Grassley, Dingell Call For Overhaul Of FDA, Say Agency Should Be Able To Levy Fines, Order Recalls, Limit Drug Industry Advertising

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 31 Jul 2008 - 10:00 PDT

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Sen. Chuck Grassley (R-Iowa) and Rep. John Dingell (D-Mich.) have led an effort to restructure FDA by "giving it broad powers to levy fines, order drug recalls and restrict drug industry advertising," and a "series of crises during the past year ... have given ammunition to the lawmakers, both longtime critics" of the agency, the Wall Street Journal reports. According to the Journal, Congress likely will not "enact major changes to the agency this year because it has only a brief fall session before the November elections," but "2009 may bring the most significant overhaul at the FDA in a generation."

Grassley and Dingell have said that FDA should have the authority to recall medications and impose significant fines on pharmaceutical companies for safety violations. In addition, they have said that FDA should inspect the manufacturing facilities of generic pharmaceutical companies before they approve their products. They also have said that the next president should appoint an FDA commissioner who is independent of the industries regulated by the agency. "To lay the groundwork for their FDA overhaul," Grassley, Dingell and their supporters have ordered about 20 investigations of medications and issues related to the agency and have "directed their frustration" at FDA Commissioner Andrew von Eschenbach, who has held the position since 2006, the Journal reports.

Dingell said, "There's a total inability of the FDA to carry out its mission." According to Grassley, FDA officials "are too cozy with the companies they regulate," and new leadership must "fix the culture" at the agency.

Response
Von Eschenbach maintains that FDA officials are independent of the industries regulated by the agency and have sought to improve agency response to possible medication safety issues.

Meanwhile, the "pharmaceutical industry is digging in against changes it believes would make it harder to bring innovative drugs to market," such as increased regulation of prescription drug advertising, but "drug companies can't afford to appear too aggressive in protecting sales or deflecting stronger safety standards because that might backfire and prompt embarrassing hearings in Congress," according to the Journal. Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said, "It's an accumulation of things some companies did over the years. Now it's death by a thousand cuts," adding, "We gotta stop the bleeding" (Mundy, Wall Street Journal, 7/30).

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