Statement of CSPI President Peter G. Lurie
It is beyond comprehension that congressional negotiators are poised to give the Department of Defense broad new powers to approve the emergency use of new drugs and medical devices for members of the military under certain circumstances. There already exists within the government a department with the necessary authority and experience that is statutorily charged with medical product approval: the Food and Drug Administration. The last thing we need is an Alt-FDA embedded inside the military.
For the obvious reasons, we don’t ask the Department of Health and Human Services to approve new weapons systems. And we shouldn’t ask the Department of Defense to approve new drugs or medical devices.
It is simply impossible for a five-person committee of DoD advisors to perform the product approval function to which the FDA devotes thousands of employees. Because the FDA already has an “expanded access” process for reviewing emergency uses of drugs and devices—well over 90 percent of requests for unapproved drugs are granted—adoption of this proposal could expose members of the military to dangerous and/or ineffective products. We hope that the lawmakers who are involved reconsider this inefficient and ill-considered provision.