The mission of the Food and Drug Administration (FDA) is to protect the public health by ensuring the safety, efficacy, and security of drugs, biological products and medical devices (among other responsibilities). Pretty serious business.
Given the scope and impact of this work, there is no shortage of critics of the way the FDA carries out this mission. Everyone from pharmaceutical companies to patient advocates have something to say about the FDA review process and there have been countless efforts to alter the way the medical products reach patients (Right to Try, anyone?).
But last week a new effort to circumvent the FDA review process came to light. A provision was tucked in the legislation that grants authority for ongoing activities within the Department of Defense (DoD), called the National Defense Authorization Act (NDAA) that sought to give the Pentagon the power to approve certain medical products for use on the battlefield.
The provision was in response to a dispute between the DoD and the FDA over freeze-dried plasma, a product that has not yet been approved, but DoD argues could save the lives of military personnel who suffer severe blood loss on the battlefield.
Allowing an agency outside of FDA to approve drugs for use by its own personnel would be breathtakingly unprecedented.
Ultimately, the provision was stripped from the NDAA conference report, but not without some concessions. In return for taking out the language, both the House and Senate quickly passed legislation that expands the situations in which the FDA can approve the emergency use of an unapproved treatment, with an eye toward speeding up the approval process of medical products to be used on the battlefield.
Most people would likely admit that no government agency is perfect, but this leaves us with a number of questions. Is the FDA’s review process too slow? What amount of time allows for the agency to ensure safety and efficacy? Should one government agency have the ability to subvert or circumvent another?
There are no easy answers, but one thing that seems certain is that these efforts are likely to continue. Whether it’s from DoD, patients part of the Right to Try movement, or pharmaceutical companies wanting their product on the market faster, FDA will continue to face pressure. Congress stepped in this time to uphold FDA’s authority, but next time things could play out differently.
What other factors need to be considered in this debate? Let us know at email@example.com.