DEA unveils new rule on opioid manufacturers after criticism

A new policy from the Drug Enforcement Administration (DEA) aims to improve the agency’s quotas of controlled substances, with the intent of preventing manufacturers from overproducing opioids.

A proposed rule published Wednesday would further limit excess quantities of medications that might be vulnerable to diversion for illicit distribution and use, the agency said in a statement.

Every year, the DEA sets a quota for how many opioid pills drugmakers are allowed to produce in the U.S. The quotas are set by the DEA with input from the Food and Drug Administration (FDA) and drug manufacturers. 

{mosads}DEA is charged with keeping controlled substances from being diverted for abuse. The proposed rule would require that appropriate quota reductions be made after estimating the potential for pills to be sold illegally. 

The proposal comes after an internal watchdog report showed the agency allowed drugmakers to increase production of opioids even as overdose deaths were skyrocketing.

According to the report, the DEA permitted drugmakers to increase their production of oxycodone, a highly addictive painkiller, by 400 percent between 2002 and 2013.

The DEA didn’t substantially cut the quota until 2017, when opioid overdose deaths reached a peak in the U.S.

Under the proposal, the diversion potential would be based on rates of overdose deaths and abuse, the overall public health impact related to specific controlled substances and may include other factors as appropriate, the agency said.

The proposal would also implement provisions of the Support Act, legislation passed last year to address the nation’s opioid epidemic. 

The proposed rule seeks to introduce “use-specific” quotas, which would include quantities of controlled substances for use in commercial sales, product development, packaging/repackaging and labeling/relabeling or replacement for quantities destroyed.