Congress Gives New Authority to Food and Drug Administration
The Arthritis Foundation, working in coalition with several organizations, supported legislation to increase the Food and Drug Administration’s authority to regulate drugs. Recently, Congress passed the Food and Drug Administration Amendments Act of 2007 (HR 3580), which the President signed into law on September 27, 2007. The bill renews for five years two programs to collect fees from drug and medical device manufacturers to defray the FDA's expense in reviewing products seeking agency approval. While the FDA's focus traditionally has been on the approval of new drugs, its handling of drugs already on the market has earned it sharp criticism in recent years. To address these concerns, Congress used the bill as a vehicle to expand FDA's powers to police drug safety.
The bill would give the FDA the power both to require drug companies to further study the safety of medicines if needed and to mandate new label warnings, when problems do appear. It also would require companies to publicly release results of all clinical trials that show how well their drugs performed. The FDA also would gain the ability to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Direct-to-consumer ads, such as television commercials, would be more strictly regulated by the FDA. The agency would be able to review drug ads and fine companies for false or misleading ads, but it would not be able to ban them.
Two pediatric drug programs, which the AF strongly supports, also were included in this legislation. The Pediatric Research Equity Act of 2007 was reauthorized for another five years to require a manufacturer of a drug or biologic who submits an application to market a new product, new indication, new dosage form, new dosing regimen, or new route of administration to also submit a pediatric assessment. The Best Pharmaceuticals for Children Act of 2007 also reauthorized for five years grants an additional six months marketing exclusivity to a manufacturer of a drug in return for FDA-requested pediatric use studies and reports. It also includes provisions to encourage pediatric research for products that are off-patent or for products whose manufacturer declines to conduct FDA-related studies.
