FDA, Policy

The Pentagon’s compromise: drug approvals to remain in FDA’s hands

The Senate has unanimously cleared an amendment to the annual defense policy bill that would allow the FDA to retain sole power to approve drugs and medical devices. The move comes just days after the bill’s policy language sparked controversy about the Pentagon usurping the FDA’s power.

As first written, the bill would have given the Pentagon authority to OK the use of experimental and unapproved drugs and medical devices for emergency use on military personnel and “individuals associated with deployed members of the armed forces.” The hope was that certain unapproved products could “reduce deaths and severity of injuries caused by agents of war.”

Scott Gottlieb

First reported by Politico, the bill’s vague language concerned congressional staff, Health and Human Services officials, and FDA Commissioner Scott Gottlieb.

The provision was sought by the DoD, in part, so it could fast-track approval of freeze-dried plasma for soldiers, which it’s thought could save the lives of soldiers on the battlefield.

The controversial language prompted negotiations between the agencies and resulted in a compromise. The new language preserves the FDA’s authority, while expediting some treatments for Pentagon needs and increasing the communication between the DoD and the FDA.

Enhanced collaboration between the agencies means the FDA will meet with the DoD twice a year to “conduct a full review of the relevant products in the Department of Defense portfolio.” The FDA will also meet quarterly with the Biomedical Advanced Research and Development Authority to discuss “the status of  regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives),” the amendment states.

Read the full text of the bill’s amendment.


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