January 22, 2018Regulatory
The U.S. Food and Drug Administration (FDA) and the Department of Defense's (DoD) Office of Health Affairs announced today 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 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; 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 FDA outlined its approach in an initial work plan the agency developed in close collaboration with DoD. This was done in accordance with H.R.4374, which was enacted in December 2017 along with the National Defense Authorization Act for fiscal year 2018. Because current high-priority DoD product programs include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets, the initial phase of the program will be conducted among the FDA's Center for Biologics Evaluation and Research (CBER) and Health Affairs. Leadership from the FDA's CBER will meet with Health Affairs on a regular basis as part of this program, which will help the FDA's experts efficiently prioritize and expedite availability of biological products that are essential to the urgent care of those involved in national defense.
As part of this program, the FDA and Health Affairs will hold one or more workshops in 2018 to discuss aspects of the scientific and clinical development of products that are important to the health of military personnel. Findings from this workshop will inform an FDA guidance document that will help commercial product developers identify opportunities to fulfill unmet medical needs for battlefield settings and other front-line conditions experienced by men and women of the U.S. armed forces.
While the availability of certain biological products is of the upmost priority, the FDA and Health Affairs recognize that there is need for a broad range of medical products for service members, including preventive vaccines and therapeutics, and that these needs will continue to evolve in the future. Accordingly, the program is just the initial step in building an ongoing partnership between these two federal partners that can extend across the FDA's capabilities.