A joint program launched by the FDA and Department of Defense (DoD) on Tuesday will prioritize the development of medical products that can help save the lives of military personnel.
Using expanded authorities granted under a provision of the fiscal year 2017 National Defense Authorization Act, the program will enable the DoD to request FDA assistance in expediting the development of products to diagnose, treat and prevent life-threatening illnesses, injuries or conditions.
“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 Scott Gottlieb said. “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.”
The FDA and the DoD Office of Health Affairs will collaborate to help better understand the medical needs of military personnel, and to expedite reviews of high-priority products. The program’s framework will resemble the FDA’s breakthrough therapy designation for high-priority drugs.
“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,” Tom McCaffery, the acting assistant secretary of defense for health affairs, said. “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 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.”
A series of workshops will be held in 2018 under the program to explore the scientific and clinical development of medical products with significance to military personnel. FDA will use feedback from the workshops to draft guidance to help commercial product developers meet needs.
“This enhanced collaboration will enable the agency to gain a better understanding of the health needs of those protecting our country while ensuring that the medical products made available to our service members are safe and effective,” Anna Abram, the deputy commissioner for policy, planning, legislation and analysis at FDA, said. “The initial program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s warfighters.”