Source: https://www.fdli.org/2018/08/update-public-law-115-92-a-new-era-of-collaboration-between-dod-and-fda/
Timestamp: 2019-04-21 16:05:26+00:00

Document:
On July 10, 2018, the U.S. Food and Drug Administration (FDA) granted the Department of Defense (DoD) an emergency use authorization (EUA) under §564 of the Food, Drug and Cosmetic Act (FDCA) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the French military (referred to in the EUA as French FDP).1 FDA’s action is significant for the medical care of the nation’s warfighters, but it may not have been possible at this time last year.
Wait, the Department of Defense Is Engaged in FDA-Regulated Medical Product Development?
Indeed, it is. DoD sends its brave men and women in uniform across the globe to fight the nation’s wars in the most austere environments and environmental conditions, often encountering significant battlefield injury and trauma, rare infectious diseases endemic to a foreign region of the world, and experiencing clinical and rehabilitative needs due to brain, extremity, or tissue damage. Accordingly, DoD is tasked with the research and development (R&D) of drugs, biologics, and devices to treat the unique needs of the warfighter to accomplish its diverse national security mission.
DoD, through the U.S. Army Medical Research and Materiel Command (USAMRMC), the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and other DoD components, has fielded revolutionary medical products that have impacted not only the warfighter, but also global health as those innovations become adopted by the general public.3 If you have heard of medical breakthroughs in infectious disease, trauma care, diagnostics, or countermeasures against chemical, biological, radiological, or nuclear (CBRN) threats, there is a high likelihood that you can trace this innovation back to DoD R&D.
How Did We Get P.L. 115-92?
FDA and other interested parties objected to this approach,6 leading to a brief legislative struggle between the agencies.7 DoD and FDA held well-reasoned positions on how best to balance the needs to eliminate the gap in the current EUA authority, prioritize DoD medical products, and protect soldiers through the objective and rigorous risk-benefit calculous required of EUA decision-making.
What Are the Features of P.L. 115-92?
Expansion of the Emergency Use Authority.
The new subsection (b) of §564 is now given two subsections. The first retains the pre-existing CBRN basis for a Secretary of Defense determination, but the second adds a completely new basis, namely, the risk of attack by “an agent or agents that that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces.” This expansion of the EUA capability for DoD is significant because the pre-existing scope of a potential DoD determination was limited to CBRN threats only. DoD medical product developers were often unable to justify an EUA request for urgently needed investigational medical treatments for battlefield trauma scenarios where there is no clear link to a CBRN threat. This gap in the EUA capability left mass casualty and battlefield trauma care options limited to expanded access IND use.
DoD Requests for Expedited Development of Military Medical Priorities.
This section covers all investigational or premarket approval or notice applications of both the FDCA for drugs and devices, and the Public Health Service act for biologics. This section requires DoD to substantiate its request for expedited development by citation of a potential for a military emergency involving a “specific and imminently life threatening risk” to the warfighter and a direct relationship between that threat and the indication for use of the product. While this text does not require that DoD be the sponsor of the regulatory application at issue, the request must come from DoD and, accordingly, there must be a relationship between DoD and (if DoD is not the sponsor) the private entity or other Federal agency sponsoring that medical product.
FDA’s Response May Offer Optimal Flexibility to Expedite Development for DoD’s Medical Priorities.
Section 1(b)(2) gives FDA the authority to bring to bear a wide range of tools to expedite development of DoD medical product priorities. In fact, FDA may use a tool not specifically enumerated in this section if appropriate to expedited development and review of DoD’s stated medical product priority. FDA’s expedited review programs—Fast Track, Breakthrough Therapy or Device, Accelerated Approval, Priority Review—involve consideration of the serious condition the product is intended to treat, the currently available therapy, and the unmet medical need.12 Here, Congress is authorizing FDA to use these expedited approval mechanisms in response to the need articulated by DoD’s request pursuant to §1(b)(1) of the statute even absent absolute compliance with the full terms of the underlying expedited review program contemplated.
Statutorily Directed Meetings between DoD and FDA.
