The Food and Drug Administration Amendments Act of 2007 (FDAAA)

The Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed into law on September 27, 2007. It is one of the most comprehensive and wide-ranging revisions to the Federal Food, Drug and Cosmetic Act in the last 40 years. Among other things, it entitles the US Food and Drug Administration (FDA) to compel changes to a drug's approved labeling, impose new distribution and use restrictions, and require post-market clinical trials.

The FDAAA also reauthorizes the Prescription Drug User Fee Act (PDUFA), the Pediatric Research Equity Act, and the Best Pharmaceuticals for Children Act (BPCA), imposes new limitations on the advertising and promotion of drug products, and expands the federal government's clinical trial registry and results databank.

Several consumer advocate groups have lauded the initiative. After the bill was passed in the House of Congress, the president of Consumers Union said "it's now up to the FDA to enforce this law and make sure we get the straight story on the benefits and risks of drugs on the market." And now that it has been enacted as law, it is certain to have a profound impact on the pharmaceutical industry. Highlights of some of the major provisions of the FDAAA include:

• Significantly increased user fees - these include application, product and establishment fees. They help pay for improved drug safety monitoring and enforcement in the new drug safety authority accorded to the FDA.
• New authority to regulate drugs after approval - includes being able to require a pharmaceutical company to conduct post-market clinical trials when a serious risk with a product is suspected, requiring a company to make labeling changes, and imposing distribution and use restrictions, such as limiting distribution of a pharmaceutical to certain facilities (like hospitals), under a new procedure called a Risk Evaluation and Mitigation Strategy (REMS).
• New restrictions on advertising - the FDA can require pharmaceutical companies to submit direct-to-consumer (DTC) television advertising within 45 days prior to their dissemination. The FDA is required to issue regulations defining what constitutes "clear, conspicuous, and neutral" statements of safety information and can issue significant civil money penalties for DTC advertising messages that are false or misleading.
• Reauthorization of the BPCA - reauthorizes for five years, preserving a six-month pediatric exclusivity of certain pharmaceutical products, but with added limitations.
• Clinical trial information for other than Phase I studies, including results, will have to be submitted to the NIH registry data bank.

Since several of the provisions in the FDAAA went into effect immediately, or soon after its enactment, pharmaceutical companies must ensure their compliance in order to avoid substantial civil money penalties. This will also expedite the ability for consumers to inform themselves better with regard to the safety of their medications.