Public Law (PL) 115-92
What is Public Law (PL) 115-92?
On December 12, 2017, the President signed into law Public Law No. 115-92 (P.L. 115-92), an Act to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by chemical, biological, radiological, or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the U.S. military forces and for other purposes. P.L. 115-92 requires enhanced collaborations and communication between the U.S. Department of Defense (DoD) and the U.S. Food and Drug Administration (FDA) on DoD's medical product priorities (MPPs) for military emergencies.
What are the features of PL 115-92?
P.L. 115-92 amended the FD&C Act to provide, among other things, specific policy for increased DoD-FDA collaboration on the development and availability of MPPs. In summary, P.L. 115-92:
- Expands FDA's emergency use authorization (EUA) authority under §564 of the FD&C Act to allow FDA to issue EUAs for emergency use of unapproved medical products or unapproved uses of approved medical products to address additional types of threats (beyond CBRN agents) related to attack with an "agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the United States military forces" (see §1(a), P.L. 115-92);
- Allows the Secretary of Defense to request, and authorizes FDA to take, specific actions to expedite the development of medical products, and the review of investigational submissions, applications for approval/licensure, and submissions/notifications for clearance for such medical products reasonably likely to diagnose, prevent, treat, or mitigate a specific and life-threatening risk to the U.S. military (see §1(b), P.L. 115-92); and
- Requires semi-annual review between DoD and FDA on DoD's MPP portfolio and requires quarterly DoD-CBER meetings for CBER-regulated MPPs (see §1(b)(3), P.L. 115-92).
How will PL 115-92 be implemented?
USAMRDC and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) have been working with the office of the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight (DASD(HRP&O)) to implement P.L. 115-92. The main features of this implementation are:
- A Memorandum of Understanding (MOU) between DoD and FDA to implement the new collaboration was signed on November 2, 2018. This MOU was negotiated by the Commissioner of Food and Drugs and the Principal Deputy Assistant Secretary of Defense for Health Affairs (PDASD(HA)) with the assistance of our legal and regulatory teams.
- The Medical Product Acceleration Committee (MPAC) has been informally established to manage the creation and maintenance of the DoD Priority List of MPPs that will be communicated to FDA, via the Assistant Secretary of Defense for Health Affairs (ASD(HA)), at the Semi-Annual and CBER Quarterly meetings required by the statute. The MPAC is intended to serve as the DoD enterprise-wide forum for discussions on which products are identified as DoD MPPs for the Priority List. The MPAC aims to achieve a DoD "one voice" approach envisioned by the statute.
What will be the impact on DoD Medical Product Development?
P.L. 115-92 has already significantly benefited DoD medical product development. The recent EUA for French Freeze Dried Plasma, the FDA approval of tafenoquine for the prevention of severe malaria, and the approval the atropine autoinjector for the treatment of chemical nerve agent poisoning, among other examples, are all fruits of this new collaboration. We expect this statute to expedite review and approval of DoD medical products and enhance DoD-FDA collaboration. Future success will depend on (i) the level of coordination and communication horizontally across the DoD enterprise, and (ii) the clarity with which DoD speaks with "one voice" to FDA.
For DoD Collaborators
In order to accomplish our product development mission, USAMRDC relies on our private collaborators to a large degree. For potential collaborators interested in the potential benefits of PL 115-92 for your product idea, please review the helpful resources on this page. Primarily, we look for submissions to our New Product Ideas portal and encourage collaborators to read the helpful, Doing Business with USAMRDC manual, which provides an overview of how collaborations are formed and how business opportunities are communicated. In addition, companies considering partnering with us may contact us for further information.
Please note that questions about DoD's process for creating the DoD Priority List, evaluating potential products useful to DoD or their placement on the Priority List, or beginning a DoD collaboration are not questions for FDA. FDA will be unable to answer these questions. The most efficient mechanisms for answering your questions are available to you on this page.
If you have questions or have interest in ensuring your product solution is given due MPAC consideration for placement on the DoD Priority List, please send an email to: USArmy.Detrick.MEDCOM-USAMRMC.List.SJA-PLemail@example.com
- FDA Webpage on PL 115-92
- U.S. Army Medical Materiel Development Activity
- U.S. Army Medical Research and Development Command Office of Regulated Activities
- Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense
- Fort Detrick Office of the Staff Judge Advocate
- Office of the Assistant Secretary of Defense for Health Affairs
- Office of the Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight
- Full Text of Public Law 115-92 (PDF 205 KB)
- Memorandum of Understanding Concerning Coordination with the Food and Drug Administration Regarding Department of Defense Medical Product Development and Assessment (PDF 5.6 MB)
- Exhibit B from MOU: Model Authorization For FDA to Share Non-Public Information with the Department of Defense (PDF 491 KB)
- Public Law 115-92: A New Era of Collaboration between DoD and FDA1
1 Reprinted with the permission of the Food and Drug Law Institute (FDLI) from the August/September 2018 issue of FDLI's Update magazine