FDA to speed up review of medical products for U.S. military
November 2: The U.S. FDA today announced a memorandum of understanding with the Department of Defense to accelerate regulatory assessment of medical products for military personnel.
Congress last year passed a law to expedite regulatory review of products to diagnose, treat or prevent serious diseases or conditions facing U.S. military personnel. The memorandum establishes a framework to implement the 2017 law. It allows the Secretary of Defense to request that FDA speed up the review of investigational submissions, applications for approval/licensure, and submissions for clearance for particular medical products.
Dr. Scott Gottlieb, FDA’s commissioner, noted in a news release that the agency has already been working closely with the Defense Department to increase military personnel’s availability to medical products, especially products used to for treating battlefield injuries. For example, FDA issued an emergency use authorization earlier this year related to freeze-dried plasma, a product specifically mentioned in the 2017 law.
“Our close collaboration with DoD has helped us target and more efficiently address DoD’s immediate product priorities and foster development and review of these products in the most streamlined manner possible,” Gottlieb said. “We are looking forward to additional partnership opportunities under the [memorandum of understanding].”
Congress passed the 2017 law after controversy over a provision in the National Defense Authorization Act for fiscal year 2018 that would have allowed the Department of Defense to bypass FDA and allow the use of particular unapproved products on members of the U.S. military, according to a blog post by David Horowitz and Michael Druckman, partners at the law firm Hogan Lovells.
The increased collaboration between FDA and the military may actually prove to be good news for medical device safety, according to Madris Tomes, a former FDA analyst who is founder and CEO of medical device safety information software company Device Events.
Tomes has been concerned that the DoD’s Military Health System and the U.S. Department of Veterans Affairs don’t have regular reporting systems in place with FDA.
“This FDA and DoD collaboration is great news – especially when advances in medical products can be used to improve care for our soldiers,” Tomes said. “A successful collaboration would not only make new and effective medical products available more quickly, but would also focus on post-market surveillance so that safety data is gathered and disseminated to the FDA to improve products used stateside and even worldwide.”
Source: Medical Design & Outsourcing