He’s an elected official in Washington DC, who regularly skewers this or that drugmaker with letters seeking all kinds of info. His hearings can be eventful. And his press releases don’t mince words. Who is he? If you guessed Chuck Grassley, Bart Stupak or Henry Waxman you could be forgiven. But in a piece by Congressional Quarterly about the FDA and its many woes, John Dingell, the Michigan Democrat who heads the House Energy and Commerce Committee, sounds off more than anyone else.

The agency, CQ notes, has undergone a series of congressionally mandated changes over the past two decades, often in response to problems discovered in food or drug supplies. But compared with what lawmakers are planning now, those have been fairly modest. Now, CQ writes, there is reason to believe a real overhaul is in the FDA’s future, if not this year, then perhaps in the next administration. Dingell is readying a fundamental FDA overhaul plan that, even if not enacted this year, will probably serve as a model for a Democratic White House - and possibly even a Republican one.

He would expand the FDA’s regulatory authority to the developing world by setting aside money for a team of full-time inspectors overseas; authorizing country-of-origin labeling on drugs, medical devices and food products; and levying new user fees on manufacturers to finance spot checks at overseas drug plants and at US points of entry, CQ writes. He is also holding oversight hearings to prod the agency’s political leaders to make administrative changes or face pressure to resign.

“They haven’t got the vaguest idea who’s producing these things, whether they’re safe or not, whether they’re using good manufacturing practices or not…or anything else that might relate to seeing to it that the safety of the American people is attended to,” Dingell tells CQ in typically blunt fashion. “They’ve established with great clarity that they have neither the budget nor resources. The leadership of the agency is engaged in the most diligent form of self-deceit that you can find this side of damnation.”

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