Premier Urges DEA to Modernize Controlled Substance Quota System

Premier submitted comments on the Drug Enforcement Administration (DEA)’s proposal to revise applications for manufacturing and procurement quotas for controlled substances. In its letter, Premier expressed support for DEA’s mission to establish aggregate production quotas (APQs) that help prevent diversion and misuse of controlled substances while ensuring appropriate patient access. However, Premier noted that the current APQ framework contributes to ongoing supply chain challenges, medication shortages and operational burdens for healthcare providers. Accordingly, Premier urged DEA to pursue broader reforms that would improve supply chain visibility, better align production with patient and provider needs, and create a more flexible and responsive quota-setting process.

Specifically, Premier recommends that the DEA:

• Modernize the APQ process by incorporating greater flexibility and more frequent quota assessments throughout the year to better align production with evolving patient care needs and market conditions.
• Improve coordination and timing of quota decisions across active pharmaceutical ingredient manufacturers and finished-dose manufacturers to reduce supply chain disruptions and prevent avoidable shortages of critical medications.
• Adopt a more forward-looking, demand-driven approach to quota setting that incorporates forecasted utilization, emerging clinical needs and real-world market dynamics rather than relying predominantly on historical data.
• Establish mechanisms, such as reserve quota capacity or safety-stock allowances, that enable manufacturers to respond more rapidly to unexpected demand increases, quality-related manufacturing disruptions and other supply chain emergencies.
• Increase collaboration with stakeholders across the healthcare ecosystem—including the FDA, healthcare providers, pharmacists, manufacturers and supply chain partners—to improve visibility into supply challenges and support patient access to medically necessary controlled substances.
• Create a Chief Pharmacy Officer within the DEA to provide clinical expertise, strengthen coordination with healthcare stakeholders, enhance responsiveness to drug shortages and ensure patient access considerations are integrated into quota and controlled substance policy decisions.