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The Food and Drug Administration (FDA)- Part II of a II Part Series

To see Part I in this series please go to "The Food and Drug Administration (FDA)-Part I"

(8/11/17)- The Food and Drug Administration (FDA) has approved 633 applications for pharmaceuticals through July, which with 2 months to go to the end of its fiscal year, leaves it within striking distance of the record breaking pace of 651 approvals set in 2015-2016.

Since Dr. Scott Gottlieb was appointed to head the agency in May, there have been 233 approvals granted.

More than 2,400 applications are now pending with the FDA’s review panels, and Dr. Gottlieb has promised to continue to speed up the whole approval timetable.

The FDA published a list of drugs that were no longer covered by patents with the aim of getting generic drug companies to start manufacturing some of these medications..

(8/8/17)- The Senate passed and sent on to President Trump legislation to fund the FDA by a 94 to 1 vote. The House had passed the user fee bill by a voice vote on July 12. The president has indicated he would sign the measure.

The FDA depends on the user fees collected from the pharmaceutical industry to finance more than one-quarter of its budget. The bill directs the FDA to speed the review of generic drug applications that have little or no competition in the market.

The tax on medical devices would be maintained under the legislation..

Earlier last week, the Senate passed a bill that expanded access to experimental drug treatment for people with terminal illnesses. The bill, called the Right to Try Act, will now go to the House when it reconvenes after its recess..

(8/4/17)- This interesting article came across our desk and we thought our readers might want to explore the possibility of using this program. It appeared in STAT: Pharmalot <newsletter@statnews.com> dated August 2nd.

When approved therapies don’t work, or stop working, for people with serious or life-threatening illnesses, it puts them in a difficult position. Some turn to clinical trials that are testing experimental treatments

 But many can’t do that because they are too sick, don’t meet the requirements of the trial, or can’t afford to travel to the site of a trial. That doesn’t mean they are out of options.

Patients and their doctors can request access to investigational treatments through a national program called single-patient expanded access, also known as compassionate use. It works like this: A physician submits a request to a drug company for access to an investigational medicine. If the drug company agrees, the physician must then get Food and Drug Administration approval before the company can supply him or her with the medicine.

The FDA approves more than 99 percent of the compassionate use requests it receives. Through this process, the FDA ensures that the medicine is being administered by a licensed practitioner.

 (6/22/17)- Dr. Scott Gottlieb, the new commissioner of the Food and Drug Administration, in testimony given to a Senate panel said that the agency would have to deal with the $700 million cut from their budget by President Trump’s May budget.

The $700 million proposed cut would come from the $5.1 billion that was allotted to the agency for the 2016-2017 federal fiscal year. The administration has called for making up the difference by raising fees on the pharmaceutical and medical device industries.

About $127 million of the cut would come from safety and surveillance of the pharmaceutical and medical device industries. The fees have already been negotiated between the FDA and the industry at much lower levels and probably will not be re-negotiated.

The pharmaceutical industry has contributed extra money to the FDA for the purpose of speeding up the process for the approval of new drugs..

(6/11/17). The Food and Drug Administration (FDA) has requested Endo Pharmaceuticals Inc. to remove its Opana ER from the market because the agency had concluded “the benefits of the drug may no longer outweigh its risks.”

Abuse of the drug, which is injectable, was linked to “ a serious outbreak of HIV and hepatitis C”. The outbreak occurred in Indiana in 2015, where addicts shared needles while injecting the drug. Endo’s parent company Endo International PLC said it is reviewing the request.

(5/11/17)-  The U.S. Senate voted 57-42 to confirm Dr. Scott Gottlieb, age 44, as commissioner of the Food and Drug Administration (FDA). Dr. Gottlieb has promised to recuse himself for one year from decisions involving any drug company that he had been involved in, and divest himself of stock in any health-care company that he had been a shareholder in.

Dr. Gottlieb had previously stated his opposition for allowing the importation of drugs from foreign countries because of safety concerns. Dr. Gottlieb had held various jobs before at the FDA during the George W. Bush administration, including deputy commissioner.

As the saying goes, what goes up must come down, and to the biopharma industry's chagrin, that’s exactly what happened to new drug approvals in 2016. Last year, the FDA logged 22 new drug OKs, a paltry total compared with the 45 that won a green light in 2015 and 41 in 2014. (From Fierce Life Sci Weekly Digest, accessed on Jan. 13, 2017)

(8/1/16)- Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.

(2/26/16)- Dr. Robert Califf, the acting commissioner and nominee to head the Food and Drug Administration (FDA), was finally confirmed to head the agency by a vote of 89 to 4 in the Senate on February 24. Strangely enough the nay votes came from Democratic senators, while their Republican colleagues strongly backed his nomination. .

Voting against Dr. Califf’s nomination were Democratic Senators Edward J. Markey of Mass.; Joe Manchin III of West Virginia; and Richard Blumenthal of Conn. Joining them in opposing the nomination was Republican Senator Kelly Ayotte of New Hampshire.

(2/7/16)- Senator Edward Markey (D-Mass.) became the latest legislator to put a hold on the nomination of Dr. Robert Califf, the acting commissioner and nominee to head the Food and Drug Administration (FDA), citing the agency’s lack of dealing with the nation’s opioid crisis.

The Senate’s Health, Education, Labor and Pensions Committee, as noted in our item dated 1/14/16 below, had voted to approve his nomination. As a further step in dealing with this crisis the agency announced several measures as it attempts to deal with the problem.

Dr. Califff also announced that the Obama administration would ask Congress to spend an additional $1.1 billion next year to increase the number of facilities dealing with those needing help in dealing with their opioid affliction.

The measures include convening an expert panel before approving new opioids, tightening of requirements to study a drug after it has come to market, an increasing access to training on pain management for medical professionals prescribing these medications.

(1/18/16)- Investigators from the government Accountability Office (GAO) concluded that there are flaws in the way the FDA tracks drugs after they came to market. The findings were contained in a report commissioned by Representative Rose DeLauro. (D.-Conn.).

