FDA, DoD collaborate on regulated drugs, biologics, and medical devices

Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulated products for all Americans.

The FDA, part of the U.S. Department of Health and Human Services, and the Department of Defense have announced a partnership to share data and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices.

General patient data such as prescriptions, lab results and patient weight will be used by the FDA to spot trends, which may identify potential concerns as well as recognize benefits of products.

The two agencies will protect all personal health information exchanged under the agreement, in accordance with federal law.

"FDA is privileged to collaborate with DoD to protect the health of all Americans," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "The opportunity to create systems to monitor the safety of products should directly benefit those cared for by the armed services as well as many others."

The partnership, which will operate under a memorandum of understanding (MOU), is part of the FDA's Sentinel Network, a medical product safety initiative first announced in January 2007. This initiative is intended to explore linking private sector and public sector information to create a virtual, integrated, electronic network. The MOU was signed by von Eschenbach and Assistant Secretary of Defense for Health Affairs S. Ward Casscells, M.D. Among the DoD programs involved in the agreement is TRICARE, the agency that administers the health care plan serving 9.1 million members of the uniformed services, retirees and their families. The first data shared will most likely be TRICARE prescription information.

"Currently, most drug studies performed prior to FDA approval involve about 1,000 patients, and follow up studies use similar numbers," said Casscells. "Data from the Military Health System will expand the possibilities to include millions of patients when it comes to follow up research. We have more than 6.6 million beneficiaries using the TRICARE pharmacy benefit alone."

The DoD and FDA will meet later this year to establish specific procedures and safeguards necessary to implement the MOU. Long range plans for the Sentinel Network call for a seamless national electronic information network that will include everything from new medical product information and patient care records to adverse event reports, and domestic and foreign clinical trials.