FDA Endorses Proposed Medicare Prescription Drug Surveillance System
FDA on Monday endorsed a proposal to establish a post-market surveillance system for prescription drugs that would use billing data and health care information collected from Medicare beneficiaries, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 6/14). CMS Administrator Mark McClellan earlier this month proposed the system.
Under the proposal, CMS would collect adverse event information from Medicare beneficiaries who enroll in the new prescription drug benefit, which will begin on Jan. 1, 2006, and cross-reference the information with billing data to identify problems with medications (California Healthline, 6/6).
The proposal would cover four of 10 prescriptions written in the United States and could help CMS officials identify the most cost-effective medications, as well as problems that result from the use of treatments for off-label purposes (Los Angeles Times, 6/14). The current FDA surveillance system uses voluntary submission of reports to the Adverse Event Reporting System database. The system collects about 400,000 reports of adverse events annually but detects only 10% of serious problems (California Healthline, 6/6).
According to the Times, FDA officials "had previously been noncommittal" about the Medicare proposal. However, Janet Woodcock, the FDA's acting deputy commissioner for operations, on Monday said in a statement, "FDA strongly supports the use of data from Medicare ... to identify safety risks for recently approved medications and to learn more about real-world outcomes of medication use."
FDA and CMS officials on Monday held a public meeting in Baltimore to seek comments on the proposal from health insurers, the medical community, the pharmaceutical industry and others. At the meeting, CMS and FDA officials said that they will partner to implement the proposal. "Access to (Medicare) data will play an important role in helping FDA meet its mission," Paul Seligman, director of the FDA Office of Drug Safety, said, adding, "Medicare beneficiaries ... take more medications and more combinations of medications for longer periods than people of any other age." The proposed system will provide an "important national surveillance function that has heretofore been unavailable," Seligman said (Los Angeles Times, 6/14).
Additional information on the Medicare drug benefit is available online.