Advisory panel rebuffs FDA risk-mgmt. plan for pain meds
The FDA has been grappling with the best way to encourage manufacturers to ensure the safety of new sustained-release and long-acting formulations of opioid products, such as OxyContin and fentanyl, in light of increasing national rates of addiction, overdose and death, especially among teens.
Many of those panelists voting “no” didn't think the proposal was strong enough, especially since it lacked a mandatory training requirement for prescribers of these drugs. Training was voluntary in a set of risk evaluation and mitigation strategies (REMS) proposed by the FDA in June. In a media briefing after the vote, Dr. John Jenkins, director of FDA's Center for Drug Evaluation and Research, described the voluntary nature of the training requirements as “one of most consistent themes we heard from members of the committee.”
However, FDA did not obligate physician training in the draft REMS, as “we were concerned about the magnitude of that program being significantly larger than we've ever instituted before” under a REMS, Jenkins said. There are 700,000-750,000 prescribers who have DEA clearance to prescribe sustained-release or long-acting opioids, and about 4 million patients receive these drugs every year.
Another reason, he said, was because of “the burden that would place on the healthcare system” if doctors would choose to opt out of a compulsory program, impacting patients' access to pain treatment.
Nevertheless, the committee spent a lot of time deliberating how it could make education obligatory for prescribers. Using its congressional REMS authority, the agency could operate through manufacturers to set up a mandatory training requirement. "It wasn't clear to us that it would be efficient [to have] manufacturers setting up a parallel system to the one that already exists," Jenkins said of why the committee nixed that idea. "Prescribers would need a DEA registration number and an opioid REMS registration."
A second possible route would be to link a training requirement to the physician DEA registration process, but that would require Congress to change legislation.