FDA to expand REMS for opioids in effort to slow epidemic
- The Food and Drug Administration plans to take further steps to address the opioid addiction epidemic, announcing it would update its existing Risk Evaluation and Mitigation Strategy (REMS) requirements for the prescription painkillers.
- Calling the addiction and overdose crisis the "toughest public health challenge" faced by the FDA, agency chief Scott Gottlieb said this week current REMS requirements on extended-release opioid analgesics would be extended to manufacturers of immediate-release opioids. Letters detailing the switch will be sent to drugmakers in the coming weeks.
- The new REMS will update prescriber education on appropriate prescribing, pain management and use disorders. That training will also be extended to nurses and pharmacists. Finally, the FDA will also continue to review abuse-deterrent formulations and the safety of opioids already on the market.
Opioid addiction remains a growing epidemic in America. Around two million people in the U.S. have an opioid use disorder that involves prescribed opioids, according to the National Academies of Sciences, Engineering, and Medicine. Another 600,000 have a use disorder involving heroin.
Each day, about 90 people in the U.S. alone die from an opioid-related overdose.
The crisis has swamped public health responses in many states and put pressure on the drugmakers who developed and marketed a wide array of supposedly improved and abuse-deterrent opiods.
In response to the threat to public health (and to intensifying political pressure), the FDA has been stepping up its efforts to address opioid prescribing patterns and better police supply of the addictive drugs.
Last month, the FDA asked Endo Pharmaceuticals to pull Opana ER, an extended release formulation of oxymorphone, from the shelves. This was the first time the FDA had made such a move, and followed a report showing a shift from nasal to injected abuse despite Endo's claims for its formulation. About a month later, Endo caved and pulled the plug on its drug.
In expanding its REMS program, the FDA hopes it can better limit exposure to opioids to only those who need it and for only as long as the drugs are needed.
"This regulatory tool is needed to ensure that the benefits of how these drugs are prescribed continue to outweigh the risks of misuse, abuse, addiction, overdose, and death," said Gottlieb in Monday's speech. "It’s time to take direct action to address the close to 200 million opioid analgesic prescriptions each year that are for the immediate release products."
Elsewhere in the federal response to the crisis, the Department of Justice and Department of Health and Human Services announced Thursday what Attorney General Jeff Sessions called "the largest health care fraud takedown operation in American history."
This operation involved over a thousand state and federal law enforcement agents and resulted in charges against 412 defendants, including 56 doctors, who have defrauded taxpayers of a total of $1.3 billion. Of these, 120 have been charged with opioid-related crimes.
"One group of defendants — including six doctors — are alleged to have operated a scheme in Michigan to prescribe patients with unnecessary opioids, some of which ended up for sale on the street. These defendants allegedly billed Medicare for $164 million in false and fraudulent claims," said Sessions.
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