In addition, there are two sections that direct DoD and FDA to engage in “enhanced collaboration and communication.”13 First, §(b)(3)(A) requires semi-annual meeting between DoD and FDA for “the purposes of conducting a full review of the relevant products in the Department of Defense portfolio.”14 Second, §1(b)(3)(B) requires quarterly DoD and CBER meetings “to discuss the development status of regenerative medicine advanced therapy, blood, and vaccine medical products and projects that are the highest priorities to the Department of Defense (which may include freeze dried plasma products and platelet alternatives).”15 These meetings offer the hope of long-standing communication and collaboration between DoD and FDA. In addition, this statutorily-directed communication and coordination forces both parties to improve their own end of the relationship. These provisions require DoD to communicate with a “single voice” on its most urgent medical product priorities. In addition, FDA is now forced to give appropriate and sustained attention to DoD medical product development priorities.
It is clear that DoD and FDA are working hard to implement P.L. 115-92. The two agencies will likely continue to work together to implement this statute via a formal memorandum of understanding (MOU) and it is anticipated that FDA will issue formal guidance on this new program in the future.
P.L. 115-92 has ushered in a new era of collaboration between DoD and FDA. If sustained, this collaboration and communication will yield improved battlefield medical care for our nation’s warfighters. P.L. 115-92 is a “win-win” for both DoD and FDA. This law is also a “win-win” for military medicine and global health.
U.S. Food and Drug Administration, News Release, FDA Takes Action to Support American Military Personnel by Granting an Authorization for Freeze-Dried Plasma Product to Enable Broader Access while the Agency Works Toward Approval of the Product, (July 10, 2018), available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612893.htm (last visited on July 10, 2018) [hereinafter FDA Press Release on French FDP EUA].
Pub. L. No. 115-92, 131 Stat. 2023-2025 (Dec. 12, 2017).
While the primary medical product developers within DoD are USAMRMC and JPEO-CBRND, there are other DoD components that also fund earlier stage research regulated by FDA, including the Joint Science and Technology Office of the Defense Threat Reduction Agency and the Defense Advanced Research Projects Agency. If these activities require a DoD regulatory sponsor, they would rely on the U.S. Army Surgeon’s delegation, as the Executive Agency for such activities, to USAMRMC to assume the legal risks associated with FDA sponsorship of any clinical investigation under an investigation new drug application (IND) or investigational device exemption (IDE).
716, Pub. L. 115-91, 131 Stat. 1283 at 1438-1439 (Dec. 12, 2017).
See Letter to Senator John McCain et al. from 5 Former FDA Commissioners (Nov. 9, 2017), https://cspinet.org/sites/default/files/attachment/former-commissioners-letter.pdf; see also, Laurie McGinley, Clash Over Drugs: Defense Bill would allow combat troops to use unapproved pills, devices, Washington Post (Nov. 10, 2017),https://www.pressreader.com/usa/the-washington-post/20171110/281526521335893.
See Robert King, FDA and Pentagon in turf war over product approvals,” Washington Examiner (Nov. 7, 2017), https://www.washingtonexaminer.com/fda-and-pentagon-in-turf-war-over-product-approvals; Robert Book, FDA-DoD Turf War Sheds Light on Larger Problem,” Forbes (Nov.29, 2017): https://www.forbes.com/sites/theapothecary/2017/11/29/fda-dod-turf-war-sheds-light-on-larger-problem/#23967a50d4e9; Terry Turner, Defense Bill Could bypass FDA Drug, Device Approvals,” Drug Watch (Nov. 8, 2017, modified April 17, 2018), https://www.drugwatch.com/news/2017/11/08/defense-bill-bypass-fda-drug-device-approvals/; Dan Diamond, How to Reboot the FDA, Politico: The Agenda (Dec. 13, 2017), https://www.politico.com/agenda/story/2017/12/13/fda-approval-alternatives-000593.
“REPEAL – Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.” §1(c), Pub. L. 115-92, 131 Stat. 2025 (Dec. 12, 2017).
Id. at §1(a) (emphasis added).
U.S. Food and Drug Administration, Guidance for Industry – Expedited Programs for Serious Conditions – Drugs and Biologics (2014).
1(b)(3), Pub. L. 115-92, 131 Stat. 2024 (Dec. 12, 2017).
FDA Press Release on French FDP EUA, supra, n.2.
U.S. Food and Drug Administration, Initial Work Plan for Products Relevant to the Department of Defense at p.1 (Jan. 2018), https://www.fda.gov/downloads/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMIssues/UCM592562.pdf.
U.S. Food and Drug Administration, FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel, (Jan. 16, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592581.htm.

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