
Andy Troszok, president of the Canadian International Pharmacy Association, an industry group in Canada, said U.S. customers are being turned away or put on waiting lists for some of the most popular drugs used in the U.S. According to Mr. Troszok, the American drug manufacturers are "squeezing the vise tighter and tighter every month."
In July 2003 Springfield Mass. became the first U.S. city to buy Canadian prescription drugs for its municipal workers and retirees. Even though the FDA informed the mayor that the city was in violation of the law, Michael Albano, Springfield's mayor said: "I'm not going to stop. It's the right thing to do for my employees and my city." Of the 20,000 current employees and municipal retirees of Springfield about 3,000 current employees, retired workers and their families participate in the optional plan.
Chris Collins, the director of the program for Springfield announced that as of March 2004 the city had saved about $2 million under the program since it began in July 2003. The mayor continues to say that the city will continue with the optional program in spite of threatening letters from the FDA stating that the city was in violation of the federal law under its program.
Montgomery Alabama was the second major U.S. city to start such a program for its employees and retirees to try and lower the expenses that the municipalities were incurring.. The FDA has issued warning letters to three companies in Tempe, Tex., that the government claims is aiding Montgomery in its import program.
Mayor Thomas M. Menino of Boston told the City Council that he was planning a pilot program to buy Canadian drugs for current and retired city employees. Thus the city would be following in the footsteps of Springfield Mass., which became the first U.S. city to re-import drugs from Canada. Springfield's plan raised employee's co-payments for U.S. drugs, while charging them nothing for the same products from Canada. The Canadian drugs that the employees or retirees order are for drugs taken on a long time basis rather than drugs taken for emergencies. So far only 3,000 Springfield residents are involved in the program.
Governor Craig Benson Republican of New Hampshire has added a section on his official Web site linking to a state-approved Canadian mail-order pharmacy, Canadadrugs.com. His official site also tells about the state's plan to allow and encourage the importation of prescription drugs from Canada. Mr. Benson's Web site www.nh.gov./governor/prescription/prescription.html also answers some frequently asked questions about buying prescription drugs from Canada, and a cost savings analysis for the viewers to the site to use. Mr. Benson has also sought a waiver from the federal law that would make such importation illegal. A spokesman for the New Hampshire Pharmacists Association said that what the governor was doing was illegal.
Governor Benson also announced that he had ordered and received prescription medicine from a Canadian online pharmacy. He said that he had done it to check into the safety and procedures involved in ordering prescription drugs from Canada. He said that the medicine had cost about one-half of what it would have cost had he ordered the same medicine from the pharmacy benefit manager for the state municipal employees.
The FDA criticized his actions, writing to him, "We strongly believe that the endorsement by a public official such as yourself would undermine one of our nation's key consumer protection statutes."
In a preliminary ruling from the European High Court of Justice-the European Union's highest court-a drug trading company will be allowed to buy a drug for a cheaper price in southern Europe and resell it at a higher price in northern Europe. Strangely enough this case has interesting implications, none of which are binding in the U.S., in connection with the importation of drugs into this country from Canada.
The next step in the proceeding involves a German court's enforcement of the ruling. In this particular case Germany's medical agency denied the drug-trading company Kohlpharma the right to market a Parkinson's disease treatment drug, Jumex, that it had brought in from Italy. The German agency felt that it could not guarantee the safety of the drug that was being sold by Kohlpharma.
Kohlpharma pointed out that Germany was already allowing the sale of a similar product, Movergan that contained the same active ingredients as did its products. The company appealed the decision to the European court. This issue will continue to be a major one in the European Union. This is especially true what with the recent addition of 10 more countries to the Union. This opens up the door even further for cheaper drugs that are manufactured or made in these mainly eastern European countries to be resold for a higher price in the more westernized part of the Union. The European Federation of Pharmaceutical Industries and Associations, the industry's main trade group in Europe immediately denounced the decision.
PhRMA, the drug industry's trade group has hired former New York City Mayor Rudy Giuliani's consulting group to study the safety of imported drugs. According to Mr. Giuliani, and to Jeff Trewhitt, a spokesman for the trade group, the study will be entirely independent of outside influence. It is time we truly had an independent body study this issue, not a so-called "independent third party" paid by one of the groups involved in the issue.
According to the former mayor, the investigation will include examining drugs already seized by federal officials, and to see if modern technology can come up with techniques to ensure the safety of drugs brought in from other countries. This is an issue for our governmental agencies, not for the vested interests who are giving so-called "independent views".
The nomination of Dr. Mark B. McClellan, the former commissioner of the FDA, to become the administrator for the Centers for Medicare and Medicaid Services was confirmed by the Senate. The confirmation took place after Senator Byron L. Dorgan, Democrat of North Dakota, an advocate of drug imports from overseas lifted his "hold" on the nomination. Senator Dorgan lifted his hold after extracting a promise from Senate majority leader Bill Frist, Republican from Tennessee, to help develop legislation to allow imports of drugs from overseas.
Dr. Frist declared, "The Senate will begin a process for developing proposals that would allow for the safe re-importation of FDA-approved prescription drugs." At the same time Dr. Frist did not promise "a vote on a date certain" for the legislation. The CMS provides health benefits to more than 70 million people who are elderly, disabled or have low incomes.
Supporters of legislation to re-import prescription drugs from overseas gained another significant supporter when Senator Trent Lott, the former Republican majority leader said he would back legislation to legalize the re-importation of these drugs from overseas. Last year the House passed legislation that would have allowed U.S. pharmacies, wholesalers and individuals to import prescription drugs from 25 countries, but this provision was not included in the bill that was eventually passed. Senator Dorgan has introduced a bill in the Senate that mirrors this House version of a drug re-mportation law.
