FDA works with US health insurers to identify drug problems

doi:10.1136/bmj.39559.404560.DB

BMJ 2008;336:913 (26 April), doi:10.1136/bmj.39559.404560.DB

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FDA works with US health insurers to identify drug problems

Janice Hopkins Tanne

¹ New York

The first 150 words of the full text of this article appear below.

The US Food and Drug Administration is joining with health insurancecompanies to try to identify adverse drug events faster.

At present the FDA relies on voluntary reporting of problemsby doctors, drug companies, and the public.

Doctors and patients have been calling for a better reportingsystem after well publicised problems with some drugs, suchas rofecoxib (Vioxx), which was withdrawn in September 2004(BMJ 2004;329:816; doi: 10.1136/bmj.329.7470.816-a); rosiglitazone(Avandia); and antidepressants in children and teenagers.

Health insurance companies, such as Wellpoint, which insuresabout 35 million people, and UnitedHealth, another large healthinsurer, will work with the FDA. They will develop monitoringprogrammes to discover safety risks, such as unusual numbersof cardiovascular events among people taking a drug. The systemwill scan the insurance companies’ huge databases of prescriptionscollected and medical claims filed. Patients’ identitieswill be removed.

James Gavin, a spokesperson for Wellpoint, told . . . [Full text of this article]

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