A potentially significant shift in federal pain management and
drug control policy occurred in early November 2005. The Washington
Post reported Nov. 5, 2005 (
"Drug Enforcement Agency Stripped Of Role On New Painkillers")
that
"A House-Senate conference committee yesterday dropped a
controversial provision that gave the Drug Enforcement Administration
authority to review, and potentially block, the sale of all new
prescription narcotics. The legislation, promoted by Rep.
Frank R. Wolf (R-Va.) and attached to a multi-department
appropriations bill, passed last year with little notice.
But this year the Food and Drug Administration, many drug makers
and doctors who treat pain patients objected to renewing it,
and the provision was stripped from the bill. Opponents said the
provision was an unwarranted intrusion by a law enforcement
agency into the FDA's drug-review system. Pain specialists also
said the DEA reviews could jeopardize development of new drugs
needed by patients with chronic pain."
According to the Post,
"John Scofield, spokesman for the House Appropriations Committee,
said the provision was dropped at the request of the Senate, which did
not include it in its version of the appropriations bill. The dispute
over the measure, and the almost $50 million in additional DEA
funding attached to it, reflect a wider debate over the DEA's
proper role in monitoring the use of prescription painkillers.
The agency has arrested scores of doctors, pharmacists and other
health-care workers accused of negligence or willful diversion
in dispensing prescription narcotics that were later abused.
Pain doctors complained that, as a result, many physicians have
stopped prescribing needed painkillers."
Previously (
"DEA Is Opposed On Painkiller Approval") the Post
reported that
"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."