Senate Finance Committee Chairman Charles Grassley (Rep.-Io.) and Senator Edward Kennedy (Dem.-Mass.) are presently working on legislation that would legalize the re-importation of drugs from overseas. Republican Senator John McCain of Arizona has also called upon the administration to come forth with legislation that would legalize the re-importation of drugs from overseas.
According to IMS Health, a pharmacy industry research firm, Americans spent $695 million last year for drugs that they bought either in Canada or over the Web through Canada. This compares with the $414 million that Americans bought in Canada in 2002. Incidentally, Health Canada, the country' health regulator, sets the price for drugs in Canada partly by averaging the prices charged in the Group of 8 industrialized countries for any given drug.
The new Medicare drug prescription law that was enacted and signed on December 8, 2003 provided for the creation of a committee to study the issue of importation of drugs from Canada. In enacting the law, Congress instructed the administration to study whether drugs could be safely imported from Canada if the government hired more inspectors, if all shipments were routed through specified ports, and if the drugs carried electronic tags so that they could be traced throughout the supply chain.
The Bush administration announced that the committee would be formed and headed by Mark B. McClellan, the former commissioner of the FDA, who will now become the head of the CMS. This has led to a large outcry by proponents for allowing the importation of these drugs from Canada, since Dr. McClellan has been in the forefront of the opposition to allowing this importation. The new committee will study the issue for a year before making a report on its findings.
Senator Byron L. Dorgan, Democrat of North Dakota, said: "It's like putting the fox in charge of the chicken house." A spokesman for Senator John McCain, Republican of Arizona said that he believed the administration should have chosen "a more objective person."
The Minnesota Human Services Commissioner Kevin Goodno said that officials from his agency and also representatives from the Minnesota Board of Pharmacy visited pharmacies in Canada in December before selecting the two that are tied in with the site. The two Canadian Web sites that have been selected by Minnesota are the Vancouver-based Granville Pharmacy (www.canadapharmacy.com ) and the Calgary-based Total Care Pharmacy (www.crossborderpharmacy.com )
As a follow-up to approving the 2 Canadian pharmacies the state's Department of Human Services sent inspectors up to Canada to check on 8 other Canadian mail-order pharmacies. The report back from the inspectors showed a wide variation in the proper controls among the 8 pharmacies. The state's finding is contained in a 20-page report that covered the whole gamut of safety issues. Many safety issues were raised in several of the pharmacies that were inspected.
Among the serious issues that were uncovered were included one pharmacy that did not use child safety-caps on any of its medications. Others had tecnicians working without direct supervision by a licensed pharmacist. "The message that we took away is that not all pharmacies are the same," said Kevin Goodno, Minnesota's commissioner of human services. He went on to say that in some cases the FDA is correct in pointing to the safety problem, while in other cases "the FDA concerns are overstated." Andy Troszok, vice president of the Canadian International Pharmacy Association urged the FDA to come to Canada and make similar type inspections as was done by the Minnesota Human Service Commission. In doing so it could find out which of the Canadian pharmacies could be safely used in connection with the importation of drugs into the U. S. from Canada.
A spokesman for the state of Illinois, under Governor Rod R. Blagojevich, a Democrat, said he had encouraged a couple to sue, and had helped them find an attorney in connection with the issue of drug importation from Canada. The lawyer, Robert A. Clifford, said the plaintiffs, Ray and Gayleee Andrews, both 74, spent between $800 to $1000 a month on prescription drugs. The state is not a party to the suit, but will file a brief in support of the position of allowing the importation of drugs from Canada.
Pfizer, Inc. said that it had cut off several Canadian Internet pharmacies for exporting its drugs in violation of the previous warning letter they received which cautioned them against doing this type of business. Pfizer would not say how many companies received the letter dated February 12, 2004, stating they had violated business agreements by either selling drugs to individuals outside Canada, or selling to others who exported the drugs themselves.
Governor Tim Pawlenty of Minnesota and Governor James E. Doyle of Wisconsin said that they would ask the governors of the other states to join them in screening online drug stores in Canada at the meeting of governors that is scheduled to convene this week in Washington. Wisconsin plans to have a Web site of its own in operation shortly to make it easier for residents of the state to be able to buy prescription drugs from Canada. It thus becomes the second state to have such a site.
According to Helene Nelson, Wisconsin's secretary of health and family services, the state is presently inspecting the online drug companies in Canada for safety qualifications. Andy Troszok, a vice president at Total Care Pharmacy of Calgary, one of the online drugstores recommended by Minnesota, said that over the last two years the pharmacies in Canada had proposed that the FDA do its own inspecting of the drug companies up north. Ms. Nelson, the Wisconsin health secretary suggested that the states could use a service such as the Internet Mail-order Pharmacy Accreditation Commission to check on the record of the online drug companies in Canada. This commission was set up in Manchester, Vt. to measure an online pharmacy's performance against 92 criteria. The fee for the check is $21, 000.
Governor Tim Pawlenty unveiled a drug site to assist Minnesota residents in buying maintenance prescription drugs from Canada. The state believes that this is the first officially sponsored state site set up for this purpose. The address for the site is MinnesotaRxConnection.com. For those who do not have on-line capability the telephone no. is 1-800-333-2433. If you use the phone specialists from MinnesotaRxConnection will be able to send you the appropriate forms, including safety info and other information that is found on the site.
