On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law 115-92, which was enacted in 2017. The law gives the DoD new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces; we analyzed that legislation in a blog post here.
Perhaps more significantly, FDA has chosen to build on the new law to facilitate development and FDA review of medical products with military applications that may also have broader use for general populations. In FDA’s initial Work Plan for the new law, FDA committed to issue guidance to facilitate development of medical products for “austere environments” relevant to the military. In fact, the Work Plan states that the guidance will “include information on how the approval can be expanded to the general population, when relevant. The latter is important for the ultimate availability and sustainability of the DoD medical product development enterprise.”
Under the terms of this MoU:
- DoD will develop and maintain a Medical Product Priority (MPP) List (“Priority List”) under parameters set by the MoU, and FDA will expedite the development and review of medical products on that list;
- DoD and FDA senior leadership will conduct semi-annual meetings to discuss the Priority List;
- DoD and FDA’s Center for Biologics Evaluation and Research (CBER) will hold quarterly meetings to discuss regenerative medicine advanced therapy, blood, and vaccine medical products that are on the Priority List;
- FDA agrees to facilitate DoD’s ability to field investigational medical products under a clinical trial, under an expanded access mechanism, or under an EUA; and
- FDA agrees to coordinate DoD requests to expedite the review of investigational submissions, applications for approval/licensure, and submissions/notifications for clearance of such medical products reasonably likely to address a life-threatening military emergency (or significant potential for a military emergency).
Opportunities ahead for drugs deemed valuable to the U.S. military
We believe the enhanced collaboration with DoD will create new opportunities for sponsors of products that DoD recognizes as valuable to military populations, even if the drugs are also important for the general population. In some cases this will create an opportunity to be treated as if breakthrough designation had been obtained even for drugs that might not otherwise qualify for this beneficial designation. We will be closely watching for FDA’s announcements as to guidance and anticipated public meeting(s) regarding how the enhanced FDA/DoD collaboration on medical products with military application can be expanded to help broader civilian populations.