FDA Given New Authority to Protect Patient Safety

The US House of Representatives has passed the Food and Drug Administration Amendments Act of 2007 (Act), which was signed into law by the President on September 27, 2007 (for a discussion of the version of the bill previously passed by the US Senate, see the earlier article in E-TIPS®, "US Congress Moves to Expand FDA Powers in Monitoring Drug Safety" Vol 5, No 24, June 6, 2007). The Act is a very broad piece of legislation, giving the Food and Drug Administration (FDA) a number of new powers aimed at improving drug safety. It also reauthorizes and expands other legislation, including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee and Modernization Act (MDUFMA) and the Best Pharmaceuticals for Children Act (BPCA). The FDA's enlarged power relates largely to post-marketing activities. For example, the Act codifies the agency's authority to compel manufacturers to conduct post-market clinical trials. It also introduces a new accelerated label revision procedure, making it easier for the FDA to issue orders to change a drug's approved label. A new "Risk Evaluation and Mitigation Strategy" (REMS) has also been created, which may be used by the FDA when it deems necessary, to assess whether a drug's benefits outweigh its risk to patient safety. This strategy applies equally to experimental and approved drugs and can include a wide range of actions, including enhanced communication efforts and restrictions on product distribution. The FDA's new powers are backed by significant penalties for violations. A manufacturer that violates its post-marketing clinical trial, labeling or REMS responsibilities could face a fine of up to US $10 million. The Act also addresses direct-to-consumer advertising, by imposing certain restrictions on advertising content, introducing fees for agency content review, and implementing fines of up to US $500,000 for making false or misleading statements. Pre-marketing efforts to increase safety are also included in the Act. For example, the government's clinical trial registry will be expanded, to now require that all ongoing trials, other than phase I trials, and their results, be submitted to the registry. Funding for these new efforts will largely be supported through the Act's reauthorization of the PDUFA and the MDUFMA, which ensures that the FDA will continue to collect funds from drug and medical device manufacturers to offset the costs of reviewing applications. This will protect a major source of the agency's revenue stream until 2012 and the Act also calls for increases in funding from industry over this 5-year period. The reauthorization of the BPCA extends a manufacturer's right to seek pediatric exclusivity for its drugs. While the Act left out certain proposed measures to tie the length of exclusivity to the annual sales of a drug, the Act introduced new time requirements for conducting pediatric studies. These requirements may make it more difficult for sponsors to obtain exclusivity. Notably absent from the Act was an approval route for bio-similar products - an issue that shows no signs of being resolved in the near future. For the text of the Act, see: http://www.thomas.gov/cgi-bin/bdquery/z?d110:h.r.03580: For commentary, see: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01708.html; http://health.cch.com/news/food-drug-devices/100207.asp; and http://tinyurl.com/2jvh7l Summary by: Michael Migus