The government has conducted a second test of inspections by federal drug and custom officials of medicines imported from Canada. These inspections are part of a growing concerted effort by the Bush administration to stop pharmaceutical drug imports from Canada. Thus the drug companies and the government are headed for a collision with the growing movement to import medications from Canada because of the cheaper price for the Canadian drugs. In this latest inspection case, almost 2,000 packages were opened and found to contain foreign versions of American pharmaceuticals that the officials claimed might not be "safe".
Advocates of the importation program point out the fact that the FDA has yet to identify a single patient harmed by such importation of drugs from Canada. Health Canada, which regulates the pharmaceuticals in that country are just as rigorous in enforcing safety regulations for its drugs as is the FDA in this country.
"This has little to do with health and safety and everything to do with the pharmaceutical industry," said Peter A. Clavelle, mayor of Burlington Vt., who said he intended to have a Canadian drug purchase program up and running for city employees and their families by March 1, 2004. A group of governors has indicated that they will meet in Washington after the National Governors Conference in February to discuss the drug importation situation.
In a letter dated January 12, 2004, Pfizer Inc. has placed new and added restrictions on Canadian retailer pharmacies who deal with its wholesalers. Authorization to continue to deal with Pfizer is conditioned, among other things, on a promise not to ship drugs to U.S. customers. The letter contained demands broader than an earlier advisory to 46 Canadian pharmacies to buy directly from the U.S. company, instead of through wholesalers, and demanded that they not ship the drugs back into the U.S. Last month, Pfizer told its distributors that hey must seek approval to sell to any new pharmacy or any pharmacy whose purchases exceeded certain amounts.
Peter Wyckoff, executive director of the Minnesota Senior Federation metropolitan division in St. Louis said that they have not as yet seen a decline in the number of drugs being exported by the Canadian internet drug companies. The federation, a nonprofit advocacy group for older people has signed up about 4,500 so far in 50 states.
The Canadian Medical Protective Association, a self-insurance group that provides legal assistance to about 95% of the Canadian physicians facing malpractice suits, said it won't help Canadian doctors who are involved in lawsuits over their countersigning of prescriptions from U.S. patients. Canadian law allows the exportation of Canadian drugs if a Canadian physician countersigns them. A spokesman for the association said it hopes to remove this bar if the Canadian government drops the countersigning restriction.
The Canadian International Pharmacy Association, which represents the Canadian based online drug retailers, held a teleconference with New York State's Attorney General Elliot Spitzer. The purpose of the teleconference was to attempt to get his support in prosecuting the claim that the pharmaceutical companies were illegally conspiring to restrict the shipment of drugs to Canada. In restricting their shipments of their drugs to Canada, the drug companies were in effect illegally conspiring to eliminate pricing competition from the Canadian Internet drug retailers.
During the meeting the parties discussed the issue of large pharmaceutical companies such as Johnson & Johnson and Pfizer Inc. warning their wholesalers to only buy its brand-name drugs from approved wholesalers or risk being cut off from being supplied with the drugs. Another topic discussed was Minnesota's accusation that GlaxoSmithKline PLC was conspiring with other companies to keep cheaper drugs from being re-imported from Canada.
The Canadian International Pharmacy Association, which represents 27 Canadian online pharmacies, said its members won't provide drugs for U.S. state, municipal or large retiree programs because of the large demand that this creates for the Canadian drugs which in turn could create a shortage of these drugs for Canadian residents.
The announcement went on to state that the short supply could occur because of restrictions being placed on the Canadian pharmacies by the U.S. brand name drug companies. Canadian health officials have stated that so far there is no shortage of drugs in Canada, although they are watching the situation closely. Health Canada, the counterpart to the U.S. Food and Drug Administration has agreed to share information with the U.S. officials about online pharmacies suspected of shipping unsafe products.
Pfizer Inc. notified its wholesalers and distributors that they must buy the company's medicines only from Pfizer or authorized resellers, or be cut off as customers. This move is similar to the one instituted by Johnson & Johnson a few weeks ago in an attempt to "limit counterfeiters and illegal importers" of their drugs. In reality the move is also intended to try and restrict the importation to this country of drugs from overseas.
The pharmaceutical companies sell the vast majority of drugs to wholesalers, who in turn sell it to their large customers and pharmacies. Sometimes spot shortages develop and wholesalers or distributors might than sell some drugs among themselves. This is the channel that most counterfeiters use to make their sales of their products.
Pfizer also said that it intended to post the names of participating wholesalers and distributors on is Web site early in 2004, so that customers can choose to buy from middlemen in compliance with the company's policies. Johnson & Johnson and Eli Lilly & Co. will allow middlemen to buy medicines only from the original manufacturer. Thus in effect the drug companies are limiting the re-importation of their pharmaceuticals from abroad.
Governor Craig Benson of New Hampshire announced that the state would begin to buy medicines from Canada for prison inmates and Medicaid recipients taking drugs for mental illnesses. The drugs purchased would be those that were made in the U.S. and sold in Canada, but "re-imported" to the U.S. Governor Benson also plans to set up a Web site for residents of New Hampshire to buy drugs from Canadian Internet companies with restrictions.
New Hampshire buyers would have to have prescriptions signed by Americans physicians and approved by Canadian physicians. The medications that would be re-imported to the state would have to be in their original packages. The governor said that he would proceed with these plans even in the face of objections to its legality by the U.S. Justice Department.
In West Virginia officials are exploring plans to import drugs through local pharmacies rather than by mail order. The state would allow its pharmacy benefits managers to import the drugs from Canadian pharmacies that have been approved by the state in conjunction with the Canadian government.
The FDA has previously sought to crack down on companies that serve as intermediaries between the sale of Canadian drugs to U.S. customers. This was shown to be the case when the agency sent a letter to Rx Depot Inc. of Tulsa, Okla. that we mention later in this article. So far the FDA has not pursued the individual purchaser of the drugs rather than the supplier.
