The US Food and Drug Administration (FDA) and the US Department of Defense (DoD) have launched a joint program to fast-track development of medical products for military personnel, akin to the FDA’s breakthrough designation program, which expedites important new products for the general population.
“The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings,” FDA Commissioner Scott Gottlieb, MD, said in a news release.
“Ensuring our nation’s war fighters have safe and effective medical products is a top priority for the agency. By standing up a collaborative program with DoD, we hope to address DoD’s immediate product priorities and ensure these products are developed and made available in the most expeditious manner possible,” Dr Gottlieb said.
The framework for the program was put in place through the bill HR 4374, which the US House of Representatives unanimously passed in November 2017 and the US Congress approved shortly thereafter, as reported by Medscape Medical News.
The bill authorized the DoD to request, and the FDA to provide, assistance to speed development and review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing US military personnel.
Unmet Needs
“We recognize that there are essential, and in some cases, unmet healthcare needs of those protecting our nation and that we at the FDA need to do our part to better protect them,” Anna Abram, FDA deputy commissioner for policy, planning, legislation, and analysis, said during a media briefing.
“Although we have had successful collaborations with DoD on some fronts, some pressing areas have clearly not received the attention from the FDA that they have needed. At its core, this new law challenges FDA to better prioritize DoD’s Office of Health Affairs medical countermeasure priorities while also affirming the importance of FDA’s role and expertise in ensuring that medical products are safe and effective,” Abram said.
Tom McCaffery, DoD acting assistant secretary of defense for health affairs, said the program was not tied to or triggered by any particular issue, incident, or crisis. “This is more about having an ongoing framework by which the DoD can identify and work with FDA in a more proactive way on products that we think will be helpful in terms of battlefield medicine and getting those products to top of the priority list.”
Terry Rauch, PhD, DoD acting deputy assistant secretary of defense, health readiness policy, and oversight, said the DoD’s top priorities are in combat casualty care. Products that the DoD is currently working on “vigorously” with the FDA include freeze-dried plasma and two platelet products ― one is cold-storage platelets, and the other is cryopreserved platelets. “These products in combat casualty care will enable us to provide acute trauma care largely in the area of stopping noncompressible hemorrhage on the battlefield,” Dr Rauch said.
The FDA and the DoD Office of Health Affairs will hold workshops in 2018 to discuss the scientific and clinical development of priority products. Following these workshops, the FDA will issue a guidance document that will help commercial product developers identify opportunities to fill unmet medical needs of the military.
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