The Arthritis Foundation recently came out with its list of the top 10 arthritis events for the year 2007. This series will focus on those events.
#1: Passage of FDA Legislation on Drug Regulation and Safety
The Food and Drug Administration Amendments Act of 2007 was signed into law by President Bush in September. The result of the bill is to increase the FDA’s authority to regulate drugs. This legislation renews two programs for five years that collect fees from drug and medical device manufacturers to defray the FDA’s expense in reviewing products. The FDA’s traditionally focuses on approval of new drugs, however, Congress also used the bill expand the FDA’s powers to police drug safety.
The bill gives the FDA the power both to require drug companies to conduct additional studies to further assess the safety of medicines and to mandate new label warnings when problems become apparent. It also requires companies to publicly release results of all clinical trials that show how well their drugs performed. The FDA also gains the ability to fine drug companies for not completing follow-up studies on their drugs after they’ve received government approval. Direct-to-consumer advertisements, such as television commercials, will now be more strictly regulated by the FDA. The agency can review drug ads and fine companies for false or misleading claims, but it cannot ban them.
Two pediatric drug programs also were reauthorized for five more years as part of this legislation. The Pediatric Research Equity Act of 2007 requires a drug or biologic manufacturer that submits an application to the FDA to also submit a pediatric assessment. The Best Pharmaceuticals for Children Act of 2007 grants an additional six-months of marketing exclusivity to a manufacturer of a drug in return for pediatric use studies and reports.
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