The governors of four states have now come out in favor of having some sort of program in their state so that municipal employees and retirees, and seniors can import drugs from Canada. These states are Illinois, Iowa, Minnesota and Michigan. In the state of Kentucky, the state's attorney-general Ben Chandler who ran for the governor of the state has come out in favor of having some sort of program that would enable the residents of the state to import drugs from Canada.
In the November elections in Kentucky the Republican representative from the state Ernie Fletcher opposed Mr. Chandler for the position. Mr. Chandler continued to point out during the election that Representative Fletcher voted in Congress against legalizing drug imports from Canada. Mayor Michael Bloomberg of New York City announced that his administration planned to look into having the city's health department and its hospitals buy prescription drugs from Canada.
Iowa is considering paying its pharmacies a $10 transaction fee to buy drugs from an approved Canadian wholesaler, said Kevin Concannon, director of the State Human Services Department.
Governor Tim Pawlenty (Rep.) of Minnesota said the state would study how much it might save if it bought prescription drugs from Canada. The state has over 500,000 employees and more than 600,000 others who receive medical care through the state's expense. He thus became the third governor to request such a study. The other governors who have requested that their state study the matter are Gov. Tom Vilsack of Iowa and Gov. Rod. R. Blagojevich of Illinois. Minnesota will move ahead with its plans even in the face of objections by the federal government. Similar to New Hampshire the state will be setting up a Web site through which its citizens will be able to buy drugs from Canada.
Governor Pawlenty announced that he would set up a Web site to allow residents to by prescription drugs from Canada. He also stated that he would attempt to set up a meeting with other state's officials who would be willing to set up a plan wherein all the states would combine to enable their residents to be able to buy drugs from Canada through the Web. Mike Hatch, Minnesota's attorney general said he is well aware of the fact that the FDA may oppose the plan in court, but that the state feels that such a plan would be legal.
Governor Rod R. Blagojevich of Illinois stated that he might follow in the footsteps of Mayor Michael Albano of Springfield, Mass. in encouraging municipal workers, their families and retirees to purchase their prescription drugs from Canada. The state of Illinois spent over $340 million this year to provide drugs for the state's 230,000 current and retired employees. That figure is projected to grow by 17% next year. Governor Blagojevich said that he would ask the federal government to give his state special permission to buy its employees' and state retires' prescription drugs from Canada, since a study that he had ordered be made showed that these drugs could be purchased with assuredness as to their safety. According to his estimation the state could save about $91 million of the total of $340 million that the state spent in 2002 for their prescription drugs.
Gov. Blagojevich has asked his staff to study the issue and report back to him by no later than December on what the cost savings might come to. In realizing that a conflict could arise with the federal regulations on this matter he stated: " We're not going to violate the law, we're going to urge a changing of the law." The governor and his staff will try to determine how they can import the drugs from Canada and yet not violate the U.S.laws on this matter. FDA Commissioner Mark McClellan reiterate the agency's warning that any violation of the law by a municipality will be punished by the federal government.
The FDA recently wrote to the state of California reminding it that state, city and county governments that urge and encourage their employees to import drugs from Canada are in violation of the federal law in doing so. Peter J. Pitts, associate FDA commissioner for external relations explained that the purpose of the letter was to remind the municipalities of the danger in importing drugs from Canada.
At the same time the FDA started an investigation of the Canadian drug company, CanaRx Services, that is being used by the city of Springfield, Mass. to supply the drug needs for the city's workers, their dependents and the city's retirees. Senior FDA officials stated that the agency has sent a letter to CanaRx warning them that they are in violation of the U.S. laws by encouraging Americans to seek out the Canadian drugs.
The Medicare and prescription drug revision bill recently passed by Congress allows for the importation of prescription drugs from one country only, and that country is Canada. This exception will be allowed only if the Secretary of Health and Human Services Tommy Thompson " certifies to the Congress that the implementation of this section will - 1) pose no additional risk to the public's health and safety and 2) result in a significant reduction in the cost of covered products to the American consumer." FDA Commissioner Mark B. McClellan has already stated that he will not attest to the safety of these drugs being imported from Canada so in affect it will be illegal to bring in prescription drugs from Canada.
In reality what this means is that in all likelihood the individual will be able to bring these medications in for their own use, but that any attempt to bring in large quantities of drugs such as Springfield Mass. is doing will be deemed illegal and the government will try and stop it. It also means in all probability that the government will attempt to stop those companies who have set up kiosks in the U.S. that help Americans bring these drugs into this country. The FDA recently began targeting CanaRx Services Inc., an Ontario mail-order prescription services company that delivers drugs to employees and retirees in Springfield Mass., under a city health insurance plan.
Canada's Health Minister Anne McLellan stated: "Obviously, the U.S. can't be interpreting Canadian law." She went on to say that Health Canada has investigated all information provided to it by the FDA but hasn't found any evidence substantiating the claim of a flow of unsafe drugs being shipped from Canada to the U.S.
A U.S. group of doctors and pharmacists, the Internet and Mail-Order Pharmacy Accreditation Commission (Impac) has been set up to certify Internet pharmacies. So far Impac has certified only Canadadrugs.com. Seven more sites will be certified shortly by the organization. The Internet pharmacies and/or drug companies do not fund it, but the pharmacies do pay a $20,000 fee to be considered for accreditation. We question how independent their findings can be when the applicant pays such a substantial fee to be accredited.
