Pubdate: Fri, 04 Nov 2005
Source: Washington Post (DC)
Page: A10
Copyright: 2005 The Washington Post Company
Contact:  http://www.washingtonpost.com/
Details: http://www.mapinc.org/media/491
Author: Marc Kaufman, Washington Post Staff Writer
Bookmark: http://www.mapinc.org/find?232 (Chronic Pain)
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone)

DEA IS OPPOSED ON PAINKILLER APPROVAL

In an escalating dispute over how the government regulates powerful 
painkilling drugs, the Food and Drug Administration is seeking to 
prevent renewal of a provision that last year gave the Drug 
Enforcement Administration final say over allowing new narcotic 
medications on the market.

The FDA's deputy commissioner for medical and scientific affairs, 
Scott Gottlieb, said yesterday that the agency opposed the 
legislation, which for the second year in a row was added by the 
House to the yearly appropriations bill for several major departments. 	

"Specific language attached to the appropriations bill would 
ultimately delay access by physicians and their patients to 
important, safe and effective pain management and palliative care 
medicines," Gottlieb said. He said giving DEA authority over 
traditional FDA territory could upset "a delicate balance for 
managing both safety and access."

Although the dispute is ostensibly over a limited change in how 
controlled drugs are approved and labeled, it has become something of 
a stand-in for a larger battle over whether DEA's actions are 
intruding into the practice of medicine and denying pain sufferers 
relief they need.

Faced with what it considers to be a growing problem with diversion 
and abuse of prescription drugs, the DEA has arrested scores of 
doctors, pharmacists and other health care workers in recent years on 
charges that they improperly wrote or filled prescriptions for 
narcotic drugs such as OxyContin, Percocet and Vicodin.

The DEA initiative has alarmed pain-management specialists, and some 
are convinced that many patients are now being under-treated for pain 
as a result. They fear that the same kind of pressure the DEA exerted 
on doctors will now be exerted on the FDA.

"This is another intrusion of law enforcement into the domain of 
health care," said Scott Fishman, president of the American Academy 
of Pain Medicine and head of the Division of Pain Medicine at the 
University of California at Davis.

"The DEA has made clinicians fearful now about taking risks necessary 
to deal with the suffering of their pain patients, and this bill does 
the same to the FDA," Fishman said. "It's a subtle kind of intrusion, 
and we're afraid that the public health will suffer as a result."

The disputed provision, sponsored by Rep. Frank R. Wolf (R-Va.), was 
approved in a House-Senate conference committee last year with little 
debate and without a Senate vote. But opposition surfaced this year 
as the appropriations bill has worked its way through the conference. 
John Scofield, spokesman for the House Appropriations Committee, said 
the conference's version is not expected to be voted on until today 
at the earliest.

Wolf's spokesman, Dan Scandling, said that "some individuals and 
groups have issues with the language, but I don't understand how 
people can be against this bill.

"The goal here has always been to give law enforcement a role in how 
narcotic drugs are marketed. We saw what happened with OxyContin, and 
don't want other drugs like that to be over-marketed."

DEA's spokesmen declined to comment yesterday.

The provision, included in H.R. 2862, says no new drug containing 
controlled substances such as morphine, oxycodone and hydrocodone 
will be allowed on the market unless the DEA has "reviewed and 
provided public comments on labeling, promotion, risk management 
plans, and any other documents" related to the drug.

Before the provision was passed last year, the DEA's role with 
prescription drugs was primarily to decide how much of a controlled 
drug each company got to make, and then to monitor the use of those 
drugs on the market. Now, however, the DEA must sign off on any new 
FDA-approved medications containing controlled substances before they 
can be sold.

In its report on the bill, the House Appropriations Committee 
expressed concern that "drugs more powerful than OxyContin will be 
approved with similar risk management and labeling plans as 
OxyContin. . . . The Federal government must ensure that new 
high-risk drugs do not become easily available to illegal drug 
dealers and abusers."

The new bill gives the DEA $201 million to spend on preventing 
prescription drug diversion, an increase of more than $47 million 
from last year. 
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MAP posted-by: Richard Lake