Opioid makers may have a new task that’s partly old, partly new: educating prescribers on the proper use and serious risks of their medications. That’s an extension of the agency’s current requirements. The real twist? Requiring that education to include information on rival nonopioid pain therapies and alternative approaches that don’t involve drugs at all.
Commissioner Scott Gottlieb said this week that the agency plans new risk-management requirements for companies that make instant-release opioid drugs. The Risk Evaluation and Mitigation Strategy (REMS) plans that apply to extended-release formulas would be extended to the shorter-acting versions.
Those training requirements would be handled through continuing education programs, Gottlieb said. Makers of the instant-acting meds would have to provide training for doctors and other prescribers, plus pharmacists, on assessing patients’ pain, managing opioid use and recognizing addiction when it arises.
Drugmakers in the long-acting opioid field already must provide similar training, though the requirements for that education will also change. The vast majority of opioid scripts are for the short-acting kind, however; about 90%, in fact, the FDA says. “America is simply awash” in these products, Gottlieb said.
Users of short-acting meds often step up to extended-release versions that can be abused more easily—and even so-called addiction-resistant formulas are risky, Gottlieb said in a speech opening an opioid summit convened by the FDA this week.
The agency’s latest measures follow its unprecedented request that Endo pull its extended-release opioid, Opana ER, from the market. Endo complied last week, giving up almost $160 million in annual sales.
When it asked Endo to pull Opana ER, the FDA warned other drugmakers that it plans to weigh the risks and benefits of all approved opioid painkillers “and take further actions as appropriate.”
The new risk-management rules will include changes to the agency’s blueprint for that training—and here’s where the alternative treatment training comes in. The new educational outline will include “nonpharmacologic treatments for pain and pharmacologic treatments for pain (both nonopioid analgesic and opioid analgesic),” Gottlieb said.
The FDA figures that educating doctors can help reduce the number of prescriptions for opioids and shorten treatment courses for minor procedures. Those changes, in turn, would expose fewer people to the potentially addictive drugs.
For now, the REMS education would be offered but not mandatory for doctors, though the agency is considering requirements at the prescriber end, too.
Opioid manufacturers will get details on next steps soon, the commissioner promised: “[R]elevant letters, detailing the new requirements, will be sent to IR manufacturers in the coming weeks.”
In addition to the FDA press, opioid makers are defending against a slew of lawsuits, many filed by states—and some by counties and municipalities, including Chicago—that have high rates of addiction and death from opioid overdose. Most claim the drugmakers oversold the benefits and downplayed the risks in marketing the drugs to the public and doctors.