Ms. DeLauro said she wanted to evaluate the FDA’s record in tracking problems with drugs, especially those that have been approved under the “fast track” approval system. Investigators determined that about ¼ of the drugs that had been approved from October 2006 to December 2014 were done under the “fast track” process.

The computer system the agency used did not allow for the sorting of issues by disease type, patient population or FDA action. The drug companies were also found to be deficient in reporting adverse reactions to their medications.

(1/14/16)- The Senate’s Health, Education, Labor and Pensions Committee voted unanimously to approve Dr. Robert M. Calif, a cardiologist and clinical trial expert from Duke University, as the commissioner of the Food and Drug Administration. Approval by the full Senate will not happen soon, because Republican Senator Lisa Murkowski of Alaska has pledged to block his candidacy over the agency’s approval of genetically engineered salmon.

Mrs. Murkowski said she would put a hold on Dr. Calif’s candidacy because the FDA approved a genetically engineered salmon for consumption days after she questioned him on this topic at the hearing in November. Please see our item dated 11/7/15 below.

Independent Senator and presidential candidate Bernie Sanders of Vermont may also put a hold on Dr. Calif’s nomination because he has not done enough to stop the rise in prescription drug costs.

(11/19/15)- Dr. Robert M. Califf, 64, President Obama’s nominee to head the Food and Drug Administration, was questioned for about two-hours, at a session before the Senate Committee on Health, Education, Labor and Pensions. Senators Elizabeth Warren, Democrat of Boston and Bernie Sanders, independent of Vermont peppered him with skeptical questions.

The reason for their skepticism was pointed out in our item dated 9/17/15 below. A date for the confirmation vote has not been set, but it appears that Dr. Califf’s nomination will be confirmed. 

(11/7/15)- Drugs.com, reported that the: FDA had approved an astounding 15 new drugs in the month of October ranging from Onivyde for metastatic pancreatic cancer to Vivlodex for osteoarthritis pain.

Other notable newcomers include Veltassa, an oral suspension to lower dangerous potassium blood levels, and the first oncolytic virus therapy known as Imlygic.

 (9/17/15)- The Obama administration announced that it had nominated Dr. Robert Calif, a cardiologist, and clinical researcher to be the commissioner of the Food and Drug Administration (FDA).  Dr. Califf has been the deputy commissioner for medical products and tobacco at the FDA since March. If his nomination is confirmed, he will replace Dr. Margaret A. Hamburg, who headed the agency for 6 years, until she resigned in March.

Dr. Stephen Ostroff has been the acting commissioner since she stepped down.

Dr. Calif, 63, had been associated with the Duke University Clinical Research Institute from 1982 until 2015, where he was the director. 

(5/16/15)- Is it a violation of the free speech amendment (First) to the Constitution if the Food and Drug Administration (FDA) forbids a drug company from promoting a drug for off-label purposes? Amarin Pharmaceuticals thinks so, and has filed a lawsuit against the agency in the U.S. District Court in New York to prove it has a right to do so.

The drug in question is Amarin’s only product, Vascepa, which is a prescription omega-3 fatty acid that has been approved by the FDA for usage to treat patients with extremely high levels of triglycerides. High triglyceride levels have been linked to heart disease. Amarin sought approval from the FDA for the drug to be used to a wider population of patients with severe levels, but the agency turned them down.

(4/24/15)- The Congressional Budget Office (CBO) estimated that the Food and Drug Administration  (FDA) would need funding totaling $580 million from 2011 through 2015 to carry out the changes mandated by the Food Safety and Modernization Act of 2010. So far, Congress has appropriated less than half of that amount.

Representative Rosa DeLauro, a Connecticut Democrat who helped to write the law continues to push for modernization of the agency. Last year it asked for $263 for the law, with about $229 million coming from user fees. Congress appropriated $27.5 million. It has asked Congress for $109.5 million for the coming year.

The Centers for Disease Control and Prevention has estimated that 128,000 people are hospitalized each year with food related illnesses, and 3,000 die.

(2/8/15)- Commissioner Dr. Margaret A. Hamburg, 59, head of the Food and Drug Administration (FDA), told colleagues in an email that she would depart the agency at the end of March. She has led the agency for almost 6 years, and her temporary replacement will be the FDA’s chief scientist, Dr. Stephan Ostroff.

The permanent new successor for Dr. Hamburg will need the approval from the Republican-controlled Senate. She is one of the longest-serving commissioners at the agency, after being nominated by President Obama, and confirmed by the Senate in 2009.

Dr. Hamburg recently noted that the FDA had approved 51 drugs in 2014, the most in almost 20 years.

(8/23/14)- The Drug Enforcement Administration (DEA), as the Food and Drug Administration (FDA) did nine months ago, said it would reclassify hydrocodone combination drugs such as Vicodin and put them in a category reserved for medical substances with the highest potential for harm.

This means that users of these drugs will need a new prescription to obtain them every 90 days. Currently the pills can be refilled up to 5 times on a single prescription, which can cover a 180 day period. The new classification will take effect in 45 days, according to a statement from the DEA.

Prescriptions for these medications will not be able to be phoned or faxed in by the medical prescriber. The patient must present the prescription to the pharmacy. In 2010, more than 16,000 people died after overdosing on opioid-based painkillers, according to figures from the Centers for Disease Control and Prevention.

About 127.86 million prescriptions were written and filled for this class of drug in 2013, down 6% from the prior year, according to IMS Health Holdings Inc., the drug data firm. Sales of this class of drug reached $1.05 billion in 2013, up 21% from 2012.

The drug will have to be kept in special vaults at the pharmacy. This restriction does not apply to Oxycodone or methadone, which account for more over dosage deaths than does hydrocodone drugs.

(1/30/14)- The FDA has banned the use and importation of all drugs into the U.S. that were made at the Toansa, India plant of Ranbaxy, Ltd. An official of the Japanese pharmaceutical company Daichi Sankyo Co., which owns more than 60 % of Ranbaxy, said it had sent some of its employees to India to “help support Ranbaxy toward the solution of the ongoing problem”.

