Drug safety partnership
NEWS IN BRIEF — Posted Aug. 20, 2007
The Food and Drug Administration and the U.S. Military Health System have formed a partnership to share data on patient use of FDA-regulated drugs, biologics and medical devices in an attempt to identify trends that could provide early signals of possible harmful side effects.
General patient data, such as prescriptions, lab results and patient weight, will be available to the FDA under a joint agreement announced on Aug. 2.
The FDA has had to withdraw several popular drugs from the market in recent years when it was found that they caused health problems not detected in clinical trials.
"Currently most drug studies performed prior to FDA approval involve about 1,000 patients and follow up studies use similar numbers," said S. Ward Casscells, MD, assistant secretary of defense for health affairs. "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."
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/08/20/hlbf0820.htm.