The Food and Drug Administration is pushing back on an attempt by Congress to give the Department of Defense the power to approve new drugs and medical devices used on the battlefield.
FDA Commissioner Scott Gottlieb said Tuesday that he is seeking an alternative to proposed language in the National Defense Authorization Act, which is being negotiated by House and Senate conference members this week. The alternative seeks to head off an agency brawl over the authority for approving new drugs used by service members.
“We think keeping it within the FDA’s context is the right thing,” Gottlieb said, at an event sponsored by The Hill newspaper.
Gottlieb said his compromise would speed approval of drugs and devices designed for troops.
“The alternative proposal would couple breakthrough therapy with expansion of FDA’s emergency use authorization,” Gottlieb said.
A breakthrough therapy designation is used to speedily approve a new product that is better than a product already on the market.
The dispute stems from the approval of freeze-dried plasma. A spokesperson for the House Armed Services Committee panel told Politico that freeze-dried plasma hasn’t been approved for 10 years.
Gottlieb said he is committed to getting freeze-dried plasma approved quickly, saying it could be done as early as next year.
This isn’t the first time the FDA and the Pentagon have clashed over approval of a product.
In 2014, the Pentagon said in a Federal Register notice it was interested in evaluating lab-developed tests that were not approved by the FDA. The notice said the department wanted to look into whether the tests could be approved by Tricare, the agency’s healthcare program.
