January 22, 2018

How FDA and the Pentagon are teaming up to speed approvals for some drugs and devices

Daily Briefing

    The Department of Defense (DOD) and FDA announced new steps intended to accelerate the development and review of medical products needed by U.S. military.

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    Background

    The initiative's launch follows recent debate over whether DOD should be able to approve drugs and medical devices that have not been approved by FDA for use in certain instances among military personnel.

    Proponents of giving DOD such authority say traditional pathways to FDA approval can be too slow to be quickly implemented on the battlefield. However, FDA Commissioner Scott Gottlieb has said retaining FDA's power to approve drugs and medical devices was "important because [the agency] provide[s] a level of oversight that helps ensure the safety of products" and "helps follow-up to make sure that if there are adverse events we're monitoring them."

    As part of a compromise, DOD and FDA eventually agreed to a fix for the provision, which Congress approved last year, that directs FDA to "take action to expedite the development and review of an applicable application" for certain medical products at the DOD secretary's request. The law also requires FDA officials to meet quarterly with DOD officials to discuss the military's priorities for drug and medical device reviews.

    How DOD, FDA plan to speed up approvals

    Under the new process, FDA will use its Center for Biologics Evaluation and Research (CBER) to review drugs and medical devices that DOD flags as priorities for the department in a manner similar to the way FDA reviews products in its breakthrough designation program.

    According to Politico's "Pulse," FDA will rank DOD requests on a three-level priority scale. Product reviews under the new process are expected to take about six months, as opposed to the 10 months it typically takes FDA to review products, CQ News reports. CBER Director Peter Marks said, "We don't intend to take a dramatically different approach to these products as goes to safety and efficacy than we do to any other product, it's just that we will expedite our considerations and expedite our work on them as much as we can."

    FDA and DOD also said leaders from CBER and DOD plan to meet quarterly to discuss DOD's medical priorities and hold formal meetings at least twice per year to review DOD's product development pipeline. In addition, FDA will host workshops with DOD to create guidance on facilitating the development of products DOD needs.

    According to "Pulse," one of FDA's first priorities under the new initiative will be to review cold-stored platelets, cryopreserved platelets, and freeze-dried plasma—products DOD says would help to stabilize individuals on the battlefield. Marks said FDA is committed to approving freeze-dried plasma by the end of this year, CQ News reports.

    Comments

    Tom McCaffery, principal acting assistant secretary of defense for health affairs, on Tuesday said, "The partnership we announced today reflects the invaluable collaboration between our organizations, it strengthens our ability to equip troops with the best possible medical support, and it helps us achieve our mission of providing battlefield care to support our entire military's effort to achieve a safer, more secure world." He added, "FDA's expertise and guidance will help [DOD] put the best, most effective products in the hands of battlefield medical personnel" (Clarke, Reuters, 1/16; Kheel, The Hill, 1/16; Diamond, "Pulse," Politico, 1/12; Siddons, CQ News, 1/16 [subscription required]).

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