FDA Backs Plan to Monitor Drug Safety Through Medicare Program

Times Staff Writer

The Food and Drug Administration on Monday endorsed an idea that experts said could greatly improve the nation’s drug safety system: using information from the forthcoming Medicare prescription benefit to spot problems with new medications.

The “FDA strongly supports the use of data from Medicare ... to identify safety risks for recently approved medications and to learn more about the real-world outcomes of medication use,” Dr. Janet Woodcock, the FDA’s acting deputy commissioner for operations, said in a statement.

The agency has recently been under fire for moving too slowly to respond to serious side effects in painkillers, antidepressants and other drugs. Lawmakers in Congress are calling for reforms to strengthen the FDA’s safety office.

Agency officials had previously been noncommittal about the Medicare idea, which originated in another corner of the federal healthcare bureaucracy -- the offices of Medicare Administrator Mark McClellan.

A former FDA chief, McClellan is interested in creating a computerized system to automatically monitor the safety and effectiveness of the medications the government will subsidize for seniors starting Jan. 1.


The FDA’s database relies on voluntary reports of problems and is estimated to miss 90% or more of serious drug reactions. But McClellan wants to take billing data from the prescription program and combine it with healthcare information already collected when doctors and hospitals submit claims for services to Medicare beneficiaries. Personal information would be removed from the files.

Computer programs could look for statistical associations between taking a prescription and medical outcomes. In theory, it could shed light on whether one type of cholesterol drug is more effective than others. It might also be able to pick up early signs that taking a medication could make some patients more susceptible to heart problems, for instance.

The system would cover four out of every 10 prescriptions written in the country. Medicare officials hope it would also identify problems resulting from the “off label” use of medications -- when doctors prescribe a drug for a medical condition that it was not originally approved to treat.

Medicare and FDA officials held a public meeting in Baltimore on Monday to gather suggestions from insurers, the medical community, the drug industry and others.

The industry has been neutral on the Medicare proposal. A spokesman for the main pharmaceutical trade group said recently that more details were needed on how the system would work. He cautioned against undermining the FDA’s regulatory authority.

At Monday’s meeting, FDA and Medicare officials said they wanted to work together. Several pilot programs are underway to study the use of Medicare data, they said.

“Access to [Medicare] data will play an important role in helping FDA meet its mission,” said Dr. Paul Seligman, head of the FDA’s Office of Drug Safety. He added that he was eager to work with Medicare.

“Medicare beneficiaries ... take more medications and more combinations of medications for longer periods than people of any other age,” Seligman said.

The data will help provide an “important national surveillance function that has heretofore been unavailable,” he said.