Ranbaxy had reached a consent decree with the Justice Department in January 2012 over manufacturing quality issues. The decree required the company to take steps to ensure the quality and safety at three plants in India, not including the one in Toansa, and one in New York.

FDA inspectors had visited Ranbaxy’s Toansa plant early in January, and said they discovered workers retesting “until acceptable results are obtained” and deleting evidence of failed testing. The inspectors also noted that analytical and microbiological laboratories at the plane were in “significant disrepair”. Windows couldn’t close and a sample preparation room was filled with flies.

In September, the FDA blocked imports from Ranbaxy’s newest plant, in Mohali, in northern India.

The FDA is preparing to revise the nutrition labels on packaged food, the first major change in 20 years, the Associated Press reports. The new labels are expected to feature prominent calorie listings

(11/25/13)- A bill that would give the Food and Drug Administration (FDA) more power to regulate compounding pharmacies passed Congress and was sent on to the president for his signature on November 18. The president has indicated that he would sign the bill.

Drug compounders came into the limelight last year when a tainted injectable compound used in connection with steroidal spinal cortisone shots led to the death of 64 individuals since it caused them to come down with spinal meningitis.,

The bill, known as the Drug Quality and Security Act would allow compounders to register with the FDA as “outsourcing facilities”, which in turn would mean they would be subject to rules on quality control and oversight from the FDA.

Compounders that do not wish to register would be free to do so, but they would be allowed formulate only for individual patients on the basis of a prescription, or making limited quantities ahead of a prescription. These compounders would not be subject to open their records to federal inspectors, which would have to be subpoenaed if governmental officials wanted to inspect them.

All compounders are still subject to any state laws that may apply to them

(10/9/13)- Boehringer Ingelhim GmbHj said that it plans to shut down its Ben Venue Laboratories unit, which makes drugs for other companies, and for its own sales because of its inability to comply with standards set for it by the FDA at that plant. One of the drugs it manufactures at that facility is Johnson & Johnson’s cancer drug Doxil.

Johnson & Johnson in turn announced that because of “external difficulties” it expects shortages of Doxil to occur, which in turn caused a run on the small supply of the drug that was available in the market.

The Ben Venue facility is located in Bedford, Ohio, and Boehringer has asserted that it spent $350 million to upgrade the facility, but has still be unable to meet all the requirement for the plant that have been set by the FDA.

The closing of the plant will mean that the company will in turn have to lay off about 1100 employees.

(9/28/13)- The FDA plans to require makers of high-risk medical devices to put a unique identifying identifier (UDI) on all such products, as it attempts to create a warning system for devices that may break down and to post safety issues for patients.

The agency will maintain a database to determine if an adverse event is something rare, or part of a pattern of such events. It is aimed at heart defibrillators and heart valves in particular, as was the case in 2007 with Medtronic Inc.’s defibrillator wire malfunction, or “leads” in their Sprint Fidelis product.

(9/23/13)- The FDA issued an import alert for drugs made in Ranbaxy Laboratories Ltd.’s Mohali facility in northern India, which bans the importation to this country of any drugs made at that plant. The agency found “significant” violations of manufacturing rules, “including failure to adequately investigate manufacturing problems” during two plant inspections conducted in September and December 2012.

The FDA had issued similar alerts against two other Ranbaxy plants in 2008, and has yet to lift those alerts.

Ranbaxy will now be required to hire a third-party expert to inspect the facility at Mohali and certify to the FDA that any and all violations have been addressed and that the company has put processes in place to insure continuing compliance.

Analysts said that the plant was expected to produce a generic version of the blood-pressure treatment drug Diovan.

Ranbaxy is a subsidiary of the Japanese company Daichi Sankyo Company, when it was taken over in 2008

(7/6/13)- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.

These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.

(1/2/13)- The year-end push to wrap up FDA drug approvals resulted in ten new agents being hired in the month of December alone.

Highlights include the much-anticipated approval for Eliquis, a new stroke prevention anticoagulant, and the inhaled powder Adasuve for agitation in schizophrenia or bipolar I disorder.

Juxtapid and VariZIG are two new orphan drugs, and Iclusig was accelerated through FDA approval three months early for patients with rare blood and bone marrow diseases.

(12/3/12)- Ranbaxy Pharmaceuticals, the Indian drug company, a subsidiary of the Japanese pharmaceutical company Daiichi Sanko, has halted production of atorvastatin, its best selling generic version of Lipitor because of contamination.

The company has been operating under a court-ordered consent decree since January after the FDA found a multitude of manufacturing problems at the company's plants in India and the United States. Foreign drug manufacturing plants are inspected about once every 7 years compared to the 2 year inspections done for drug plants in the U.S.

The Generic Drug User Fee Amendments of 2012 (Gdufa) has provided the FDA with funding for the addition of inspectors overseas, so that foreign drug manufacturing facilities can be inspected more frequently.

Ranbaxy's genreic version of Lipitor accounted for 41% of prescriptions of atorvastatin in October according to an analysis by Michael Faerin, an analyst for Credit Suisse who used data from the drug research firm IMS Health.

(10/15/12)- The month of September saw the approval of Stivarga, a drug that can improve survival time for patients with metastatic colorectal cancer, and a new indication for Humira for the treatment of ulcerative colitis. The FDA also gave the go-ahead for Aubagio, a new immunomodulator for multiple sclerosis, and Bosulif, a tyrosine kinase inhibitor for chronic myelogenous leukemia. Finally, the release of generic Diovan HCT brings potential cost-savings to patients with high blood pressure

(8/2/12)-The number of people who die as a result of drug resistant bacteria continues to climb to higher and higher levels. Congress in passing the FDA funding bill added the Generating Antibiotics Incentive Now (GAIN) provision to help in the battle.

The provision cuts the FDA drug review period of time down from 12 months to 8 months. To further encourage scientists and pharmaceutical companies with a financial reward, marketing exclusivity was extended by up to 10 years.

