The U.S. House and Senate overwhelmingly approved a broad-ranging bill designed to improve the safety of prescription drugs and to continue the FDA's drug and device user fee programs, and President Bush signed the bill into law on September 27, 2007. The “Food and Drug Administration Amendments Act” (Public Law 110-85) represents the most comprehensive overhaul of food and drug law since the Food and Drug Administration Modernization Act of 1997.
The law will: (1) reauthorize user fees for FDA approvals of drugs and devices and authorize new fees for FDA approvals of TV drug ads; (2) require some drug sponsors to conduct post-approval studies and/or clinical trials of high-risk drugs; (3) encourage development of products for children by permitting the FDA to ask for pediatric research on drugs and devices and pediatric labeling on drugs; (4) limit conflicts of interest by forbidding participation in advisory committee meetings by those with financial interests; (5) require the FDA to work with the National Institutes of Health to set up clinical trial databases that will include adverse event information and that can be searched by the public; and (6) require the FDA to establish pet food standards and to establish a registry to track all adulterated food. The law was sponsored by Representative John Dingell (D. Mich.) and Senator Edward Kennedy (D-Mass.), and it does not include provisions to permit FDA approval of generic or “follow-on” biologics, a topic considered too complicated for inclusion.
SOURCE: H.R. 3580 (as introduced), 110th Cong. 1st Sess. (2007).
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