Over the Veteran’s Day weekend, Congress was busy finalizing the National Defense Authorization Act (NDAA) for fiscal year 2018. Within that legislation is a disturbing provision that essentially allows the Department of Defense to sidestep the Food and Drug Administration.
Page 4 of the conference report “Authorizes the Assistant Secretary of Defense for Health Affairs to approve certain medical products for use by combat medics to improve chances of survival on the battlefield,” based on the recommendations of five “external advisors.” Essentially, this allows the DoD to bypass FDA approval for medications and devices used to treat injured combat personnel – without any study or scientific review.
In a letter to the Senate Armed Services Committee dated November 9, five former FDA commissioners who have served since the Bush I Administration expressed their concerns. Pointing out that the FDA has, for the past century, been charged with ensuring the safety and effectiveness of drugs and medical devices, the commissioners wrote:
“These five external advisors are not likely to have the requisite knowledge about the chemistry, manufacturing, and controls that are part of every FDA review, nor will they have access to the raw data that are part of every new product application to the FDA. They will have no authority to require post-market studies…it is unclear how they will be able to monitor post-market safety more generally.”
Like many pieces of bad legislation, this provision of the NDAA was added with good intentions. According to a U.S. Army report published over a year ago, the story began in 2010 when the Navy asked the Army Medical Command to produce freeze-dried plasma (FDP) for treating injured Special Forces personnel along the front lines.
It turns out that an FDP product produced by the French military had been in use among U.S. allies in Afghanistan and Iraq for several years. However, no such product had been approved for use by the U.S. military since the end of World War II because of concern over blood-borne pathogens. Unfortunately, attempts by a Florida-based contractor to come up with a version that could pass FDA muster were unsuccessful.
Since the situation was deemed urgent and time was of the essence, the solution was to secure an Investigational New Drug (IND) Application that would allow the Army’s Division of Regulated Activities and Compliance (DRAC) to speed up approval for the French product as an “interim solution” within 30 days – a process that normally takes up to six months.
The military’s sense of urgency is understandable, but allowing unqualified individuals with little or no background in biochemistry or medical science, and no access to or understanding of lab data, to simply bypass the FDA approval process is not a good solution. The former FDA commissioners point out that “medical innovation for these personnel is best served by utilizing the expertise and support that the FDA brings to medical product development.”
Toward that end, members of Congress on both sides of the aisle are attempting to come up with a better way for FDA reviewers and drug manufacturers to work with the DoD through the agency’s Expanded Access (Compassionate Use) Program when the military identifies the need for a specific medication or device. Whether or not this solution can be implemented before the bill is passed and sent on for Trump’s signature is not known; the conference report has already passed in the House and will be taken up by the Senate after the Thanksgiving break.