(6/26/12)- The European Medicines Agency, which is Europe's main drug regulator, said it is investigating Roche Holding AG for failing to properly investigate 80,000 reports of possible drug-safety issues relating to U.S patients received from patients and doctors.

European inspectors found the unvetted drug reports during a routine inspection of a Roche facility in the U.K.

These included 15,161 reports of patients' deaths, though it is not known whether the deaths were due to "natural progression of the disease" or to some problem with the drug, the EMA said. The FDA is working with the EMA on this matter. Roche has been given until June 27 to review the reports and forward any serious cases to the agency.

(6/23/12)-The House, in a bipartisan vote, passed a measure that would allow the Food and Drug Administration (FDA) to collect about $6 billion in user fees over a five-year period of time from the brand-name, generic and medical device industries.

The measure now moves on to the Senate, which is expected to approve it and send it on to the president for his signature. The bill also increases funding for the agency to allow it to inspect foreign drug plants more frequently. The Senate previously had approved the funding bill by a 96 to 1 vote.

(6/18/12)- The Food and Drug Administration is investigating whether Fresenius Medical Care, the nation's largest operator of dialysis centers violated federal regulations by failing to inform patients of a potentially lethal risk associated with one of its products.

In addition to treating more than a third of the estimated 400,000 Americans receiving dialysis at its own centers, it is also the leading supplier of dialysis machines and disposable products to other dialysis centers.

An internal memo that was leaked to the FDA showed that the company in November warned the doctors at its own clinics that failure to properly use one of the its products, known as GranuFlo, was contributing to a sharp increase in the risk of patients dying from cardiac arrest.

Fresenius, which is based in Germany did not warn the companys that were not part of its network until the FDA questioned them on this matter.

The Fresenius memo, dated November 4, 2011 stated that 942 patients had suffered cardiac arrest inside their own clinics in 2010. Amazingly enough, all that the FDA can do if the allegations are correct, is to send Fresenius a warning letter.

(6/9/12)- The House voted 270-146 to repeal a tax manufacturers of medical devices that was intended to pay for expanding coverage to uninsured individuals under the new Affordable Patient Protection Act of 2010.

37 Democrats joined with their Republican colleagues in favor of ending the tax. The measure would apply a 2.3% tax on the sales of most medical devices, and is scheduled to take effect in January. The tax exempts goods such as contact lenses, hearing aids and eyeglasses.

(6/3/12)- We spoke too soon when we wrote in our item dated 5/29/12 below that it looked like bipartisanship would prevail in Congress in connection with the pending FDA funding bill. Even though the Senate passed the measure by a 96 to 1 vote, lobbyists are going to work in the House to make some changes that may throw a roadblock in the path of the passage of the legislation.

In particular, Endo Pharmaceutical (which is in the process of changing its name to Endo Health Solutions) wants to protect the patent rights for its pain relieving medication Lidoderm, which had about $825 million in sales last year, which represented about 30% of the company's total sales. Lipoderm is used to reduce the pain level for patients suffering from shingles.

Endo has hired as lobbyists Bart Stupak, a former Democratic representative in the House for 18 years, and William R. Norwind, who worked for over 10 years for Representative Fred Upton, who is the chief sponsor of the legislation in the House.

Endo is attempting to gain an exception for Lipoderm on the technical issue of measuring the bioequivalency differences between its brand name drug and the generic versions thereof, which Watson Pharmaceuticals and Mylan are hoping to be able to introduce into the marketplace.

(5/29/12)- As expected, the Senate voted 96 to 1 to renew the existing law that provides funding for the Food and Drug Administration. The vote was a rare display of bipartisanship in Congress, with only Senator Bernie Sanders, the Liberal from Vermont voting against the legislation. The House is expected to act on similar legislation this week.

The $4 billion that the brand-name drug companies would pay from 2013 to 2017 would pay about 60% of the agency's cost of reviewing their products.

The $1.5 billion in fees that the generic drug industry would pay for the first time, would go to speed approvals of generic drugs and to help pay for more inspection of medical facilities in countries like China and India.

The new legislation would give the FDA power to block products' entry into the US is the FDA were refused admission to fully inspect facilities. Medical device companies would pay-in about $600 million to help alleviate the cost involved in the approval process for their products.

(5/24/12)- The Senate is expected to vote as early as next week on legislation that would greatly expand the power of the Food and Drug Administration. A similar bill is pending in the House, and the measure seems to have bipartisan support.

Under the proposed new law, brand-name drug companies would pay about $4 billion in user fees over 5-years, and medical-device companies would pay about $600 million over that same 5-year period of time.

Generic drug companies will, for the first time, pay about $1.5 billion in user fees to pay for faster product reviews. The "bio-logic" industry would also pay user fees, since generic version of their drugs will be allowed under President O'bama's new health care law.

The current law for the fees is scheduled to expire September 30th,and unless the new fee structure is in place by then, the FDA would not have adequate funding for many of its needs.

Proposals in the new law would give the agency power to regulate foreign raw materials that make up about 80% of the ingredients in our medicines.

Under present conditions the FDA inspects US drug plants abut once every two years, whereas it inspects foreign drug plants once every 9 years, if then. The new law would provide funding for more frequent inspections of foreign plants by increasing the staffing for making these inspections overseas.

(4/6/12)- Noteworthy FDA drug approvals in March:

Omontys (Perinesatide) - From Affymax and Takeda Pharmaceutical Co. Ltd.-a new red blood cell booster for anemic dialysis patients with chronic kidney disease.

QNASL (beclomethasone deprpionate) - From Teva Pharmaceutical Industries Ltd.-a dry nasal spray to combat seasonal and year-round allergies

Surfaxin (Lucinactant)- From Discovery Laboratories Inc.-a critical lung surfactant for premature infants to aid in breathing.

