US regulators, consumer groups and pharmaceutical manufacturers breathed a collective sigh of relief as Congress approved the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 20, just a day before FDA Commissioner Andrew von Eschenbach had warned that the agency would have to start laying-off 2,000 staff working on its Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee and Modernization Act (MDUFMA) programmes. These two initiatives account for a quarter of the FDA’s annual budget and were due to expire on September 30.

In the event, the Act was approved, reauthorising both PDUFA (raising user fees paid by drugmakers by 25% to some $400 million) and MDUFMA, plus the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act, both which were also due to expire on September 30, and Commissioner von Eschembach praised the legislators and their staff for “all their hard work on this important accomplishment.”

“These programmes are vitally important to the agency and its continuing ability to protect and promote the public health,” the Commissioner added.

Consumers Union (CU) said that the way had now been cleared for President George W Bush to sign “the most significant prescription drug safety reforms in 45 years.” There is “no question” that the FDA faces enormous resource and technical challenges, said CU senior policy analyst Bill Vaughan, adding: “while there are further safety improvements we’d like to see, this legislation is a huge step forward – probably the most important change in FDA powers since 1962.”

Jim Greenwood, chief executive of the Biotechnology Industry Organization, also welcomed the bill, saying it provides the FDA with “enhanced capacity for drug evaluation, with greater transparency and consistency and an active post-market surveillance system to better elucidate the benefits and risks of drugs and biologics.” He also applauded the steps which it takes to advance the Critical Path Initiative, which the FDA launched in March 2004 in order to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biologic or device is transformed from a discovery or “proof of concept” into a medical product.

Nothing on ad bans or follow-on biologics

However, other important issues which failed to make it to the final bill include a proposed three-year moratorium on direct-to-consumer advertising of new prescription drugs and the establishment of a regulatory pathway at the FDA for generic versions of biotechnology drugs (“follow-on biologics.”)

Congress’s decision to “do without the ad ban” was welcomed by the National Association of Broadcasters, whose executive vice president for media relations, Dennis Wharton, applauded Congress for “adopting legislation that does not sever an important information link for American consumers. Each year, thousands of Americans seek treatment for heart disease, high blood pressure and other diseases through education that comes in part from prescription drug advertising. There is simply no legitimate reason to deny American citizens this potentially life-saving information,” he said.

Nevertheless, noted Billy Tauzin, chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), the bill will enable the FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, “helping to ensure that benefits and risks are clearly and accurately communicated.” He added that it will create “strong incentives for companies to submit such advertisements to the agency before airing them, in accordance with PhRMA’s Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs.”

Mr Tauzin also welcomed the BPCA’s reauthorisation, saying that this Act had “done more to spur research and generate critical information about the use of medicines in pediatric patents than any other initiative.” By Lynne Taylor