www.mapinc.org/alert/0443.html
Pubdate: Sat, 24 Jul 2010
Source: New York Times (NY)
Page: B2
Copyright: 2010 The New York Times Company
Contact:  http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Barry Meier
Bookmark: http://www.mapinc.org/find?232 (Chronic Pain)

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. 
- ---
MAP posted-by: Richard Lake