Attorney General Jeff Sessions today announced that the Drug Enforcement Administration (DEA) has issued a Notice of Proposed Rulemaking (NPRM) that would affect its limits on annual opioid production.
“Better information means better decisions,” Sessions said. “Under the proposed rule, DEA’s opioid production limits would be more responsive to the risk of drug abuse by explicitly taking diversion into account. It’s a common sense idea: the more a drug is diverted, the more its production should be limited. Today’s proposed rule will give DEA more information to help the agency protect law-abiding Americans from the threat of drugs — and that makes all of us safer.”
Under the NPRM, DEA will take into consideration the extent that a drug is diverted for abuse when it sets its annual opioid production limits. If DEA believes that a particular opioid or a particular company’s opioids are being diverted for misuse, then DEA would be able to reduce the amount that can produced in a given year. These smarter limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potentially addictive drugs while ensuring that the country has enough opioids for genuine medical, scientific, research and industrial needs.
Further, the rule would allow DEA to set its annual limits using information not only from its own Automation of Reports and Consolidated Orders (ARCOS) system, but also from the Department of Health and Human Services, the FDA, the CDC, Medicare and Medicaid, and the states.