Life Sciences Horizons Brochure 2025 - Flipbook - Page 118
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2025 Horizons Life Sciences and Health Care
Unpredictability persists in DEA quota system
The federal Controlled Substances Act (CSA) requires
the Drug Enforcement Administration (DEA) to use
quotas to manage the amount of Schedule I and II
controlled substances and List I chemicals available
for use in the U.S. for the upcoming year. On an annual
basis, DEA determines the total quantity – aggregate
production quota (APQ) – of each basic class of
Schedule I and II controlled substances and certain
List I chemicals that can be manufactured or procured
for use, and manufacturers request slices from this
aggregate pie to satisfy their individual manufacturing
and procurement needs. However, it is a delicate
balance for DEA to determine the supply adequate
to meet medical, scientific, research, and industrial
needs, while also mitigating opportunities for
diversion and illicit use.
Congress and industry stakeholders have criticized the quota
system for its contribution to drug shortages. According to DEA,
21% of drugs in shortage in 2024 were controlled substances, up
68% from 2023. Drugs subject to quota limitations accounted
for 73% of this number. Once manufacturers determine a drug
shortage is imminent due to a quota-related reason, they can
request assistance from FDA to engage with DEA to address
the issue. Yet, drug shortages continue to persist in spite of
this mechanism.
DEA has made recent attempts to improve the quota allocation
system, including rolling out a quarterly approach to quotas in
2024 that appeared to cause more disruptions than it solved,
causing DEA to backtrack. DEA has also sought to rely more on
ARCOS monthly reporting data to obtain real-time sales and
purchase data to understand patient and industry demand.
Still, uncertainties remain in the process. DEA can increase
a substance’s APQ during the year, but there is no way to tell
beforehand whether DEA will do so, or what the increase will be
if it does. Manufacturers may also request supplementary quota
during the year, but the success of the request hinges on the
manufacturer’s rationale for needing additional quota, as well as
how much of the aggregate quota of the substance remains, but
DEA typically does not explain its reasoning if a quota request is
not granted in full.
We have found that timely and well-supported quota requests and
supplemental requests increase the chance that adequate quota
will be provided. DEA continues to examine potential areas for
improvement in the quota system.
Lynn Mehler
Partner
Washington, D.C.
Stephanie Agu
Senior Associate
Miami
