The U.S. FDA and the Department of Defense’s (DoD) Office of Health Affairs announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
“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,” says FDA Commissioner Scott Gottlieb, MD.
“Ensuring our nation’s warfighters have safe and effective medical products is a top priority for the agency,” Gottlieb adds. “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.”
The framework for the program was put in place through H.R.4374, which authorized DoD to request, and the FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel.
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; and provide ongoing technical advice to Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military.
“This partnership reflects the invaluable collaboration between Health Affairs and the FDA to equip U.S. war-fighters with the best possible military medical support as we work to achieve a safer, more secure world,” says Tom McCaffery, acting Assistant Secretary of Defense for Health Affairs.
“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,” McCaffery adds. “The Department 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.”
