The US Food and Drug Administration and the Department of Defense have announced a partnership under which they will share data and expertise related to the review and use of FDA-regulated drugs, biological products 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 recognise the benefits of individual products, they say.
The partnership, which will operate under a memorandum of understanding (MoU), is part of the FDA’s Sentinel Network, a medical product safety initiative announced in January 2007 to explore ways to link private- and public-sector information to create a virtual, integrated electronic network.
Among the DoD programmes 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.
FDA Commissioner Andrew von Eschenbach said the agency was “privileged to collaborate with DoD to protect the health of all Americans. 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,” he noted. Assistant Secretary of Defense for Health Affairs, Ward Casscells, pointed out that, at present, most drug studies performed prior to FDA approval involve about 1,000 patients and that follow-up studies use similar numbers. “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,” said Dr Casscells.
The DoD and FDA will meet later this year to establish specific procedures and safeguards for the MoU. Long-range plans for the Sentinel Network are 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 clinical trials carried out both in the USA and overseas, say the two agencies, which emphasise that they will protect all personal health information exchanged under the agreement, in accordance with federal law. By Lynne Taylor