FDA: Safety, efficacy, public health – and economy? from Mass Device

FDA officials and consumer advocates balked yesterday at legislative attempts to alter the federal watchdog agency's mission statement to include promoting job growth, competition and economic growth.

A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals would include economic obligations FDA officials said would distract from the agency's responsibility to patients.

The revision, proposed by Rep. Mike Rogers (R-Mich.), wasn't well received by FDA devices chief Dr. Jeffrey Shuren, MedPageToday reported.

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"Jobs where? Jobs for who?" Shuren asked during a House Energy & Commerce Health Subcommittee meeting. "Is that really a condition of when a device comes to market?"
This isn't Rogers' 1st attempt at making job promotion an FDA responsibility. Last year he introduced a House bill pushing the change, an effort supported by Sen. Dan Coates (R-Ind.) and his "FDA Mission Reform Act," introduced last December.

Rogers also put his name on a recent bill, co-sponsored by Rep. Ed Markey (D-Mass.), which would require medical device makers to include pediatric information in certain FDA applications, a rule that was earlier withdrawn by the FDA after the agency received "significant adverse comment" upon implementing the change in the summer of 2010.

That measure was tucked into a larger bill aimed at reauthorizing and extending the Pediatric Medical Device Safety & Improvement Act of 2007, granting device makers the ability to make profits on pediatric devices cleared under Humanitarian Device Exemption and extending a grant program for research on pediatric devices.

Markey attempted last month to squeeze his Safety of Untested & New Devices Act into the user fee bill, but the provision, which had no Republican co-sponsors, was spiked by the subcommittee, Boston.com reported. The bill would have given the FDA the power to request that companies submitting new devices catalog any recalls or safety issues in predicate devices.

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