Yesterday, the President signed new legislation that gives the Department of Defense (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.  The legislation was developed as an alternative to a provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have given DoD new authority to bypass FDA in authorizing certain unapproved medical products for U.S. armed forces.  The new legislation requires greater coordination and collaboration between DoD and FDA and establishes or modifies three FDA programs.

Emergency Use Authorization

First, the legislation would allow DoD to make an emergency determination in support of FDA granting an EUA, even if the source of a heightened risk to U.S. military forces does not emanate from a biological, chemical, radiological or nuclear agent, which is what current law requires.  Now the significant risk of military emergency justifying the determination could come from any source, provided that it is an “imminently life-threatening and specific risk” to U.S. military forces; and the risk need not be specifically linked to an attack but could include, for example, an endemic risk of viral contagion or other health risks associated with military deployment.  In addition, the new provision gives FDA no more than 45 days after DoD’s request to decide whether to issue the EUA.

Expedited Development and Review

Second, and perhaps more significant, the legislation requires FDA to take action to expedite the development and review of a medical product if DoD makes a qualifying request.  A qualifying request is one that is based on at least a “significant potential for a military emergency” involving a “specific and imminently life-threatening risk … of attack” to U.S. military forces.  In addition, the medical product that is the subject of a qualifying request must be “reasonably likely to diagnose, prevent, treat or mitigate” the life-threatening risk.  The statute does not expressly require the product to fulfill an “unmet medical need” to qualify for the program, as required by some other FDA programs for expedited review and development.  However, it may be hard to demonstrate the potential for an emergency with the requisite risk under the new statute if there is already a medical product approved and available to counter it.

To comply with the statutory requirement to take action to expedite the development and review of a medical product that is the subject of a qualifying request, FDA may, as appropriate, take various actions, including the following:

• Applying any applicable FDA program to expedite development and review;
• Permitting expanded access during the investigational phase, subject to applicable FDA requirements;
• Holding meetings with the sponsor throughout the development program;
• Providing “timely advice and interactive communication” to ensure that the development program is “as efficient as practicable;”
• Taking steps to ensure that the clinical trial design is as efficient as practicable, as appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment;
• Involving senior managers and an experienced review team in a collaborative, cross-disciplinary review; and
• Assigning a cross-disciplinary project lead to facilitate an efficient review and serve as a scientific liaison between the review team and sponsor.

FDA/DoD Recurrent Meetings

Third, FDA is required to meet with DoD, on a recurring basis, to facilitate enhanced collaboration and communication.  FDA must meet semi-annually with DoD and other research partners, such as HHS/BARDA, to conduct a full review of the relevant products in the DoD portfolio.  In addition, CBER must meet quarterly with DoD to discuss the highest priority projects and products for DoD, which may include freeze-dried plasma and platelet alternative products; blood and vaccines; and “regenerative medicine advanced therapies.”

Controversy

This legislation was passed in response to a controversy relating to a provision in the NDAA, which would have given DoD the authority, independent of FDA, to allow for emergency use of unapproved medical products for use by U.S. armed forces outside the U.S. to reduce harm “caused by a risk or agent of war.”  FDA and members of the House and Senate health authorizing committees opposed this armed services committee legislation and offered as an alternative the legislation that involves FDA, described above.  In addition, a bipartisan group of five former FDA Commissioners jointly wrote a letter opposing the armed services committee legislation, stating that it “likely increases the risks to for our military personnel.”  Interestingly, the armed services committee provision was included in the NDAA that was passed by both houses and also signed into law today, but the alternative bill, described above, repeals and supersedes this provision upon enactment.

The conference report for the NDAA legislation expresses the view that the traditional FDA pathways for approval and licensure of “critical medical products for combat casualty care are too slow to allow for rapid insertion and use of these products on the battlefield.”  In particular DoD and armed services committee members expressed concern about perceived delays and uncertainty associated with FDA’s review of a freeze-dried plasma product, a version of which is currently available to the military in only limited quantities under an expanded access IND.  The alternative legislation enacted specifically mentions freeze-dried plasma as a possible high priority product for DoD to discuss in the required quarterly meetings with FDA/CBER.

Implementing Guidance

There are several important undefined terms in the statute, such as “specific and imminently life-threatening risk … of attack,” for which FDA guidance will be helpful to understand the scope of these new programs.  We expect that FDA will act expeditiously to implement the new legislation, given Commissioner Gottlieb’s statement that FDA would “commit to very quickly putting in place the implementing guidance.” And we anticipate that FDA will seek to expedite the review of the freeze-dried plasma product and others that DoD may identify in the future as top priorities.  In addition, because FDA has other applicable authorities to expedite review and development, FDA’s implementing guidance might build on the newly enacted authorities to further facilitate the availability of battlefield medical products.