FDA Commissioner: Keep defense medical device approvals to us

A proposed provision in a new defense policy bill would allow the U.S. Department of Defense to approve medical devices and drugs, a power FDA Commissioner Scott Gottlieb, MD, argues his agency should retain, reports The Hill.

The Senate's National Defense Authorization Act would develop a regulatory pathway for the DoD to authorize emergency military uses for medical products

While supporters of the bill argue the provision is necessary to improve care for soldiers, the FDA claims establishing a new pathway is dangerous.

"We think we provide a level of oversight that helps ensure the safety of products, helps follow-up to make sure that if there are adverse events we're monitoring them, we're collecting that information," said Dr. Gottlieb, according to The Hill. "So we think keeping it within the FDA context is the right thing."

Although the FDA chief does not support the provision, he pointed to an alternative proposal to accelerate approvals through the agency for the military.

"I'm fully committed to trying to expedite products for the war fighter, and ... if they pass the language that has been put forward — the alternative language — we will commit to very quickly putting in place the implementing guidance to stand up that process," Dr. Gottlieb added.

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