FDA to Further Scrutiny of Drug Risks Post-SaleMay 23, 2008 | Parker Waichman LLP
Federal Health Officials announced a major effort to use information from Medicare claims to assess the risks of drugs already on the market. This move is in response to ongoing criticism over a number of medicines that have been dangerous and, sometimes, fatal.
The new system, called “The Sentinel Initiative,” permits Food and Drug Administration (FDA) officials—for the first time—to almost immediately monitor how drugs affect health. Today, months, sometimes years, pass before officials learn of unexpected side effects. “It will be a quantum leap forward in FDA’s capacity to monitor the use of medical products that are currently on the market,” said Health and Human Services Secretary Michael O. Leavitt. With Sentinel, neither the FDA nor other researchers would have access to personal patient information.
Researchers approve the move, but worry it will take years to realize its benefits, adding that the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort challenging. “This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the FDA’s drug center, agreed that much work is still needed.
Sentinel has been in development for years. As a matter-of-fact, in 2005, Leavitt asked the FDA to explore the creation of such a system and, in 2006, the Institute of Medicine recommended one; last fall Congress voted to require the FDA to create the system.
Today, the FDA relies on doctors, patients, and manufacturers to report problems with drugs and medical devices and estimates it receives information on a fraction of such problems because where one doctor might see an infection following the use of a drug as important, another won’t. Also, today’s system is useless when a drug causes a common problem, such as Merck’s painkiller Vioxx, which was withdrawn in 2004 when a Merck study found it doubled heart risks. The FDA had no way of measuring if Vioxx caused heart problems.
Sentinel has its drawbacks though. Medicare only collects data when a doctor, hospital, or other medical provider seeks payment via a claims data form. These forms are considered much less accurate than patient health records and can point to irrelevant information. For instance, when a hospital bills Medicare for treating a patient with a heart attack, that patient may not have actually suffered a heart attack any time recently. Also, sometimes patients suffer problems after receiving drugs because they are sick, not due to the medication. And, because Medicare beneficiaries use an average of 28 prescriptions annually—compared with the national average of 13—determining which medicine caused what problem can be difficult in the elderly.
Initially, the FDA will conduct studies of established drug side effects, Woodcock said. The FDA is also speaking with private insurers about adding their records to the Sentinel system.