Gottlieb: Don’t take away FDA’s drug/device approval remit for soldiers

  • May 16, 2018

A new policy from the Senate’s National Defense Authorization Act, which is going through committee, would allow the Pentagon to approve devices and drugs not green-lit by FDA to be used on military personnel “for emergency use.”  The plans were first published in November 2017 by Politico.

However, Gottlieb (FDA Commissioner) has hit back at the plans, believing this should be left with his agency, as is currently the case.  “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 a The Hill event in November 2017.  “So, we think keeping it within the FDA context is the right thing.”

It had offered a plan B in which FDA would still have control; however, could see it speed up approval through talks with the Department of Defense (DOD), but this was not accepted.

Some have criticized the plans for undermining the FDA.  This issue has centered on the FDA’s rejection of freeze-dried plasma, something the Pentagon says is necessary to save the lives of military personnel.  “FDA has been working closely with DOD to bring freeze-dried plasma to our troops and anticipates that these products will be fully approved for safe and effective use for our armed forces as early as 2018,” an Agency official told Politico in November 2017.

REFERENCE:  Fierce Biotech; 07 NOV 2017; Ben Adams

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