Drug Safety

(2/22/07)- As part of the user fee legislation that is still pending in Congress Congressman Henry Waxman and Senators Hillary Clinton and James Schumer are adding on a provision to allow an expedited FDA approval process for generic or follow-on versions of biotech drugs.

By adding on this controversial provision to the reauthorization legislation for user fees, the legislative process becomes more complicated in trying to get the user fee legislation passed. Senator Ted Kennedy has pledged his help in getting the provision enacted into law. Senate Republicans Vitter and Collins have also pledged to support the provision for generic biologics.

(2/7/07)- The Federal Drug Administration announced several new steps that it would take to try and promote drug safety. The announcement dealt with several of the recommendations found in a report that it received from the Institute of Medicine, an independent research organization.

That report criticized the FDA's handling of drug safety, citing serious structural and cultural issues. The recommendations in that report went far beyond the announcement made by the agency. It was the agency itself that had commissioned the report.

The whole drug safety issue came to the forefront as a public issue in connection with Merck's drug Vioxx. Even though Merck did remove the drug from the market in 2004, there were many indications before they did so, that the medication had some very serious negative side effects.

The new initiatives from the agency include a pilot program that will review the safety of two or three new drugs after 18 months on the market. A "report card" would be issued on the safety performance of the drug.

The agency would have a monthly online newsletter that would summarize the findings about drugs already on the market.

Congress has expressed the thought that major overhauling of the agency is required to ensure that proper drug safety matters are brought before the public.

Senator Edward Kennedy (Dem.-Mass.) and Senator Michael Enzi (Rep.-Wyo.) who are the Chairman and the ranking Republican on the Senate Health Committee have introduced legislation on drug-safety that is similar to the legislation that they proposed last year.

The bill proposes to boost FDA authority and oversight of drugs after they go on the market. "Only legislation can give the FDA the tools it needs to ensure that the agency is the gold standard for safety, " said Mr. Kennedy.

The FDA and the pharmaceutical industry are presently negotiating a new user-fee deal to provide money to pay for the safety monitoring and regulation of the advertising of drugs.

One of the items in our article on Research and Marketing of Drugs: A Challenge-Part II states- (1/15/07)- The FDA and the pharmaceutical industry have reached an agreement on the schedule for the new user fees that we discussed below in the item on 12/2/06. Congress must approve the five-year deal before it can take effect, so there probably will be some major changes before it is enacted. The FDA will start to hold public hearings on the new fee schedule next month.

Under the plan, pharmaceutical companies would pay the FDA a one-time fee on top of charges for each television ad submitted for review totaling $6.25 million in fiscal year 2008. The deal accompanies proposed legislation to renew other industry funding for FDA drug reviews through 2012. It includes about $392.8 million in fees for fiscal year 2008, but the charges for the following years were not immediately clear.

About $29.3 million of those fees would target the agency's drug safety system. The 2008 fees include an additional $4 million for technology that would eventually allow drug manufacturers to submit products electronically.

This is the process that has been in place since 1992, and there are many that question the wisdom of the FDA being funded in part by the industry that it oversees. The ad fees would allow for 27 additional staff reviewers who would evaluate the ads within 45 days

There are many who question the wisdom in the fact that the financing of the FDA comes from the industry that they regulate.


Allan Rubin
updated Februrary 22, 2007

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