FDA chief: Keep defense medical approvals in our sphere

FDA chief: Keep defense medical approvals in our sphere
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Food and Drug Administration (FDA) Commissioner Scott Gottlieb 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.

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 at The Hill event Tuesday on opioid prevention sponsored by the Pharmaceutical Care Management Association, a trade group for pharmacy benefit managers. “So we think keeping it within the FDA context is the right thing.”

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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,” he said.

The remarks came at an event focusing on strategies to prevent the opioid epidemic.

Sen. Jeanne ShaheenCynthia (Jeanne) Jeanne ShaheenAmerica will not forget about Pastor Andrew Brunson Shaheen sidelined after skin surgery Members of Congress demand new federal gender pay audit MORE (D-N.H.) hails from a state that’s been hit particularly hard by the crisis of overdose deaths from prescription painkillers and heroin.

Shaheen said President Trump campaigned in her state, saying he would address the opioid epidemic.

Her assessment: “Unfortunately, he hasn't moved fast enough or far enough, I believe, to really make the kind of impact that we need on this kind of national health emergency.”

Trump declared the opioid epidemic a public health emergency late last month, after saying his administration was drafting the paperwork to do so two months prior. 

The move didn’t free up millions of dollars, nor did it come with a funding request to Congress. Republicans and some advocates call it a good first step. Others, Democratic lawmakers and advocates, say a robust influx of federal funds is needed for the declaration to have an impact.

Curbing the opioid crisis has “bipartisan support,” Shaheen said. “Now where the support breaks down is around the funding issues and around health care as we saw in terms of the effort to repeal the Affordable Care Act.”

Shaheen pointed to an effort from some Senate Democrats to add $45 billion over 10 years — a nod to a provision in the Senate GOP’s ObamaCare repeal bill that would have done the same — to fight the crisis, but said “I don’t think that’s going anywhere.”

“But that’s important if it’s on top of the health care that’s available,” Shaheen said.

Still, she suggested the GOP proposal to repeal and replace ObamaCare and limit Medicaid would be an even greater hit to opioid treatment.

“But if you take away the health care through the expansion of Medicaid, through the Affordable Care Act, it’s a drop in the bucket to replace that,” she said.