On the recordNovember 15, 2017
Our men and women in uniform have put their lives on the line for this country, and they deserve to have the earliest possible access to medical products that could save their lives on the battlefield. H.R. 4374 will establish important new authorities for the Food and Drug Administration, the FDA, and the Department of Defense, DOD, to ensure that our warfighters have the benefits of new treatments and new devices. Mr. Speaker, currently the FDA has the authority to authorize the emergency use of an unapproved medical product for a specific set of military emergencies. They have that authority. This emergency use authority requires two things, though. First, the Secretary of Defense must make a determination that there is a risk of attack on military forces with a chemical, biological, radiological, or nuclear agent. Next, the Secretary of Health and Human Services must make a declaration that there is, in fact, an emergency or threat justifying the emergency use authorization of a product. To ensure there are no unnecessary delays in this process, this legislation, H.R. 4374, establishes a deadline for the Secretary of Health and Human Services. Once the Secretary of Defense makes a declaration of an imminent risk of attack, the Secretary of Health and Human Services has 45 days--that is the maximum--to make a declaration that such a risk exists.…





