FDA will accelerate reviews for certain generic medications, Steven Galson, director of the agency Center for Drug Evaluation and Research, said on Wednesday, Reuters/Los Angeles Times reports. According to Galson, FDA will accelerate reviews for the first generic versions of brand-name medications that no longer have patent or market exclusivity protection. FDA also will accelerate reviews for generic medications that would address public health emergencies or shortages, he said. FDA currently reviews applications for generic medications in the order in which they are submitted. Galson said, "We recognize that there are certain situations under which it is advantageous to public health to expedite certain applications" (Reuters/Los Angeles Times, 10/19). FDA Deputy Commissioner Scott Gottlieb added, "Given the important role generic drugs play in public health we need to make sure the process is as efficient as possible" (Dow Jones, 10/18). Kathleen Jaeger, president of the Generic Pharmaceuticals Manufacturers Association, said that the accelerated reviews of generic medications will save the U.S. health care system millions of dollars, adding, "This action will mean that consumers will have more timely access to safe, effective and affordable generic medicines." FDA has a backlog of more than 800 generic medications that await approval, in large part because of a lack of staff and funds, according to the agency and others. Galson said, "The resource constraints combined with an increased workload in the generics program is a double whammy," adding, "Particularly in this era of tremendous importance of saving health care dollars, we just can't fall behind" (Reuters/Los Angeles Times, 10/19).

User Fees
FDA officials have said that generic pharmaceutical companies should pay user fees to the agency to accelerate reviews for their medications, and an internal agency committee has begun to consider the feasibility of the practice (Reuters/Los Angeles Times, 10/19). On Wednesday, an FDA staff member who requested anonymity said that generic pharmaceutical companies likely will begin to pay user fees in the near future. Brand-name pharmaceutical companies have paid user fees since the 1990s (Dow Jones, 10/18). Under the 1992 Prescription Drug User Fee Act, pharmaceutical companies agreed to pay user fees in exchange for reviews of new medications in 12 months or less. Pharmaceutical companies pay user fees when they file applications for new medications based on the number of manufacturing facilities that they operate and the number of products that they market in the U.S. (Kaiser Daily Health Policy Report, 10/2). Generic pharmaceutical companies have not paid user fees because their medications in most cases take less time and effort to review. However, over the past five years, the number of applications for generic medications submitted to FDA has more than doubled. Generic pharmaceutical companies "have not taken a public stance on the issue of user fees, although it's likely they would not oppose the fees if they resulted in speedier approvals," according to Dow Jones. Jaeger said, "User fees won't speed up review times if brand companies are still able to use legal loopholes to block generics from coming to market" (Dow Jones, 10/28). Critics maintain that user fees prompt FDA to act in the interest of pharmaceutical companies, rather than patients, and approve medications without adequate review (Reuters/Los Angeles Times, 10/19).

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