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.