On the other hand we have Minnesota's attorney general Mike Hatch asking a federal court to compel GlaxoSmithKline to produce documents related to the company's attempt to restrict supplies of its drugs to online pharmacies in Canada. The attorney general contends that Glaxo and the other drug companies that have also cut back on the supply of their drugs to Canadian outlets are in violation of the anti-trust laws by colluding to cut off supplies of drugs to Canada.
Glaxo has responded that it is entitled to cut off supplies to the Canadian pharmacies because it is upholding the U.S. law in doing so. The company also contends that Mr. Hatch has no jurisdiction to compel the production of company records in Canada. Mr. Hatch stated that he selected Glaxo to be the main defendant in the case because they were the first drug company to restrict its supply of drugs to Canada.
The FDA and Canadian health authorities have agreed to share information about potentially unsafe drugs on the market. This pact is not intended in any way to mean that the Canadian government will restrict the flow of drugs from Canada to the U.S. The memorandum of understanding between the FDA and the Canadian health ministry known as Health Canada is aimed at curbing pharmaceutical sales of potentially unsafe products and illegal marketing practices that occur in the industry.
Several brand name drug companies have raised drug prices anywhere from 4% to 8% since last summer in Canada. Inflation in Canada is running at the 2% mark so far this year. The drug industry agreed to price controls in Canada in the early 1990s, in exchange for which the government ended a compulsory licensing system, which allowed generic versions of drugs to be produced before the expiration of the patent for the drug.
Sylvie Dupont, secretary of the Patented Medicine Prices Review Board in Ottawa, which regulates drug prices for all of Canada, stated that drug companies were not legally required to obtain the board's approval before raising prices. The manufacturers have to notify the board every six months of price increases during that period. The board has the power to roll back "excessive increases". "Excessive increases" are those increases that are substantially greater than the rate of inflation. The next notifications are due in January. In general it has been several years since the drug companies have increased their prices in Canada.
Krista Arpe, a spokeswoman for the health department in Ottawa, said there was no evidence that Internet pharmacies were posing an unacceptable health risk or that there was a shortage of drugs in Canada. Some Canadian pharmacy regulators have asked for the federal government in Ottawa to ban the export of drugs because of the possibility of drug shortages in Canada. Dr. Mark B. McClellan, the FDA commissioner, said that he would not rule out legal action against cities or states that break the law by importing drugs from Canada. David MacKay, executive director of the Canadian International Pharmacy Association, said that critics of the cross-border trade were motivated by unfounded fears of shortages or inferior products. "It’s a contrived threat that's being propagated by the large pharmaceutical companies."
The Canadian International Pharmacy Association, which is a trade group for Canadian Internet pharmacies estimates that total sales by its members will reach about $800 million this year, and it projects that these sales will increase to over $1 billion in 2004. A Canadian pharmacist group, the Canadian Pharmacists Association asserts that these sales are now causing shortages of certain prescription drugs in Canada. Canadian health authorities have stated that they do not see any evidence that such is the case, but Health Canada Assistant Deputy Minister Diane Gorman sees this as a potential problem down the road.
PharmacyChecker.com, an independent research firm that evaluates online pharmacies and compares prices, found that 6 of the 20 online Canadian pharmacies did not have verifiable affiliation with a licensed pharmacy. PharmacyChecker researchers checked out in detail the first 20 Web sites listed in a Google search in September for Canadian online pharmacies that ship medicines to the U.S. The research firm found that several of the firms did not provide secure financial transactions, didn't ensure privacy of information or did not provide reliable contact information.
Only six of the 20 sites met all PharmacyChecker's criteria for protecting consumer safety and privacy, and these 6 were all online extensions of licensed brick-and-mortar pharmacies. PharmacyChecker's offers a seal of approval for the Web sites that meet its criteria.
The schizophrenic nature of the battle going on in connection with the importation of prescription drugs from Canada continues to make headlines in the media almost every day. On the one hand we see the governors and other elected officials of the state moving towards allowing their residents and employees to import the drugs. The savings from doing this could be of enormous help towards reducing their budget deficit problems, especially in connection with Medicare and Medicaid drug costs. On the other hand we have the state's pharmaceutical boards seeking to close down the storefront stores that seek to ease the importation of these same drugs.
The state boards claim the storefronts are performing pharmacy functions such as handling drugs, processing medical records and/or advertising pharmacy-like services. The storefronts claim that they do not store drugs on their premises and merely take and ship the orders to the residents without having performed any pharmaceutical services at all.
North Carolina, Oregon and Indiana are among the states taking steps to shut down the operators either by sending them warnings or going to court to get injunctions to close down their operations. New York, Oklahoma and Montana regulators have already closed down several of these storefront drug stores in their areas.
The FDA and the Justice Department have brought a suit against a major storefront operation against Rx Depot Inc. of Tulsa Okla. The case is now pending in the U.S. District Court in Tulsa, Okla. and a decision in the case is expected next month.
On the other hand twenty-two members of Congress have signed a letter to Attorney General John Ashcroft asking him to investigate whether or not the pharmaceutical industry has violated antitrust laws by restricting sales to Canadian wholesalers and pharmacies that export drugs to the U.S. The letter is on the stationery of Representative Gil Gutknecht (Rep.-Minn.) who has sponsored legislation that would allow legalize the importation of drugs from Canada and Europe.
At the same time Minnesota's Attorney General Mike Hatch has announced that he is investigating GlaxoSmithKline for its efforts to restrict the sale of its products to Canadian wholesalers and pharmacists who in turn export the drugs to the U.S. There are many medical and legal experts who feel that the Canadian pharmaceutical authorities have as many safeguards as does the FDA to insure the safety of Canadian drugs that would be sold in this country. There is technology available today that could also insure against the sale of counterfeit drugs sold in this country.
