The Los Angeles Times (7/12, Alonso-Zaldivar) reports that on a vote of 403-16, the House on Wednesday "approved a sweeping overhaul of the nation's drug-safety system, as Congress moved swiftly to send President Bush a bill that significantly improves patient protections." The House vote "followed Senate passage in May of similar legislation to strengthen the Food and Drug Administration's ability to detect risky side effects of medicines already on the market." The newly approved safety legislation "is part of a larger measure reauthorizing the collection of industry user fees that fund more than half the FDA's budget for reviewing new drugs."
The AP (7/12, Bridges) adds, "The House version would require the FDA to review the safety of certain drugs annually for the first three years following approval and then again during the seventh year. It also would require drug ads to include a toll-free number and Web address for consumers to report side effects and would permit only a single outside expert with a potential conflict of interest to be cleared to serve on any agency advisory panel."
The Wall Street Journal (7/12, A2, Mathews) reports that the FDA "would have the clear ability to order follow-up studies, restrict distribution, and enforce changes to the medications' labels." And while neither the Senate nor the House bill grants the FDA "the power to force a moratorium on direct-to-consumer advertising, a tough restriction that was discussed earlier," the agency "would be able to levy fines for false and misleading promotions." Both versions "would also force drug companies to make public information from many clinical trials." However, the Journal continues, "a key divide between the Senate and House bills" is that "the Senate will include language that creates a pathway for the FDA to approve copycat versions of biotech drugs, and the House bill doesn't address the issue." The question now "is whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will be willing to accept the move." Yesterday, the Journal notes, "Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill."
(Source: Health Law Daily, July 12, 2007)
