WellPoint, FDA To Launch Real-Time Drug-Tracking Surveillance System To Improve Safety Monitoring

Main Category: Public Health
Also Included In: IT / Internet / E-mail;  Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 16 Apr 2008 - 10:00 PDT

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WellPoint on Tuesday in partnership with FDA plans to announce the launch of one of the first real-time medication surveillance systems, the Wall Street Journal reports. Under the system, WellPoint early next year will begin to scan the records of medical claims and medication use for more than half of the 35 million U.S. residents enrolled in company health plans to attempt to identify possible safety issues with certain treatments or combinations of treatments.

According to the Journal, the "drug safety monitoring system used by the FDA" -- which "relies largely on harried doctors and drug companies to report problems" and, according to the Government Accountability Office, identifies only 10% of adverse events --"has been spotty, slow and passive." A law enacted last year requires FDA to establish a computerized network to scan public and private health insurance and pharmacy records for safety issues with new medications. In response, FDA plans to partner with WellPoint, UnitedHealth Group and other large health insurers to "rely on their databases," and the companies, "in turn, are increasingly using their capabilities to intervene in their plan members' care," the Journal reports.

Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, said, "We're bringing together all these different groups in a network so that we can ask them to look at the same questions at the same time." Woodcock said that, in addition to WellPoint, "we need to partner with a lot of groups because they'll represent different populations."

Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said that pharmaceutical companies are "watching with a great deal of interest" (Fuhrmans, Wall Street Journal, 4/15).

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