FDA, Military Health System tighten data-sharing pact
- By Peter A. Buxbaum
- Jul 24, 2008
The Food and Drug Administration and the Military Health System (MHS) are planning to deepen an existing information-sharing relationship.
The kickoff to the new phase in the relationship came last week at a meeting attended by Rear Adm. Thomas McGinnis, chief of the TRICARE Management Activity’s Pharmaceutical Operations Directorate; Maj. Gen. Elder Granger, deputy director and program executive officer of the TRICARE Management Activity; and FDA Commissioner Dr. Andrew von Eschenbach.
Cooperation between the two agencies will be expanded to include use of MHS databases to track unexpected side effects for newly approved pharmaceuticals. It will also include investigating and tracking outbreaks of food poisonings and incidents of bioterrorism.
An existing memorandum of understanding to share information between MHS and FDA dates to July 2007 and involved sharing information regarding the review and use of FDA drugs, biologics and medical devices. FDA also has an information-sharing relationship with the Veterans Health Administration.
“FDA wants to develop algorithms to search our databases to test their suspicions about the relationships between newly approved drugs and possible side effects,” McGinnis said. “Our databases include diagnostic codes for patients and pharmaceuticals disbursed to them. Our population of patients is large enough to get to the bottom of this kind of investigation.”
MHS databases include information on more than 9 million patients, including active-duty personnel, their families and retirees.
FDA is also interested is using MHS databases for investigations of outbreaks of food-borne illnesses. “Mining our databases will allow the FDA to pinpoint hotspots around the country,” McGinnis said.
FDA will be embedding staff with MHS to train them in how FDA mines data to test its hypotheses.
“The whole point is to stay ahead of the curve,” McGinnis said. “We want to know about these situations and events before they make it into the medical literature.”
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