Comments on DEA’s proposed rule on manufacturing and procurement quotas

In May 2026, the DEA proposed a new rule to revise existing regulations around the management of quotas for Schedule I and II controlled substances, specifically around manufacturing and procurement quotas, by collecting new production-cycle data from manufacturers and splitting several quota subcategories, framing both changes as tools to anticipate and prevent drug shortages. In response, Wosińska and Graham submitted a comment letter developing three observations for why the rule misdiagnoses the problem and, as drafted, would do little to build drug shortage resilience.

1. Production-cycle data collection is useful only if paired with the flexibility to act on it. DEA needs this data only because it releases quota in installments rather than the single annual allocation the statute contemplates, and quota keyed to a production plan cannot be used once that plan slips. DEA’s track record of shrinking inventories and multiplying sub-quotas suggests the data is more likely to tighten the system than to build resilience.

2. Splitting the subcategories adds complexity that the agency should be shedding. The system already generates thousands of separate allocation decisions from only a few dozen substances, and each additional subcategory multiplies the points where mismatches can arise. The domestic/export distinction is informational and should be met by a reporting requirement, not a new binding sub-quota.

3. The domestic/export split does not address the demand-estimation loop that drives caps below medical need. Because caps are set on historical sales data, and sales reflect the ceiling rather than true demand whenever a cap binds, each year’s shortfall becomes the next year’s baseline, ratcheting caps downward below medical need. The split also does nothing to capture demand spillovers across therapeutic substitutes, the pattern that spread the Adderall shortage to methylphenidate and lisdexamfetamine.

Wosińska and Graham concluded their comments with a set of policy recommendations for pairing the new timeline data collection with allocation reform, unused quota rollover, reporting-only treatment of the domestic/export distinction, improved demand estimation, revisited inventory limits, and finalization of DEA’s long-pending suspicious-orders rule.

Read the full comment letter