The FDA and the Pentagon said today that they’re launching a joint program to speed the development of medical products for military personnel.
The federal safety watchdog and the Defense Dept.’s Office of Health Affairs said the program’s framework is based on a House bill passed last year that expands the FDA’s authority to approve the emergency use of unapproved medical treatments and aims to expedite the approval process. Critics claim the program could erode medical safety, putting U.S. soldiers at risk.
“Utilizing this law’s expanded authorities, the FDA will work closely with Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough designation program; provide ongoing technical advice to Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability,” the agencies said in a prepared statement.
The first phase of the program will cover blood transfusion products for the battlefield, a high priority at the Pentagon, including freeze-dried plasma, cold-stored and cryopreserved platelets. The FDA’s Center for Biologics Evaluation will spearhead that phase, FDA and DoD said.
The FDA plans to issue guidance for companies to follow in developing products based on workshops slated for this year, according to the release.
“The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings,” FDA Commissioner Dr. Scott Gottlieb said in prepared remarks. “Ensuring our nation’s warfighters have safe and effective medical products is a top priority for the agency. By standing up a collaborative program with DoD, we hope to address DoD’s immediate product priorities and ensure these products are developed and made available in the most expeditious manner possible.”
“This partnership reflects the invaluable collaboration between Health Affairs and the FDA to equip U.S. warfighters with the best possible military medical support as we work to achieve a safer, more secure world,” added acting assistant secretary of defense for health affairs Tom McCaffery. “Expeditious access to life-saving medical products for U.S. troops on the battlefield is part and parcel to ensuring our shared priority of operational readiness. The Dept. of Defense looks forward to working with the FDA on this important program to ensure delivery of critical battlefield medicine to our service members downrange.”