House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations
Posted 17 November 2017 | By
The US Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis.
The bill is partly the result of criticism raised over the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have been able to use for a decade.
Though earlier this year the product was obtained by the US military under an expanded access Investigational New Drug (IND) designation, according to reports.
House Armed Services Committee Chairman Mac Thornberry (R-TX) and Ranking Member Adam Smith (D-WA) said in a statement on Tuesday: “The debate over this issue has highlighted how poorly the FDA has served the needs of our troops in harm’s way, extending even to a press campaign to spin the facts and protect its slow bureaucratic processes. Waiting a decade for approval of treatments that can save lives on the battlefield when proven medical products are in use around the world is unacceptable. We believe that the attention this debate has brought to the issue has begun to change that.”
According to the language of the bill, passed alongside the NDAA, FDA would expedite the development or review of a product if the secretary of defense found that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to US military forces.
The bill also says FDA and DoD, or the Biomedical Advanced Research and Development Authority, will meet on a semi-annual basis to review relevant products in the DoD portfolio.
Peter Marks, director of the Center for Biologics Evaluation and Research, shall also meet quarterly with DoD to discuss the development status of regenerative medicine advanced therapies, blood, and vaccine medical products and projects that are the highest priorities to DoD, which “may include freeze dried plasma products and platelet alternatives,” the bill says.