FDA Reform Bill Discussed At FDLI Meeting

9 September 1997

The US Senate is now at a point where it knows where it wants to be whenit comes to Food and Drug Administration modernization legislation, according to James Hawkins, health policy advisor to the chairman of the Senate Labor and Human Resources Committee. He told those attending a Marketing and Advertising meeting sponsored by the Food and Drug Law Institute and held in Washington DC earlier this month, that though the chamber will still listen to comments, it is ready to vote.

Passage of the bill will ensure important FDA reform as well as reauthorization of the Prescription Drug User Fee Act for the full five years. There has been agreement on some important issues, including dissemination of information for off-label uses, pharmacoeconomic claims, third-party review of medical devices and the setting up of a collaborative review process to get higher quality review of medical devices, he noted.

The proposed legislation also includes some important aspects which will benefit patients directly, said Mr Hawkins, such as setting up an information data base on clinical trials, an expedited access provision, incentives for manufacturers to study drugs for pediatric uses, and requiring companies to report to the FDA on Phase IV post-marketing studies. Despite comments to the contrary, patients groups have been included in relevant discussions, he said. The bill will not get bogged down, he opined, and talk of a one-year reauthorization is counterproductive.

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