Mayor Michael R. Bloomberg, (Rep.) of New York City signed a petition circulated by Governor Rod R. Blagojevich of Illinois calling on the federal government to allow cities and states to import prescription drugs from Canada. The mayor said that the city could save over $108 million in Medicaid prescription drug costs per year.
At last count there were over 140 online pharmacies operating from Canada, with 62 of them being registered in Manitoba. In 1999 there were only 10 Internet pharmacies in Canada. In spite of the attempts by many of the large brand name drug companies to restrict their supply of the drugs, they continue to flourish. They estimate that they now serve over 1 million customers from the U.S. The drug companies that have tried to restrict their supplies are Pfizer, GlaxoSmithKline, Wyeth, Eli Lilly and AstraZeneca.
The FDA and customs officials conducted spot inspections during two three-day periods at mail processing centers in Miami, New York, San Francisco and Carson, California. The purpose of the inspection was to check on the number and quality of imported prescription drugs into this country from several foreign nations. They pulled out 1,153 packages that appeared from the outside to contain drugs.
Of the 1,153 packages that were pulled out for inspection, 1,019 contained unapproved drugs in them. William K. Hubbard, an associate FDA commissioner stated that the pending proposal to legalize the importation of drugs into this country: " would open up the floodgates to many of these drugs and would encourage folks with the government's imprimatur to buy drugs that nobody has any regulatory authority over."
Representative Gil Gutnecht, (Rep.-Minn.) a sponsor of the pending legislation, which passed in the House this year, to legalize the importation of the drugs from overseas responded: "The FDA's blind refutation of fact and its duplicity in making safety claims are predictable and pathetic,". He also stated that there have been very few complaints about the quality of the drugs that were imported from Canada made to him by his constituency.
Robert B. Fraser, the director of pharmacy for CanadaDrugs.com, one of the largest drug exporters refuted the FDA's claim. He stated the "The products that we use are all approved by the Canadian version of the FDA." "Anyone can come see for themselves." Later in this article we wrote about how the U.S. government is attempting to stop one of the Canadian drug exporting companies from sending its products to the U.S.
The Justice Department sent a letter to the largest of the drug store chains that import drugs from Canada for sale to U.S. residents advising the company that it would seek an order in federal court to shut down the company's operation. The company in question is Rx Depot whose president Carl Moore o stated: "We're not going to stop, and we're going to fight for the right of senior citizens to buy affordable medicines."
Many Americans have been crossing the borders between this country and Canada, Mexico or even going overseas because of the cheaper prices for prescription medications in these other countries. Many storefront stores have opened in this country that help our residents obtain these drugs without having to make a trip across the borders. Rx Depot is the largest of these type of stores since it has 85 stores located in 26 states and plans to open about one store a month for the foreseeable future.
State pharmacy boards in Alabama, Arkansas, and Oklahoma have cracked down on these stores alleging that they were dispensing prescriptions without appropriate state licenses. The U.S. House of Representatives has passed legislation that would legalize the importation of prescription drugs on an individual basis but the Senate has failed to act so far on this measure. Representative Gil Gutknecht, a Minnesota Republican sponsored the measure.
Instead of singing "Oh Canada" the FDA seems to be singing "No Canada" in connection with the importation of prescription drugs from Canada. As more and more municipalities look to save money in an effort to narrow their budget gaps, the high cost of prescription drugs is one of the key areas where they are looking to garner these savings. This is especially true in regards to Medicaid drug costs as well as the soaring bills of their employees and retirees even with the higher premiums and deductibles that their employees are faced with.
So far the Canadian pharmacies are refusing to buckle under to the pressure caused by the 4 large drug makers to restrict the exportation of cheaper Canadian drugs to U.S. customers. The four drug makers, GlaxoSmithKline PLC, Wyeth, AstraZeneca PLC and Pfizer Inc. have taken steps to limit the availability of drugs to the Canadian exporters.
Pfizer was the latest of the drug manufacturers to take this action, and in Pfizer's case what they did was to order 46 Canadian pharmacies to buy directly from the company instead of buying through their normal wholesalers. The action of the drug makers has resulted in about a 22% increase on average in the prices of the prescription drugs sold by the Canadian Internet pharmacies.
According to the latest figures from IMS Health, a pharmaceutical information company, Americans are buying about $650 million of drugs from Canada annually. Scarcer supplies are bound to push up the prices for both Canadian and Americans. Health Canada, the Canadian health agency that monitors the drug industry in that country, said that it is monitoring the situation very closely, both from the point of view of cost for drugs to Canadians, and also availability of the drugs to Canadians.
Pfizer Inc. became the fourth major drug manufacturer to try and crack down on Canadian pharmacies selling low cost prescription drugs to American consumers. The company sent a letter to 46 pharmacies in Canada requiring them to buy their drugs directly from the company rather than from a wholesaler. By doing this, Pfizer can then enforce a standard clause in their contracts that bar them from exporting the drugs to the U.S.
Pfizer thus follows in the footsteps of GlaxoSmithKline PLC, AstraZeneca PLC and Wyeth, the other drug companies that have attempted to slow the exporting of cheaper Canadian drugs to consumer in the U.S. These letters fly in the face of the recent legislation passed on July 25th in the U.S. House of Representatives that would allow the American consumer to import prescription drugs from Canada.
According to a report by a Canadian health agency, drug prices in the U.S. were 67% higher than were drugs in Canada. The U.S. is the only industrialized nation in the world that does not have some form of price controls in place for drugs. Fifty-three senators have signed a letter in which they opposed the importation of drugs because of fear as to the safety of the imported drugs.