Two new pancrelipase products, Ultresa (Pancrelipase) From Aptalis Pharmaceutical US Inc. and Viokase (Pancrelipase)- From Aptalis Pharmecutical US Inc. were approved

Binosto (Alendronate)- From EffRx Pharmaceutical SA- an easy-to-swallow osteoporosis tablet that can now be dissolved in water helps the medicine go down.

(11/11/11)- The Food and Drug Administration approved 35 new drugs (NDAs) in the year that ended in September as opposed to 31 new drug applications in 2010, 37 in 2009, and 24 in 2008. In 2007 the agency approved only 17 new drug applications.

Twenty-four of the new drugs were approved for usage by the agency before they were approved in any other country in the world.

Included in the new drug approvals were the first new drug to treat lupus in 50 years, the first new drug for Hodgkin's lymphoma in 30 years, and the first drugs for late stage melanoma that have been shown to prolong survival.

There still has not been any finalization of the new fee structure agreement that was reached between the agency and the pharmaceutical industry as we discussed in out item dated.9/6/11 below.

(9/6/11)- The Food and Drug Administration (FDA) has reached an agreement with the pharmaceutical industry on a five-year plan that will increase the industry's fee payment to the agency by about 6% and will help speed up approvals for new drug applications.

The agreement has to be approved by Congress, but that is not expected to be an obstacle. Currently the user-fee paid by the industry provide about 62% of the total of more than $930 million that the FDA spends annually to review applications for new drugs.

The fees were created by the 1992 Prescription Drug User Fee Act. Congress re-authorized the user-fee program in 2007 for an additional five-year period of time.

Both the generic drug industry and the medical equipment industry are in discussions with the FDA in connection with their respective user-fee programs. Whereas the generic drug industry is close to an agreement with the agency on this matter, the medical equipment industry and the FDA are still trying to come to some sort of an agreement acceptable to both sides.

(2/16/11)- The Food and Drug Administration (FDA) and its outside committee of cancer experts held its first public hearing since 2005 to discuss the failure of drug companies to complete follow-up studies that they promised to conduct in exchange for accelerated approval of their drugs.

The FDA can fine companies millions of dollars or even revoke approval if the follow-up studies are not completed. The six drug companies that attended the meeting cited their difficulty in enrolling patients in follow-up studies once a drug has gained approval from the FDA to be sold to the public.

"These confirmatory trials are as important- if not more important- than the initial trials leading to the accelerated approval," said Richard Pazdur, the head of the FDA's cancer division. He said some companies have taken more than 6 years to complete these follow-up studies.

The importance of this meeting was highlighted by the recent decision of the FDA that it intends to revoke the accelerated approval of the blockbuster drug Avastin for use in treating breast cancer. The FDA said follow-up studies of Avastin by its manufacturer Genetech, a unit of Roche Holding AG failed to show that the drug significantly delays the spread of tumors in breast-cancer patients. Genentech is appealing this decision.

(1/9/11)- Deputy Commissioner Joshua Sharfstein, 41 years old, the number 2 official at the Food and Drug Administration (FDA) will be leaving the agency to become the top public-health official for the state of Maryland. Dr. Sharfstein, who is both a physician and a researcher, has been with the agency 21 months.

He previously had been an aide to Rep. Henry Waxman (D., Calif.), and was public-health director for the city of Baltimore before joining the FDA. Both he and FDA Commissioner Margaret Hamburg declined to discuss his departure.

He had briefly served as acting commissioner of the FDA shortly after arriving there in March 2009, before Dr. Hamburg was appointed the commissioner. He immediately became embroiled in the controversy involving the approval by the agency of a knee replacement device from ReGen Biologics Inc., that had been approved for usage and sale in 2008 over the repeated objections of several FDA scientists and managers.

For additional information on this controversy please see our article Medical Equipment Devices and Stents-Part II of a II Part Series dated 1012/10.

After the brouhaha with that approval, the FDA said it would toughen guidelines for the abbreviated medical device approval process that the industry favored. Under that process an applicant for a medical device approval need only show that it was as good as an already approved similar medical device.

A House oversight committee headed by Darrel Issa (R., Calif.) chastised Dr.Sharfstein in a hearing last September over delays in the withdrawal of defective lots of the pain pill Motrin in 2009.

Pharmaceutical company officials have become increasingly concerned by the FDA's punishing of individual drug executives and attorneys, in addition to the drug companies over company alleged wrongdoing.

The FDA announced that it had introduced a new Web resource called FDA Basics for Industry on its fda/gov site to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process, including information that is frequently requested by industry.

(1/1/11)- The Food and Drug Administration (FDA) approved 21 new drug applications in 2010, down from 25 in 2009, and 24 in 2008. In 2007 the agency approved only 17 new drug applications.

The figures include several major biologic drugs, but please keep in mind that generic biologic drugs will be coming onstream in the coming years.

(10/2/10)- The Food and Drug Administration announced a new rule that requires companies sponsoring new drugs or medical equipment to report to the agency within 15 days after they become aware of certain safety issues, including study findings "that suggest a significant risk to study participants" and higher than expected suspect adverse reactions to the treatment.

The rule will take effect on March 28, 2011. The rule modifies the way drug companies report harmful side effects by clarifying whether adverse reactions should be reported after the first time or after more than one occurrence has taken place. Under the previous rules, drug companies submitted too much unnecessary information without the proper context.

(7/23/10)- The FDA ordered GlaxoSmithKline PLC to stop enrolling patients in a clinical trial of its diabetes drug Avandia, while the agency decides whether or not to have the drug withdrawn from the market

The trial, which compared Avandia to Takeda Pharmaceutical Co.'s diabetes drug Actos, had enrolled about 1100 patients of a targeted 16,000

Even though an FDA advisory panel voted 20-12 to keep the drug on the market with an enhanced warning on its label, the agency has not decided whether to remove the drug from the market place

Studies have indicated that the drug increases the risk of heart attack. Patients already enrolled in the clinical trial, which is known as TIDE can stay in it for now.

(7/5/10)- A recent report from Daniel R. Levinson, the inspector general of the Department of Health and Human Services, indicated that 80% of the drugs approved for sale in 2008 had trials conducted in foreign countries, and 78% of all subjects who participated in the clinical trials were enrolled at foreign sites.

