Pentagon will not decide on battlefield drug/device approvals

The FDA will have to show that it can speed up approvals.

Controversial plans to allow the Pentagon to approve drugs and medical devices intended for use by soldiers have been set aside in the latest version of a bill approved this week by the House of Representatives.

The $692 billion fiscal 2018 National Defense Authorization Act (NDAA) contained a clause that would have given the Department of Defense (DOD) the power to greenlight “emergency use” treatments prior to FDA approval, on the grounds that it would allow potentially lifesaving treatments to be used more quickly.

The move prompted a tough response from FDA Commissioner Scott Gottlieb, M.D., however, who argued that it could leave military personnel exposed to dangerous products and that the wording of the provision meant that it could also be used to approve products not intended for battlefield use.

The bill has been passed by voice vote after negotiations between the House and Senate, with a compromise position that expands the situations for which the FDA can approve emergency use of unapproved treatments and will introduce an expedited review process. However, lawmakers said the FDA will have to make sure it acts to address the situation or will be called to account, reports The Hill.

House Armed Services Committee Chairman Mac Thornberry, R-Texas, and ranking member Adam Smith, D-Wash., said in a joint statement that “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.”

The inclusion of the clause was prompted by the DOD’s frustration over the stance taken by the FDA on freeze-dried plasma (FDP), which can be kept without freezing and reconstituted quickly during military operations but has yet to be approved by the FDA despite being used in Europe for years. The regulator has said it expects to approve FDP for armed forces' use in 2018.

“Waiting a decade for approval of treatments that can save lives on the battlefield when proven medical products are in use around the world is unacceptable,” said Thornberry and Smith, who said they would call Gottlieb to testify before the committee early next year as the latest NDAA implementation takes shape.

“To be clear, if the Armed Services Committee does not see evidence that the FDA is doing a better job meeting the needs of our troops, we will not hesitate to take action.”