The Food & Drug Administration (FDA) is beginning a "massive new program" to reduce overdoses, diversion, and inappropriate use of powerful opioid pain relievers, especially targeting extended-release and patch formulations of fentanyl, methadone, morphine, oxycodone, and oxymorphone. On Monday, the FDA announced it had sent letters to 16 drug companies who produce the 24 listed products informing them they would now have to create a Risk Evaluation and Management Strategy (REMS) "to ensure that the benefits of the drugs continue to outweigh the risks."
That means physicians are likely to face new procedures in prescribing the drugs, and patients are likely to face more hurdles in obtaining them, an FDA official said at a Monday press conference. But pain patients already face serious obstacles in obtaining relief. The FDA action comes in the context of a campaign by the DEA to crack down on doctors it deems to have improperly prescribed large amounts of opioid pain medication -- even though prescribing what at first glance appear to be extremely large amounts is well with standard pain relief practice. Physician's fears of being prosecuted have contributed to what pain patient advocates describe as a crisis in chronic pain relief.
"Pain patients aren't drug abusers looking for a prescription fix," said Gregory Conko, senior fellow at the Competitive Enterprise Institute, which teamed up with the Pain Relief Network last May to create the Politics of Pain campaign to fight for patients' access to sufficient pain medications. "It's a genuine tragedy that the DEA often treats them and their doctors as if they were. It's as though the agency just doesn't care whether its single-minded waging of the war on drugs imposes collateral damage."
The Politics of Pain campaign has collected personal stories from physicians and patients who have explained firsthand how difficult it can be to either offer or find sufficient treatment for pain conditions. In one video interview, Gulf War veteran James Fernandez and his wife tell their story of how he, once a robustly healthy US Marine, is now virtually confined to his home because of severe, ongoing pain that has been under-treated for years.
In another interview, Dr. Alexander DeLuca, a board-certified specialist in addiction medicine, describes the obstacles faced by a physician trying to deliver the "standard of care" called for by his own medical training. According to DeLuca, virtually no patients in the country today receive proper treatment for chronic pain.
Still, there are a lot of pain pills out there. Last year, US pharmacies dispensed 21 million prescriptions for the 24 medications listed to 3.7 million patients. "This is a very extensively used group of medications," said Dr. John Jenkins, director of the FDA's Office of New Drugs at its Center for Drug Evaluation and Research. "This will be a massive new program."
Jenkins said that abuse, misuse, and accidental overdoses involving those products had been on the rise over the last decade, and the agency is concerned about doctors inappropriately prescribing them for patients who are not suffering moderate or severe chronic pain.
"We continue to see case reports where someone with a sprained ankle receives a fetanyl patch or extended-release opioid," Jenkins said.
Dr. Bob Rappaport, director of FDA's division of anesthesia, analgesia, and rheumatology products, told the press conference the agency was also deeply concerned with the rising non-medical use of the opioids. He cited a Substance Abuse and Mental Health Services Administration (SAMHSA) report released Monday that showed some 5.2 million people said they had used prescription opioids for non-medical purposes in the past month, and that the figure among 18-to-24-year-olds had increased from 4.1% in 2002 to 4.6% in 2007.
"This is an ongoing problem, and it's getting worse," Rappaport said.
Forcing the drug manufacturers to submit REMS plans is "our attempt to ensure the benefits outweigh the risks," Jenkins said. The agency will seek to find an "appropriate balance between legitimate patient need for such drugs and the threats caused by the abuse and misuse," he added.
But tighter regulation isn't going to happen right away; a series of meetings with various stakeholders over the coming months are being set up to arrive at final regulations, said Jenkins. They will include patient advocates, health care professionals, the pharmaceutical companies, and law enforcement. The first meeting with manufacturers is set for March 3. Hopefully the concerns of patient advocates get heeded and successfully addressed, but it's not clear whether that is even possible with a venture of this nature given the current enforcement climate.