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FDA Commissioner Says His Agency — Not Defense Department — Should Control Drug and Medical Device Approvals

FDA Commissioner Scott Gottlieb, M.D.

Washington, DC, November 8, 2017 — Rachel Roubein reports in The Hill that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., said the agency should retain control over medical device and drug approvals after a provision in the defense policy bill would give this power to the Defense Department for soldiers.

Speaking a Tuesday event on opioid prevention sponsored by The Hill and the Pharmaceutical Care Management Association. Gottlieb pointed to an alternative proposal he supports that, he said, would accelerate drug and device approvals at the FDA for the battlefield.

“That’s important because 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,” Gottlieb said.  “So, we think keeping it within the FDA context is the right thing.”

At issue is a provision of the Senate’s National Defense Authorization Act now going through conference committee.

The measure would allow the Pentagon to sign off on unapproved medical devices and drugs to be used on military personnel for emergency use, which Politico first reported Monday. Approving drugs and devices is currently the FDA’s responsibility.

Some lawmakers, and the Senate Armed Service Committee’s conference report, defend the proposal. They’ve argued that access to freeze-dried plasma for soldiers, which the Pentagon says could help save lives on the battlefield, has been difficult.

“Traditional pathways to [FDA] approval and licensure of critical medical products, like freeze dried plasma, for battlefield use are too slow to allow for rapid insertion and use of these products on the battlefield,” the report states, according to Politico.

Gottlieb said the alternative language has been shared with both chambers’ Armed Services committees and that he is willing to make modifications to this language.

“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,” Gottlieb said.

For the full story, click here.