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DEA Proposes Reduction in US Opioid Manufacturing Quotes

Yesterday, in a joint statement by the US Department of Justice and the US Drug Enforcement Administration (DEA), the government proposed a reduction in the Aggregate Production Quotas (APQ) for certain controlled substances that may be manufactured in the United States next year. The government indicated that its intent was to “cut nationwide opioid prescription fills by one-third within three years.” The proposal decreases manufacturing quotas for six opioids (oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl) by an average of 10 percent, as compared to 2018 quotas.

As the government noted, the action marks the third straight year of proposed reductions. Although the reduction was not formally tied to diversion statistics, the government stated that the reduction was consistent with its announcement earlier this year of a rule amending DEA’s regulations to improve the agency’s ability to consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits.  

The APQ is designed to control the quantities of basic ingredients needed for the manufacture of controlled substances. The APQ is the first step in determining allocations made available for individual US manufacturers to produce controlled substances. Once the APQ is set, the DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. The DEA noted that these individual manufacturer allocations may be subject to further revision during the course of a year based upon a number of factors, including increased or decreased sales or exports, new manufacturers entering the market, new product development or product recalls.

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About this Author

Karen Owen Gibbs, Health, Life sciences, Attorney, McDermott Will, Law Firm
Partner

Karen Owen Gibbs is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  She has extensive background in regulatory, compliance and policy issues in the health care and life sciences industries, including pharmacies (retail, mail and specialty), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, device manufacturers, durable medical equipment (DME) suppliers, hospitals, retail clinics and senior living facilities.   Karen also has substantial experience advising investors and lenders focused on those...

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