At a hearing held by the House Subcommittee on Human Rights and Wellness the FDA was berated for attempting to limit the right of individuals to bring prescription drugs into this country from Canada. According to Rep. Bernard Sanders, the Vermont Independent: " You should be putting out pamphlets saying people have been going across the border… and there hasn't been one problem." Rep. Dan Burton, an Indiana Republican stated " You scare the hell out of them, " when in fact there is no need to be doing that.
Many of the lawmakers said there is no evidence of a safety problem. FDA Associate Commissioner William Hubbard said the FDA is focusing its enforcement efforts on businesses, not individuals who are purchasing drugs in foreign countries or over the Internet for their own usage and not for commercial purposes.
According to the Manitoba Pharmaceutical Association, a provincial pharmacy regulator, the number of Internet pharmacies in Manitoba mailing prescription drugs to Americans has risen to 51 from 30 in January. More than half of Canada's 80 Internet pharmacies are based in Manitoba, where the provincial government supports them as job-creation vehicles. The rising number of drug shipments is starting to cause drug and pharmacist shortages in Manitoba, prompting the fear that the drug makers will stop marketing new products in Canada. In 2002 drug sales in the U.S. totaled $192 billion while sales in Canada totaled about $9.98 billion in U.S. dollars. It is estimated that sales by the Canadian Internet pharmacies will be about $1 billion this year. Internet pharmacies on average pay about C$120,000 a year to its pharmacists, which is about double what the pharmacists are paid at the 299 walk-in pharmacies in Manitoba.
The import of a letter dated February 12, from William K. Hubbard, the FDA associate commissioner for policy and planning to an attorney Robert P. Lombardi, indicates that the agency will begin to crack down on the importation of cheaper prescription drugs to this county from Canada. The letter was sent in response to questions from Mr. Lombardi a New Orleans attorney who did not specifically identify who his clients were in this matter other than to say that they were several health plans.
In his letter Mr. Hubbard wrote that all parties "who cause a prohibited act " can "be found civilly and criminally liable" under the federal Food, Drug and Cosmetic Act. "Those who aid and abet a criminal violation of the act, or conspire to violate the act, can also be found criminally liable". The letter also stated: " Any party participating in" an import plan in which a "health insurer or claims processor helps arrange a purchase in Canada "does so at its own risk."
This letter was not aimed at the individual consumer who imports the medicine from Canada either via the Internet or by actually physically bringing it back from Canada for the consumers own use. It would seem to us that the letter is aimed at some of the other parties that we discussed in an earlier part to this article.
GlaxoSmithKline, Plc, the English drug company became the first large drug maker to threaten to stop selling its drugs to its wholesalers and retailers in Canada, unless they stopped selling Glaxo's drugs over the internet to U.S. customers. In a letter sent to the wholesalers and some of the retail pharmacies that Glaxo supplies with it drugs, it threatened to withhold supplying drugs after January 21 to those who knowingly sell to U.S. customers. Glaxo's reasoning for taking this action was because the company feared that drugs could be harmed in the shipping process and that the doctors who are prescribing the drugs were not properly supervising Americans buying drugs in Canada. Eli Lilly & Co. notified its wholesalers in Canada that if they supply Canadian pharmacies that sell drugs in the U.S. they would be violating Lilly's contract with the wholesalers.
The October 21, 2002 issue of the Wall St. Journal had an article written by Sarah Lueck entitled "Upstart Texas Firm Makes a Stir With Cheap Drugs From Canada." The company named in the article is SPC Global Technologies Ltd of Temple Texas. It offers a way for about 20,000 people enrolled in health plans that are SPC clients to obtain medicines from Canada. The letter from Mr. Hubbard may mean that this practice is now going to be considered illegal by the FDA.
The company has a list of about 250 drugs that are available for its clients who are enrolled in some health plans. "The patients obtain a prescription through their U.S. doctor and order the drugs through SPC's affiliate Expedite-Rx, which is also based in Temple. That company places the order with Cross Border Pharmacy Ltd,. A closely held licensed pharmacy in Calgary, Alberta, which forwards the order to Canadian doctors. They rewrite the prescriptions, as required by Canadian law. Cross Border then fills the prescriptions and sends the drugs to the beneficiaries."
The same William K. Hubbard, of the FDA, declined to comment on the SPC system, but again according to the article did say that such companies as SPC "aren't necessarily doing anything wrong because they don't actually handle the drugs." To see further information on the Canadian Web drug companies see our article Medicare and Prescription Drugs-Part I.
A drug reimportation law was passed in 2000 and President Clinton did allow it to become the law. Since the then Secretary of Health and Human Resources Donna Shalala felt that she was unable to certify the safety of the labeling on the re-imported drugs as required by the new law, the law never went into effect. The present Secretary of Health and Human Services, Tommy Thompson has also stated that he would not be able to certify the safety of the labeling of the reimported drugs.
Senator Dorgan said he plans to attach his proposal this summer to the fiscal 2003 agriculture appropriations bill, which includes the financing for the FDA. Representative Gil Gutknecht (Rep.-Minn.) said that he would introduce a reimportation bill in the House, which would allow the reimportation from more countries than only Canada. Senator Susan Collins (Rep.-Me.) said that she would also introduce drug reimportation legislation in the Senate in the coming session. Other Senate sponsors include Sen. Deborah Stabenow (Dem.-Mich.), Sen. Olympia Snowe (Rep.-Me.) and Sen. Jim Jeffords (Ind.-Vt.).
It seems as if Congressmen from both sides of the aisles are going to push for a drug reimportation law this coming session. According to Senator Dorgan " One of the big domestic issues is the increasing cost of prescription drugs, and U.S. consumers pay more than anybody else,".
