Medical Insurers and FDA Develop New Way to Track Dangerous Drugs

April 2008

In collaboration with the Food and Drug Administration (FDA), WellPoint Inc., the nation's largest medical insurer, plans to announce the launch of a real-time drug surveillance system. Beginning early next year, WellPoint will systematically scan the medical information of more than half of its 35 million members to uncover patterns in medical problems that may be tied to certain drugs.

The FDA's current drug-safety monitoring program has been slow and passive – and a source of criticism about the agency's inability to protect consumers against dangerous drugs. The system relies on doctors and drug companies to report problems and captures less than 10 percent of adverse reactions, according to the U.S. Government Accountability Office. After the 2004 withdrawal of Merck & Co.'s painkiller Vioxx and the safety controversies surrounding the diabetes medication, Avandia and the schizophrenia pill, Zyprexa, Congress passed a law requiring the FDA to establish a more comprehensive drug safety program.

The FDA plans to contract with major insurers to analyze their medical information databases. The hope is that problem drugs will be detected much sooner and reliably than is possible with the current system. WellPoint says that with the new system, they would have been aware of the heart-health risks associated with Vioxx within four months of the drug's debut.