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Congressman would revamp FDA’s mission to ‘protect jobs’

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Dan Mitchell
Dan Mitchell
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By
Dan Mitchell
Dan Mitchell
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April 19, 2012, 3:51 PM ET
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FORTUNE — Congressman Mike Rogers (R. Mich.) is a longtime critic of the Food and Drug Administration. The agency, he says, is too bureaucratic and takes far too long to approve new medical devices. The Michigan Republican’s proposed solution: to expand the FDA’s mission.

A double-take is precisely the reaction Rogers is looking for. He wrote an amendment to legislation now being debated to revise and expand the methods by which companies pay user fees to the FDA. The amendment would change agency’s mission statement so that, in addition to ensuring that drugs, medical devices, food, and cosmetics are safe and effective, the FDA would also be “promoting economic growth, innovation, competitiveness, and job creation among the industries regulated by this Act.”

Rogers, a small-government conservative, was a co-sponsor of the Repeal the Job-Killing Health Care Law Act — just in case you were wondering where he stood on health-care policy and regulation.

In February, Rogers posted a video on his YouTube channel headlined “Rogers questions FDA official about job-killing regulations.” In it, he grills the head of the agency’s device division, Jeffrey Shuren, and makes much of the fact that the National Venture Capital Association had recently issued a report indicating that 36% of venture firms planned to increase their investments in European life-sciences firms, and that 44% of them planned to boost such investments in Asia. This, Rogers said, was because of the FDA’s onerous processes and the “uncertainties” that come with the agency’s review process. The NVCA called for more streamlined approval process, but said nothing about the FDA revamping and expanding its mission to include implementing a national industrial policy.

During a hearing of the Health subcommittee of the House Energy and Commerce committee on Wednesday, Shuren registered his opposition to the amendment. “Jobs where?” he asked. “Jobs for who? Is that really a condition of when a device comes to market?”

Besides altering the very nature of the FDA’s mission, such requirements would vastly expand its duties and add to the burdens of an already massively overburdened agency, he said.

The consumer advocacy group Public Citizen sent a letter to the subcommittee complaining that the amendment “places an inappropriate emphasis on promotion of innovation by the FDA, thus undermining the agency’s primary mission of protecting the public health.”

The top three industries to donate to Rogers’ campaign committee and leadership PAC since he was first elected in 2000 are “health professionals,” “insurance,” and “pharmaceuticals/health products,” according to the Center for Responsive Politics. They have contributed a total of more than $1.6 million.

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By Dan Mitchell
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