House passes fix to defense bill’s medical approval provision

The House on Wednesday passed by voice vote a bill to speed up Food and Drug Administration (FDA) approval of medical devices and drugs to be used on the battlefield.

The bill is meant to address a controversial provision of the annual defense policy bill passed by the House on Tuesday that would allow the Pentagon to sign off on unapproved devices and drugs.

“Our men and women in uniform have put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield,” Energy and Commerce Committee Chairman Greg Walden (R-Ore.) said on the House floor Wednesday. “We found a good balance with our friends on the Armed Services Committee, and in working with the FDA and the leadership of the Pentagon.”

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The Pentagon and its advocates in Congress have been frustrated by the FDA’s slow approval of certain treatments they say could save lives on the battlefield. In particular, there has been a decade-long impasse between the Pentagon and the FDA over freeze-dried plasma, which the military says will help it save troops from bleeding out since it does not need refrigeration.

Because of that frustration, this year’s National Defense Authorization Act (NDAA) would allow the Pentagon to approve the use of freeze-dried plasma and other medical products to be used on the battlefield.

But the FDA and its advocates in Congress argued the language in the NDAA could open troops up to more danger because the approval process was not as rigorous as the FDA’s. They also argued the language was too broad and could allow the Pentagon to approve a range of treatments not directly related to battle.

The provision went largely unnoticed until a Politico report days before House and Senate negotiators finished work on the bill.

Wednesday’s bill, the result of a weekend compromise between the Pentagon and the FDA, expands the situations for which the FDA has authority to approve the emergency use of unapproved medical treatments and seeks to expedite the approval process.

The chairman and ranking member of the House Armed Services Committee said Tuesday they support the compromise, but pledged to call FDA Commissioner Scott Gottlieb to testify before their committee and to act if issues remain.

“Although we still have concerns about the impact it would have on our men and women in the field, we are content to let this compromise move forward in the hopes of improvement,” Reps. Mac Thornberry (R-Texas) and Adam Smith (D-Wash.) said in a joint statement Tuesday. “To be clear, if the Armed Services Committee do not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action.”

In order to try to force the Senate to pass the FDA-Pentagon compromise bill, the House will not officially send the NDAA to the upper chamber until it passes the second bill unamended.