FDA to Get Access to Medicare Part D Data
Agency Plans to Use Medical Data to Monitor Drug Safety
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
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
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
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
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
“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
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.”