F.D.A. PANEL OPPOSES PLAN TO TIGHTEN USE OF PAINKILLERS

An advisory committee for the Food and Drug Administration voted
overwhelmingly on Friday to reject a plan proposed by the agency to
reduce the misuse and abuse of long-acting painkillers like the drug OxyContin.

Members of the panel, which included doctors, pain experts and
others, voted 25 to 10 against the F.D.A. plan, saying they did not
think it was strong enough to control the use of such prescription
narcotics. The F.D.A. usually abides by the advice of its advisory committees.

Most panel members voted against the proposal because it did not
contain a requirement that doctors undergo training in the
appropriate use of such drugs, F.D.A. officials said.

While long-acting narcotics are critical to pain treatment, drugs
like OxyContin, fentanyl and methadone have been associated in recent
years with a national epidemic of prescription drug abuse and
addiction, as well as thousands of overdose-related deaths.

There are also growing concerns that their misuse by physicians poses
risks to patients.

Two years ago, the F.D.A. and the drug industry began working on a
plan to try to reduce the misuse and abuse of these medications. The
agency held subsequent public meetings at which interest groups like
physician groups and patient advocacy organizations expressed their
views about what the plan should look like.

Initially, F.D.A. officials had indicated that they might require
mandatory training as a condition for prescribing drugs like
OxyContin. However, when the F.D.A. announced its plan last month, it
contained a provision urging doctors to undergo voluntary training
that would be organized by the drug industry.

Even before the vote on Friday, the F.D.A. proposal had come under
criticism by some pain-management experts as being weak. And after
two days of hearings this week, F.D.A. officials received that same
feedback from its advisory panel.

"They were concerned about the voluntary nature of the training
requirements," said Dr. John K. Jenkins, the director of the office
of new drugs at the F.D.A.'s Center for Drug Evaluation and Research.

Dr. Jenkins said the F.D.A. only had the authority to direct drug
makers to provide mandatory training, adding that such a step would
involve a cumbersome and complicated process.

In addition, he said the agency was concerned that some doctors,
faced with the requirement to undergo training, would simply decide
not to prescribe the drugs and thus limit their availability to
patients who needed them.

At the moment, a doctor must only register with the Drug Enforcement
Administration to prescribe narcotic painkillers. It would be less
cumbersome to make training mandatory as a condition of such
registration, but that would require legislative action by Congress.