Healthy Skepticism Library item: 7228

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Publication type: news

Perrone M.
FDA Seeks Boost in Drug Company Fees: FDA Official Says Drug Safety Monitoring Should Be Funded by an Increase in Industry Fees
Yahoo Finance 2006 Nov 14
http://biz.yahoo.com/ap/061114/fda_drug_safety.html?.v=1

Abstract:

Fees paid by Merck, Pfizer and other drug companies should be increased to help pay a larger part of the Food and Drug Administration’s drug safety budget, according to a senior agency official.
FDA Deputy Commissioner Scott Gottlieb recommended late Monday that in addition to covering part of the cost of reviewing applications for new medicines, drug companies should contribute additional funds so the agency can study the drugs’ safety once they reach the market.

The proposal, which included no specific dollar figures, comes as the FDA and the pharmaceutical industry are in the midst of closed-door negotiations for a renewal of the fee structure for new drug reviews. Companies began paying such fees in 1992 and the program has been renewed every five years since.

In that time, the industry has gone from contributing 7 percent of the budget for drug reviews to 53 percent as the number and complexity of products submitted to FDA has increased. The FDA is expected to collect more than $86 million in new drug user fees in the current fiscal year that ends next Sept. 30.

In the past, these fees have mainly been used to hire additional staff to review the safety and efficacy of drugs before they are approved for marketing to the public.

In a speech at the Manhattan Institute in New York late Monday, Gottlieb proposed boosting fees to hire additional staff to monitor how patients respond to drugs after they are approved. These staffers would develop risk management plans that specify which patients face the greatest risk of having adverse reactions to certain drugs. He said these reviews could lead the agency to place restrictions on how drugs are advertised and marketed.

The FDA could also use additional funding to develop online systems that make it easier for patients and physicians to report drug safety issues. FDA estimates that only 10 percent of adverse drug events are reported to the agency.

The Pharmaceutical Research & Manufacturers of America, which represents companies like Pfizer Inc., Johnson & Johnson and Merck & Co., declined to comment.

The push to expand FDA’s drug safety operations comes two years after Merck’s Vioxx was pulled from shelves because it showed links to heart attack and stroke. A September report on the FDA’s drug approval process by the Institute of Medicine concluded that the agency needs more people and more money to keep up with the safety of drugs already on the market.

David Blumenthal, a professor at Harvard Medical School and co-author of the IOM report, says the FDA’s drug safety division has not received the same level of funding as its premarket review division.

“Part of the premise behind drug user fees was always ‘let’s get the drugs out faster and do post-market surveillance afterward,’ “ Blumenthal said. “The Institute of Medicine thought the faster part of that equation had been honored, but the post-market surveillance part had not.”

Some lawmakers have called for a restructuring of the FDA to place greater emphasis on drug safety, but Gottlieb says such an overhaul could hurt the pace of drug development.

“Some of the ideas that have been discussed in broader policy circles for improving drug safety measures will do little to make our drugs safer but will do a whole lot to limit access to needed medicines and to slow down the development of new innovations,” Gottlieb said.