FDA Rejects Training in Painkillers for Doctors

The Food and Drug Administration, overriding the advice of an expert panel, said Monday that it would not require doctors to have special training before they could prescribe long-acting narcotic painkillers that can lead to addiction.


But the agency said companies that make the drugs, like OxyContin, fentanyl and methadone, would be required to underwrite the cost of voluntary programs aimed at teaching doctors how to best use them.

The F.D.A. announcement came after several years of deliberations by the agency into the growing problem of prescription painkiller abuse and misuse. In 2010, a panel of outside experts assembled by the F.D.A. overwhelmingly rejected the agency’s proposal that physician training be voluntary.

Instead, that panel said that mandatory training was essential both to reduce the abuse of strong painkillers, or opioids and to make sure that pain patients were treated appropriately with them.

In introducing the plan on Monday, both Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama’s top drug policy adviser, said they were hopeful that Congress would eventually enact mandatory physician training.

But the Obama administration has yet to draft legislation, despite voicing support for more than a year.

Major doctors groups like the American Medical Association have fought the idea of mandatory training, saying that the programs would be burdensome and could reduce the number of physicians who treat pain patients.

Over the last decade, overdose deaths related to the abuse and misuse of long-acting narcotics have reached epidemic proportions.

There are also growing concerns that long-term use of the drugs can cause a variety of problems, such as sharply reduced hormone production, sleep apnea and increased falls and fractures in people over 70.

Dr. Scott M. Fishman, a pain specialist, said he believed that the public health issues surrounding opioid use had reached a point at which doctor training was essential.

“The problem of prescription drug abuse has become so severe, I believe that the time has come to make that training mandatory,” said Dr. Fishman, a professor at the University of California, Davis.

Under the F.D.A. plan announced Monday, drug makers will underwrite the development of physician education programs, but the companies will not control their content, F.D.A. officials said.

Instead, groups that specialize in training programs for doctors will create the courses, which are expected to last two to three hours, the agency said.

The plan also calls for patients to receive one-page handouts about the benefits and risks of opioid use.

Dr. Hamburg, the head of the F.D.A., said the agency hoped that about 60 percent of the country’s doctors who prescribe long-acting opioids would take the educational courses within three years after the programs start.

“We are embarking on a very positive course and as physicians start to receive education,” they will respond, Dr. Hamburg said.

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