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Five steps to a better FDA

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FDA

Facing increasing public mistrust and growing pressure from medical device and drug makers, the FDA’s plan for improving its review processes may need some help from industry.

Device and drug makers would do well to support a bump in the FDA’s budget and a ban on advisory committee members with conflicts of interest, according to Xconomy columnist Luke Timmerman.

Industry should also get behind a ban on direct-to consumer ads, full disclosure of FDA response letters and strong regulatory science programs at business and medical schools, Timmerman wrote.

Just a day after FDA chief Dr. Margaret Hamburg released a report detailing the agency’s mission to spur innovation in medical devices, the  National Venture Capitalists Assn.’s Medical Innovation & Competitiveness Coalition unveiled its own report pointing the finger at the federal watchdog agency as the main reason device companies are fleeing the U.S. and investors are wary of opening their pocketbooks.

Surveys show that about half of respondents in the U.S. think the agency is doing a bad job. The new device pipeline is "not commensurate with the medical and public health need," Hamburg said during a conference call last week.

"Government and industry now pour $95 billion a year into biomedical R&D, and somehow society keeps getting a stagnant number of new drugs coming out the other end," Timmerman wrote. "It’s a serious concern for patients."

The FDA’s blueprint for boosting the device space includes calls for improved "consistency and clarity in the medical device review process," rebuilding its outreach offering for small businesses and focusing on developing personalized medicine.

Venture capitalists, on the other hand, blame the agency’s unpredictability for the ongoing slide in med-tech funding.

"This report confirms what has been suspected for some time, which is that venture capitalists are shifting investment capital away from lifesaving and life-sustaining products and into areas less regulated by the FDA as well as into other countries," said Dr. Beth Seidenberg, chairwoman of the MedIC coalition and a partner at Kleiner Perkins Caufield & Byers, in prepared remarks. "This trend is one that the venture industry and, we believe, the FDA, wants desperately to reverse."

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