Administration Wants Tighter Painkiller Rules NY Times April 19, 2011
The Obama administration said on Tuesday that it would seek legislation requiring doctors to undergo training before being permitted to prescribe powerful painkillers like OxyContin, the most aggressive step taken by federal officials to control both the use and abuse of the drugs.
In the last decade, the abuse of pain medications like OxyContin has remained at epidemic levels, and medical experts have expressed concern that the legitimate use of the drugs may also pose patient risks. For years, the question of whether doctors should be trained as a condition of prescribing such medications has been fiercely debated.
Proponents of the training argue that it would help doctors better identify patients who would benefit from treatment with long-acting narcotics, and help them unmask patients feigning pain to get drugs they then abuse. Opponents say a training requirement will reduce the number of doctors prescribing pain drugs and hamper patient care.
Such a measure would probably entail Congressional approval of an amendment to the Controlled Substances Act to require that doctors undergo training as a condition of the renewal of licenses issued by the Drug Enforcement Administration for the prescription of narcotics. The law now gives the D.E.A. the authority to approve prescription licenses if a doctor merely shows an active license to practice medicine. Federal officials announced the legislative initiative on Tuesday along with outlining other measures they hope will reduce prescription drug abuse.
"The White House is absolutely committed to legislation that will make prescriber education mandatory," R. Gil Kerlikowske, President Obama's top drug policy adviser, said in an interview. "Of all the things we're proposing, this is certainly the one that's got a real bright light behind it."
Mr. Kerlikowske said his office had already approached several lawmakers about the legislation and intended to help draft it. He acknowledged that it was unclear when a bill would be submitted but said he hoped backers in Congress would do so by year's end.
Any proposal is likely to be fought by drug makers, some doctors and patient groups, who have argued that doctor training should be voluntary, not mandatory. In addition, proposed legislation would most likely encounter opposition among some lawmakers who have already mounted campaigns against what they consider to be the overregulation of the health care industry.
Among the drugs that would most probably fall under a stricter licensing measure are OxyContin, fentanyl, hydromorphone and methadone. They are considered critical to pain treatment. But they also have been associated in recent years with a national epidemic of prescription drug abuse and addiction and thousands of overdose-related deaths. OxyContin is the brand name for a long-acting form drug oxycodone. Dilaudid is the brand name for hydromorphone.
The administration's move comes after a panel of experts assembled by the Food and Drug Administration overwhelmingly rejected last year its proposal that physician training be voluntary. Those experts said that mandatory training was needed.
The F.D.A. has long argued that only Congress has the authority to mandate physician training as a condition of prescribing narcotics. That is because the legal distribution of the drugs is regulated by the Controlled Substances Act of 1970, and the licensing of doctors to prescribe them is overseen by the D.E.A., not the F.D.A.
In a related development, the F.D.A. released new regulations on Tuesday that would require the makers of long-acting or extended release painkillers to provide training to doctors but would not require doctors to take such courses. This proposal is similar to the one rejected as too weak in last year's debate. Dr. Janet Woodcock, who heads the F.D.A. Center for Drug Evaluation and Research, indicated that the new agency rules were effectively a placeholder until legislation was passed or were to be used if a relevant bill failed.
In response to a reporter's question, she said officials of the F.D.A., the D.E.A. and other federal agencies had agreed on the mandatory training requirement.
Mr. Kerlikowske, the White House drug czar, said he had sought input from doctors, medical schools and representatives of the pharmaceutical industry, which he said would pay for the training. The training would focus on opioid painkillers like OxyContin because they were the most widely abused and dangerous class of drugs prescribed by doctors, he said.
"That's where, right now, the impetus and the public concern is," he said. "You don't want to be accused of overreaching."
During the F.D.A. review, some drug makers strenuously opposed mandatory physician training. But an executive of Covidien, which sells the painkiller fentanyl, said his company supported such a requirement.
"The proposed amendment to the Controlled Substances Act giving authority to the D.E.A. to require prescriber training would be a valuable measure," said that executive, Dr. Herbert Neuman.
A spokeswoman for the maker of OxyContin, Purdue Pharma, said it also supported the approach. "The D.E.A. process to authenticate training would seem to be the best way to gain compliance," that spokeswoman, Libby Holman, stated in an e-mail.
About 600,000 doctors, dentists and physician assistants are licensed by the D.E.A. to prescribe controlled substances, according to Mr. Kerlikowske's office.
"They don't get a lot of information in their training about pain management, about addiction, about tolerance and dependence," he said.
Several other pending Congressional bills are aimed at prescription drug abuse. One of them, submitted by Representative Mary Bono Mack, Republican of California, would direct the F.D.A. to limit the approval of OxyContin and other controlled-released forms of oxycodone to the treatment of severe pain.
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