May 22, 2008 -- The FDA will soon start monitoring massive amounts of Medicare’s medical records in an effort to more closely monitor drug safety under new rules set by the Bush administration, federal officials said Thursday.
The new rules will give FDA researchers access to data from Medicare’s Part D prescription drug program. The review of records is set to start next month.
Officials said the program, dubbed Sentinel, would improve the FDA’s ability to pick up potential safety problems of drugs already on the market. Currently, the agency uses a largely passive system of relying on health providers and patients to report adverse drug reactions.
“Getting enough reports to raise red flags often takes time,” Michael O. Leavitt, secretary of Health and Human Services, said Thursday. The new program, he said, is “like giving you the strongest telescope on the market.”
Under the new rules, the FDA will be able to query Medicare’s database of health information on millions of elderly and disabled Medicare beneficiaries, according to the agency. Safety officials can look for patters of side effects or adverse reactions that could tip them off to potential safety concerns, said Andrew von Eschenbach, MD, the FDA commissioner.
After a pilot period with Medicare data, officials plan to expand to program to include access to several private databases including millions more patients, they said.
But the sharing of data between two large government agencies raises questions about the privacy of personal medical information.
Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services, said the FDA will have access to medical data but not to information about the individuals they belong to.
“All of the data about personally identifiable information stays where it is, it doesn’t leave,” he said. “[The FDA] won’t ever get that information. It’ll be removed from the information they get."
Clinical trials used by drug companies to get FDA approval are often relatively small and narrowed down to selected patient groups. Epidemiologists want better monitoring of the drug reactions because many safety problems don’t show up until drugs are used by millions of patients in the diverse population.
Such was the case with the arthritis drug Vioxx, which was found to increase the risk of heart attacks and strokes. Vioxx was pulled from the U.S. market in 2004, five years after being released on the U.S. market and used by millions of patients.
Von Eschenbach said he could not speculate how much sooner the agency would have noticed Vioxx’s safety problems if it had had a program like Sentinel.
Asked if the agency would have picked up the problems more quickly, he said, “I believe … the expectation is yes.”