Dive Brief:
- The Drug Enforcement Administration plans to more tightly manage the manufacturing of opioids, proposing to take drug abuse into account when setting annual production limits for drugmakers that make the potentially addictive painkillers.
- "Under this proposed new rule, if DEA believes that a company's opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make," said Attorney General Jeff Sessions in prepared remarks for a speech Tuesday in Raleigh, North Carolina.
- By federal law, the agency sets production quotas for drugs classified as Schedule I or Schedule II controlled substances. Through the new rule, drug abuse — or diversion, in law enforcement terms — would be added to the list of factors the DEA uses to set those quotas.
Dive Insight:
The DEA's move is another step by the Trump administration to combat the opioid abuse epidemic, an effort that has begun to focus more on drugmakers.
States and the federal government have targeted wholesalers as well as opioid manufacturers for the hand the companies may have had in spurring the public health crisis.
Under the proposed rule, the DEA could curtail production of drugs containing oxycodone, fentanyl and other controlled substances based on the degree to which those medicines are abused — potentially affecting drugmakers like Purdue Pharma L.P. and Johnson & Johnson.
Along with taking drug diversion into account, the DEA would be able to more closely tap information from states and the Department of Health and Human Services to set its annual limits.
In a separate announcement April 17, the Department of Justice said the DEA had reached an agreement with 48 state Attorneys General to share prescription drug data. Through a system called ARCOS, the DEA collects 80 million records from manufacturers including information on distribution figures and inventory.
The agency aims to share those details with states in an effort to help combat abuse and criminal activity related to prescription painkillers.
Earlier this month, the Department of Justice expressed interest in joining settlement talks with drugmakers that make painkillers, seeking to participate in litigation consolidated before U.S. district court in Ohio.