US Military To Help FDA Gather Safety Data

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soldiers.jpgThe FDA and the Department of Defense have formed a partnership to “share data and expertise” for reviewing and using 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 FDA says in a statement this evening.

The two agencies swear they will protect all personal health info exchanged under the agreement, in accordance with federal law. A memorandum of understanding was signed by FDA commish Andy von Eschenbach and Assistant Secretary of Defense for Health Affairs S. Ward Casscells.

The partnership is part of the FDA’s Sentinel Network, a medical product safety initiative announced in January…

…This network is supposed to explore linking private and public sector info “to create a virtual, integrated, electronic network.” Among the DoD programs involved 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 info.

“Currently, most drug studies performed prior to FDA approval involve about 1,000 patients, and follow-up studies use similar numbers,” says 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 agencies say they’ll meet later this year to establish specific procedures and safeguards. Long-range plans for the Sentinel Network call for a seamless national electronic information network that will include everything from new medical product info and patient care records to adverse event reports, and domestic and foreign clinical trials.

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