Premier Provides Input on DEA's Quota Allocation Process for Opioids

Premier submitted comments cautioning the Drug Enforcement Agency (DEA) to carefully consider how a reduction in manufacturing quotas for certain opioids could exacerbate recent drug shortages for injectable opioids and have a negative effect on patients with a legitimate and serious need for these medications. In November, the DEA issued proposed aggregate production quotas for 2026 for Schedule I and II Controlled Substances. The proposal seeks to lower the annual production quotas of several critical medications used in acute settings that have historically bene on the FDA drug shortage list such as fentanyl and morphine.

Echoing past comments to the DEA, Premier advocated for a complete overhaul of the quota allocation process, abandoning quotas based on weight in favor of establishing quotas based on dosage form and differentiating between injectables and solid oral dosage forms. At minimum, Premier urges the DEA to leverage statutory authority provided by Congress in 2018 under the original SUPPORT Act to establish APQs in terms of pharmaceutical dosage form for all CII controlled substances on the FDA drug shortage list. Ensuring that injectable opioids are always available for clinically appropriate care should not be a rare occurrence for the DEA - it must be a priority.

Premier will continue to work with the DEA and other stakeholders to develop sustainable solutions that balance preventing diversion and abuse of opioids with ensuring adequate supply for clinically appropriate care.