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.