Ten medicines approved in 2008 were tested entirely abroad, with not a single test patient in the U.S. The FDA inspected only 1.9% of domestic trial sites in 2008 and only 0.7% of the foreign sites.

The report found that the FDA was 16 times more likely to audit a domestic site than a foreign one. The report went on to state that the FDA was often entirely unaware that a drug trial was even taking place in a foreign country.

Federal auditors can go to a trial site only after a company submits an application to sell the drug in the U.S., but this is often many years after the trial has taken place.

(6/25/10)- The United States Department of Agriculture's (USDA) foreign certification process for organic foods is coming under increasing criticism, for many similar reasons as to why the Federal Drug Administration (FDA) is being criticized for its inability to properly regulate the quality and safety of plants manufacturing drugs overseas that are brought into this country.

The USDA's green seal of "organic" approval now is coming into question for overseas products that use private groups to conduct most organic inspections. The agency recently banned a leading American inspector from operating for it in China because of a conflict of interest, and it will send an audit team to that country to broadly review the certification process.

The banned inspector is the Organic Crop Improvement Association (OCIA) which is headquartered in Nebraska, but used employees of a Chinese government agency to inspect state controlled farms and food processing facilities. The OCIA has been a leading inspector of Chinese organic foods for the U.S. market.

The U.S. imports about $3 billion a year in farm products from China, but trade data does not break down as to how much of it is organic food. On May 28, the association signed a settlement agreement with the USDA barring it from operating in China for at least a year..

OCIA is a nonprofit organization formed by American farmers in the 1980s. According to agency records it inspects more than 1,800 operations in 11 countries, mostly in the U.S., Canada and Latin America. It had overseen 223 operations in China last year, which is about one-third of all department-approved producers in there.

OCIA joined forces with the Organic Food Development Corporation (OFDC), an agency affiliated with Chinese Ministry of Environmental Protection. Inspectors from the OFDC went out to the farms and factories, and then sent their reports to the OCIA in Nebraska.

The USDA objected to the arrangement after a 2007 audit that found this arrangement violated a rule barring certifiers from reviewing operations in which they held a commercial interest.

(3/10/10)- The Office of Criminal Investigations (OCI) is the authority within the Federal Drug Administration that is responsible for criminal prosecutions of food and drug companies for violations of the agency's regulations. It is an autonomous and independent segment within the FDA that, according to a recently released report from the Government Accountability Office, has operated without being properly monitored by the agency's top officials.

Most criminal actions brought by the OCI are for violations by companies under a provision called "strict liability". The individual officers of the offending companies are rarely prosecuted.

In a letter to Senator Charles A. Grassley (R., Iowa), the FDA said that an internal committee has recommended that the agency and the OCI "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool."

The OCI's budget rose 73% between 1999 and 2008 to $41 million, and the number of employees increased by about 40%.

In the letter to Senator Grassley, the FDA said it would increase its oversight of the OCI and make it more accountable for its actions to the top executive of the FDA.

(3/6/10)- The director of the Food and Drug Administration's Office of Generic Drugs (OGD) is leaving his job for another position at the agency. Gary Buehler will switch to the Office of Pharmaceutical Science (OPS), which oversees the generic area. Mr. Buehler had been in his present position for about 10 years.

The deputy director of the Office of Pharmaceutical Science, Keith Webber, will take over Mr. Buehler's position on a temporary basis. No reason was given by the agency for the switch.

The OGD currently has a backlog of 2,000 generic-drug applications, with more than 500 additional applications expected by the end of the year.

Under new guidelines established by the FDA, drug manufacturers will be allowed to distribute copies of medical journal articles that describe unapproved uses for drugs.

Please keep in mind that physicians have been allowed to prescribe drugs for "unapproved" usage, but this new policy will in effect encourage the drug companies to promote their medications for unapproved uses. We at therubins strongly oppose these new guidelines

(2/20/10)- The FDA has been investigating why more than 300 patients in four hospitals were over-radiated by powerful CT scans used to detect strokes. The overdoses were first discovered last year at Cedar-Sinai Medical Center in Los Angeles, where patients received up to eight times as much radiation as intended.

The errors occurred over an 18-month period of time.

The agency said it plans to hold public hearings on March 30 and 31, "to solicit input on what requirements to establish" to reduce the risk to overexposure to radiation from 3 medical imaging procedures. The procedures are:

The FDA said it would work with the Centers for Medicare and Medicaid Services to incorporate new safety practice into the accreditation process of imaging facilities and hospitals.

(2/10/10)- Under the recently unveiled budget by President Obama, the FDA's 2011 budget would remain essentially flat, increasing by $80 million to $2.43 billion. Please keep in mind that the agency received a $300 million increase last year.

This figure does not include the fees the agency collects annually from the pharmaceutical and drug device industry, and other industries to review product applications and inspect facilities.

If you include these fees, the budget request totals $3.7 billion, compared with $3.2 billion in 2010.

Pharmaceutical and food companies could face more than $250 million in new fees under the budget proposal.

(10/26/09)- The House passed legislation in July that would enhance the Food and Drug Administration's power in regards to food safety. The legislation would require the FDA to inspect food facilities more frequently, and also increase its ability to prevent, rather than react to, outbreaks of illness due to food contamination.

The Senate's Health, Education, Labor and Pensions Committee began to hold hearings on that body's legislation on this topic. One of the first witnesses before the committee was the FDA's recently appointed Commissioner Margaret Hamburg. She testified that the House version of the bill would give the FDA better access to food production records during inspections and would help fund the agency by charging food companies a registration fee of $500 a year per facility.

Even without the legislation, Dr Hamburg testified that the agency would hire350 new employees for the food program, including 125 people for field inspections.

One of the sponsors of the Senate version of the bill was Senator Richard Durbin, Democrat of Illinois. The committee chairman, Tom Harkin, Democrat of Iowa, said that he hoped to have the committee vote on the proposed bill by the end of November.