The Department of Health and Human Resources and the drug industry oppose the drug reimportation law, even if the reimportation is limited to Canadian sources. The opposition is based on the increased chances of counterfeit or contaminated drugs entering the U.S., and the labeling problem also.
We are all familiar with car, bus and train trips organized to go to places like Canada and Mexico with the avowed purpose of purchasing prescription drugs at much cheaper prices than in the U.S. One of the methods that the elderly have employed to help reduce their drug costs is to order the prescription drugs from overseas suppliers. Even though it is illegal to have prescription drugs shipped to you from overseas the Customs Bureau has been overlooking the law if the package contains shipments intended for one individual only.
This is about to change if the FDA has its way. The FDA has asked Health and Human Services Secretary Tommy Thompson to approve the recommendation that U.S. Custom Service agents at mail-inspection sites be required to send back all small foreign drug shipments they find. The only exemption would be for "compassionate use", so that seriously ill patients could order drugs from overseas that are unavailable in the U.S. While tougher enforcement is not likely to occur shortly the FDA's recommendation is supported by the U.S.Customs Bureau.
The January 18th, 2001 of the Wall Street Journal contained an article by Laura Johannes entitled "Canadian Web Drugstores Offer Deep Discounts and Legal Quandaries". We will summarize the article for you but we suggest that you read it in full so that you will be better able to make a fully informed decision on this matter.
There are now over 50 Web sites that can be used to purchase prescription drugs at Canadian pharmacies that can save U.S. residents anywhere from 20% to 50%. Ms Johannes article went on to state that "Ordering drugs from Canada to save money is technically illegal in the U.S., though authorities so far have mostly looked the other way" as long as the purchase is being made for the individuals own use.
Tom McGinnis, director of pharmacy affairs at FDA headquarters in Rockville,
Md. stated: "We haven't been going after individuals because we don't have
the manpower". This policy as stated above may change if Congress
allocates sufficient funds for the U.S. Customs Bureau to enforce the law.
The article also points out that U.S. residents can also get generic versions of some prescription drugs that are not available in this country. Each of the three Canadian websites stated that they operate within the Canadian law, which allows pharmacies to fill prescriptions only if signed by a Canadian licensed doctor. The three largest Canadian drug websites are: CanadaRX.net, TheCanadianDrugStore.com, and Canadameds.com. Manitoba, Canada has seen over 27 sites arise in the province in the last 4 years. MedOutletCanada.com and PayLessMeds.com are two of the sites that have arisen in that province which is just north of North Dakota and Minnessota. The Canadian government caps the prices for prescription drugs in that country.
CanadianDrugstore has a Canadian doctor review the U.S. patient's medical history before co-signing the prescription. It charges $50 for the review but the customer can still come out ahead if he is buying up to a 3 months supply of an expensive drug. CanadaRX mails the medications to the patient's U.S. doctor. It article points out that the savings from theCanadianDrugStore over the U.S. based Drugstore.com was as much as 64% for Tamoxifen to as little as 26% for Lipitor or 30% for Prozac.
One of our viewers was kind enough to e-mail us with the web address and toll free number of another Canadian drug web site. The site is Canadameds.com and their toll free number is 1 877 542 3330. We recommend that you compare the prices and costs on all four of these sites to see which one is best suited for your own needs.
The following is an exchange of e-mails that we received from Mrs. Billie Woods, and an excerpt of the answer to it from Harold Rubin, one of the co-editors of therubins. We would like to emphasize that we at therubins are not medical doctors. We try to answer the e-mails sent to us to the best of our ability, but you must rely on your own physician's advice when making your determination as to treatment for a medical problem.
From Mrs Billie Woods
My husband has been diagnosed with a rare disease, Chromoblastomycsis, and the drug prescribed is Sporanox. We have no insurance and have barely afforded a few weeks of the prescription and are desperately needing help to pay for this expensive drug. Can you tell me what to do or where to go for help?
Thank you for your time!
Response from Harold Rubin
Dear Ms. Woods:
We empathize with the frustration you are experiencing around the cost of medication to treat your husband's chromoblastomycosis, a chronic fungal infection in which there are raised lesions usually on the limbs. ….
"There are a number of avenues you can go down to try to obtain the medication. First, have you tried contacting (which drug company is the manufacturer of the drug) and discussing with them your indigent condition. They may have a program for individuals like your husband to obtain the medication at no cost at all, or at a minimum cost. Second, does your state have any program for individuals who have difficulty paying for medications? Third: Is your husband a veteran? If so, he can try the VA as a source of medication at very low rates. Fourth: Have you discussed your difficulty in paying for the medication with your husband's treating physician? He/she may know of a program to help you, or may be able to supply you with samples of the drug. Fifth: there may be drug companies in Canada that may provide the medication at prices much lower than USA. Please look at the article on our web site on Medicare and prescription drug costs part I which will give you ( the address of web sites) in Canada. We are in no way connected with any of these companies, so you will have to do your own research."
Our hope is that the above information will prove helpful to you. Feel free to contact us if we can be of further help to you.
Please tell your friends about our site. We are a public service site, beholden to no company or association. We believe in the sharing of information and strengthening of services for the elderly. Thank you for looking at our site.
For our other articles in this series please see:
Medicare and the Cost of Prescription Drugs-Part I
Medicare and the Cost of Prescription Drugs-Part II
Medicare and the Cost of Prescription Drugs-Part IIa- Medicare and Medicaid Drug Spending
Medicare and the Cost of Prescription Drugs-Prescription Benefit Managers-Part III
Prescription and Generic Drug Costs- Part VI
Medicare and Prescription Drug Costs- Part VII
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home
By Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated December 23, 2019
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