Justice Department Proposes New Limits on Opioid Manufacturing

This week U.S. Attorney General Jeff Sessions proposed changes to U.S. drug manufacturing quotas as part of the Justice Department’s new initiatives to combat the opioid epidemic. In the last decade, more than 250,000 deaths were related to opioid overdose, according to the New York Times.

Sessions proposed that the Drug Enforcement Administration (DEA), which has authority to set opioid production limits, would reduce a company’s opioid production if DEA officials believe the drugs are being diverted for misuse. This determination would be made using information from multiple sources, including the DEA’s confidential Automation of Reports and Consolidated Orders System, looking for what is known as “pill dumping.” For example, the DEA recently disclosed that it has tracked two shipments of millions of pills to pharmacies in small towns in West Virginia.

Sessions also announced that the DEA is working with 48 state attorneys general to share information from the DEA’s database to monitor the flow of painkillers from manufacturer to distribution point. The attorneys general have agreed that their states will provide the DEA with information from state prescription-monitoring programs, which track the prescriptions that doctors write for patients. Together, this information may provide a road map for the opioid crisis and may be able to correlate shipments of opioids with rising opioid-related deaths in communities.

West Virginia Attorney General Patrick Morrisey called the DEA’s current quota system “perverse” because it relies on the number of pills manufacturers expect to sell in a year rather than using an analysis of “the legitimate medical needs of patients.” The proposed rule change on controlled substances quotas is currently open for public comment on www.regulations.gov.


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