(10/909)- Before a drug can be approved by the Food and Drug Administration for usage in this country it must undergo extensive and expensive clinical trials in order to prove its efficacy and safety. Once the drug has been approved for sale, the manufacturer of the drug is not allowed to promote that drug for off-label usage.

In a complaint filed in federal court in Washington, Allergan Pharmaceuticals, the manufacturer of Botox, an anti-wrinkle medication, is suing the FDA, and also the Justice Department, which prosecutes violators of the law for violation of the company's First Amendment right to speak freely and truthfully about the benefits and risks of its medication.

"This is the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company. It's a precedent setting case," said Jeffrey N.Gibbs, a lawyer in Washington who specializes in food and drug laws.

(8/16/09)- Daniel Schultz, who headed the FDA's medical device division for the last five years stepped down. He had worked at the FDA's Center for Devices and Radiological Health for 15 years.

He had come under a great deal of internal strife within the division. This came to the forefront when a group of nine division employees wrote to the House Energy and Commerce Committee to complain that Mr. Schultz and other leaders within the department had approved devices despite formal safety and efficacy concerns raised within the division

(6/25/09)- The House Energy and Commerce Committee approved legislation that would give the FDA significantly more funding and power to police food safety.

The proposed legislation would give the agency authority to order food recalls, impose new civil penalties and require companies to follow food-safety standards. The FDA would also be required to inspect so-called high-risk food facilities at least once a year and require companies to keep detailed records that would make it easier to trace the distribution of tainted foods.

The proposed bill would require some 378,000 food facilities, including 233,000 overseas, to pay an annual registration fee of $500. The legislation exempts farms that raise meat and poultry, and other facilities regulated by the U.S. Department of Agriculture.

Henry Waxman, (Dem.-Ca.} who chaired the committee, sponsored the legislation. The House has not set a date yet to vote on the legislation

(6/21/09)- In a recent interview with the media, Dr. Margaret (Peggy) A. Hamburg, the newly named Food and Drug Administration Commissioner said she is promoting earlier safety warnings to doctors and that she intends to deal with the well publicized problems in the agency's medical device division.

"There obviously have been some problems" at the Center for Devices and Radiological Health. Dr. David Kessler, the previous FDA Commissioner has described the device center as "dysfunctional," and in a "meltdown."

Dr. Hamburg said she wants to take a "hard look" at the division's decision-making and an abbreviated regulatory approval process for devices called the 510(k) process.

(6/8/09)- The FDA announced that it would set up a task force led by Joshua Sharfstein, the agency's new principal deputy commissioner, that would recommend ways to reveal more information about FDA decisions, possibly including disclosure of now secret data about drugs and devices under study.

The goal will be to make more information available to the public about items under study by the agency, but its job is complicated by the fact that there are laws on the books such as the Federal Trade Secrets Act that require that the data be kept secret.

Again it will be a delicate balance between revealing information to the public, while at the same time keeping the data covered, to protect the interest of the drug companies and medical equipment manufacturers.

"Many people have been harmed over the last decade because the FDA has treated clinical trial results of drugs and devices as trade secrets," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such data.

The task force is to submit a written report to Dr. Margaret A. Hamburg, the agency's new commissioner within 6 months.

(5/28/09)- President Barack Obama selected Dr. Thomas R. Frieden, a 48- year-old infectious disease specialist, who is presently the New York City health commissioner as the next director of the Centers for Disease Control and Prevention. His appointment does not require Senate approval. He is expected to take office in June

Dr. Richard E. Besser, who has been the agency's chief spokesman during our recent swine flu epidemic, will return to his post as head of the agency's coordinating office for terrorism preparedness and emergency response.

Dr. Frieden has worked together with Dr. Margaret (Peggy) A. Hamburg in New York City, and many health experts are looking for joint efforts on the part of the CDC and the FDA, especially in the area of food safety.

(5/22/09)- Dr. Margaret (Peggy) A. Hamburg was sworn in as commissioner of the Food and Drug Administration on Thursday after the Senate voted unanimously on Monday night to confirm her. Dr. Hamburg, who is 53 years of age, will begin work next week at the agency. Dr. Joshua Sharfstein, who has served as acting commissioner, will become the principal deputy commissioner. To see more on Dr. Hamburg's background please see our item dated 3/17/09 below.

(5/12/09)- Dr. Margaret (Peggy) A. Hamburg should easily win confirmation from the full Senate to head the Food and Drug Administration, especially after Senator Orrin G. Hatch, Republican of Utah and Senator Richard M. Burr, Republican from North Carolina, as well as nearly all Democrats who are members of the Senate Health, Education, Labor and Pensions Committee said that they would support her nomination.

To see more on Dr. Hamburg please see our item dated 3/17/09 below.

President Barack Obama's budget proposal increased the FDA's budget by 19% starting in fiscal year 2009, including $295 million in allocated money and $215 million in additional user fees. About one half of the increase would go towards food safety efforts. This would be the agency's largest increase in history.

The budget request calls for the agency to get $2.35 billion for fiscal 2010, compared with $2.06 billion in fiscal 2009

It proposed collecting $94 million in fees from food companies, a tax that would require Congressional approval. The administration also proposed collecting $47 million in fees from makers of generic drugs to help finance the staff needed to reduce the backlog of years in generic drug applications

(5/2/09)- Dr. Donna-Bea Tillman, director of the FDA's office of device evaluation, sent an e-mail message on April 10 announcing an "all-hands meeting" to discuss the strategic direction of the device center. This type of meeting has not been held for all scientists within the device evaluation office for several years.

 Nine dissident scientists had previously signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.

To see more on this matter please see our article Medical Equipment, Devices and Stents- Part I dated

(3/17/09)-President Barack Obama has nominated a former New York City health commissioner Dr. Margaret (Peggy) A. Hamburg to lead the Food and Drug Administration. Dr. Joshua Sharfstein (39), the health commissioner of Baltimore, who led the Obama administration's transition team for the FDA will become Dr. Hamburg's chief deputy.

