Candidates with the potential to diagnose, treat or prevent serious or life-threatening disease in military personnel will get accelerated approvals.
The U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs have implemented a joint program for the development of drugs and medical devices designed to address life-threatening illnesses and injuries of military personnel. The program is founded in H.R.4374, enacted in December 2017, along with the National Defense Authorization Act for fiscal year 2018. This authorizes DoD to request—and the FDA to provide—assistance in expediting the development and review of products to diagnose, treat, or prevent serious conditions for troops.
As part of the program, FDA will work closely with Health Affairs to gain a better understanding of the specific needs of deployed personnel. Medical products that meet these needs will be given priority review similar to that granted under the agency’s breakthrough therapy designation. FDA will also provide technical advice to Health Affairs with regard to accelerating the development and manufacturing of medical products.
The program will be led by FDA’s Center for Biologics Evaluation and Research (CBER) and Health Affairs. It will initially focus on high-priority DoD product programs including freeze-dried plasma, cold-stored platelets, and cryopreserved platelets. At least one workshop will be held to discuss these topics, and the findings will be shared with the pharmaceutical industry so that drug manufacturers can understand the unmet medical needs in a battlefield setting and other front-line conditions.
“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,” said Anna Abram, the FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis. “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.”
The program is the first step in building an ongoing partnership between the FDA and the DoD. The agencies believe that this initial phase will lead to a “robust program that can better serve the health care needs of American military personnel.”