Many political experts are calling for the FDA to be broken into two parts, one dealing with food and the other with drugs and medical equipment. If this does occur it is expected that Dr. Hamburg would handle the food section and Dr. Sharfstein the drug section.

Dr. Hamburg, 53, was appointed as the acting health commissioner in New York City in 1991, and she became commissioner the following year. She was asked to continue in that position by the new mayor Rudolph W. Giuliani when he took office in 1994.

She was best known for developing a tuberculosis control program that was very successful. She left that position in 1997 to become assistant secretary of planning and evaluation at the federal Department of Health and Human Services. She is the daughter of Dr. David A. Hamburg, a former president of the Institute of Medicine and a longtime force in public health.

She has two teenage children and serves on the board of the Sidwell Friends School where the Obama daughters, Malia and Sasha are students.

The FDA regulates more than $1 trillion worth of consumer goods and is responsible for monitoring a third of all imported goods into this country. The agency has garnered more than its share of adverse publicity in the last few years, and that is why many are calling for breaking the agency into two parts, so that it can manage its operations in a much safer and effective manner.

(2/16/09)- Did you know that before the FDA can recall a product, that the manufacturer of the product must approve the wording of the recall notice? The public has become aware of this fact because of the contaminated peanuts from the Peanut Corporation of America that has been on the front page of the media recently.

The FDA can seize a product that it suspects is contaminated, and it can ask a federal judge for permission to recall products if a manufacturer refuses to do so, but the wording of the recall notice has to be approved by the company that manufactured the product.

The delay in the wording of the recall notice is being investigated by federal officials and President Obama has vowed to change the law in this area, so that the public safety can be better protected.

(1/25/09)- Richard Besser, 49 years old, who headed the Centers for Disease Control and Prevention's public health emergency preparedness and response functions, was named as acting director replacing Julie Gerberding. Dr. Gerberding stepped down from her position after being at the helm for 6 years.

It is not clear if Dr. Besser will be named to the position on a permanent basis. As pointed out in our item dated 12/21/08 below, the leaders of the FDA and the NIH have also stepped down, with replacements awaiting naming for those positions.

(1/14/09)- The Food and Drug Administration (FDA) approved 24 first-of-a kind drugs in 2008, compared with 18 in 2007, and 22 in 2006 and 20 in 2005. A large percentage of the budget for the agency comes from payments made by the drug companies who hope to speed up the approval process.

A standard drug-review time is 10-months, while a priority review time is 6-months, and that is given to drugs that the agency deems an advance over existing treatments.

John Jenkins, director of the agency's office of new drugs told an industry conference recently that the FDA had hired more than 800 employees recently to the drug division, but training them has taken time. The agency has a goal of making a decision on 90% of applications within the six-or 10-month time frame

The FDA missed its deadlines on 32 out of 159 drug applications through October 30, or 20% of the time. Mr. Jenkins also stated that finding enough "independent" and "qualified" experts for some of the advisory panels had become an obstacle to achieving this goal recently.

(1/11/09)- Dr. Sidney Wolfe has been appointed to a four-year term on the FDA's Drug Safety and Risk Management Committee. What makes this appointment particularly significant is that Dr. Wolfe has been a vocal critic of the agency since the early 1970s. The committee is the most significant one at the FDA in connection with evaluating the safety of drugs.

Dr. Wolfe is the head of the health group at Public Citizens, which was instrumental in pushing 16 drugs off the market and having much stricter black box warnings placed on them.

He is a graduate of Case Western Reserve Medical School in Cleveland, and a former researcher at the National Institute of Health. He is also the recipient of a MacArthur "genius" award.

(12/21/08)- FDA commissioner Dr. Andrew C. von Eschenbach announced that he would resign on Inauguration Day, January 20th 2009

Dr. Elias Zerhouni has already left his post as director of the National Institute of Health. Dr. Julie Gerberding, director of the Censers for Disease Control and Prevention, wrote in a November e-mail to her staff that she expects to leave "after the administration changes." Dr. John E. Niederhuber, director of the National Cancer Institute, is expected to surrender his post after the change of administration in Washington also.

Several names have appeared as the front runners to become the next commissioner of the FDA, who will be selected by the Health and Human Services Secretary-designate Tom Daschle.

Two of the leading critics of the agency are considered the front runners. They are Dr. Steven Nissen (60)of the Cleveland Clinic, and the Baltimore health chief Joshua Sharfstein (39), who is a pediatrician. Dr. Sharfstein is leading President-elect Barack Obama's team assessing the agency. Dr. Sharfstein made the news last year when he petitioned the FDA to ban some pediatric over-the-counter cough and cold medicines.

Dr. Robert M. Califf, a Duke University cardiologist and vice chancellor, and Dr. Alan Garber, director of the Center for Health Policy at Stanford University are also being considered according to people with knowledge of the situation.

Some women's groups and scientists are supporting Susan Wood, a former FDA official who quit in a clash with her bosses' reluctance to approve the abortion inducer known as Plan B, or the "morning after" pill.

(11/26/08)-The United States Department of Agriculture oversees the monitoring of the safety of imported meat, poultry and eggs, which constitute about 20% of all American food imports.The Food and Drug Administration (FDA) is responsible for the other 80%, including vitamins, supplements and pharmaceuticals as well as medical equipment.

In toto, about 15% of the nation's overall food supply is imported, according to the U.S. Government accountability Office. Sixty percent of fresh fruits and vegetables are imported, and three-quarters of all seafood.

The FDA opened its first office inspection station in China, at their capital in Beijing and plans to open offices in Shanghai and Guanzhou, shortly.The offices in China will include sight officials described as "inspectors and senior technical experts in foods, medicine and medical devices.

According to Michael O. Leavitt, the secretary of health and human services, the U.S. imported more than $321 billion worth of goods from China last year.

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
updated August 11, 2017

To e-mail: hrubin12@nyc.rr.com or allanrubin4@gmail.com

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