The Federal Role in Addressing the Adderall Drug Shortage

The Federal Role in Addressing the Adderall Drug Shortage

INSIGHTi

The Federal Role in Addressing the Adderall
Drug Shortage
May 4, 2023
Adderall is a combination medication (amphetamine/dextroamphetamine) used to treat attention deficit
hyperactivity disorder (ADHD). The immediate release formulation of Adderall and its generic versions
have been in a shortage for several months in the United States. The shortage was reportedly caused by a
number of factors including an increase in Adderall prescriptions over the past several years. Additional
causes of this and other drug shortages may include manufacturing and quality issues (e.g.,
contaminants); lack of transparency (e.g., lack of information about drug quality and supply reliability);
and business decisions made by individual firms (e.g., low profit margins leading to market exit and
mergers resulting in a limited number of manufacturers). Some have also pointed to U.S. reliance on
foreign sources for raw materials used to make medications.
The Food and Drug Administration (FDA) is responsible for addressing U.S. drug shortages. However,
because Adderall is a Schedule II controlled substance under the Controlled Substances Act (CSA), the
Drug Enforcement Administration (DEA) also regulates the available supply of Adderall.
This Insight describes the federal role in managing drug shortages in the United States in the context of
the current Adderall shortage and provides some policy options for Congress.
FDA Role in Addressing Drug Shortages
FDA’s authority to mitigate drug shortages has been expanded in response to previous shortages. For
example, the Food and Drug Administration Safety and Innovation Act of 2012 (P.L. 112-144) amended
the Federal Food, Drug, and Cosmetic Act to require manufacturers of selected critical prescription drugs
to notify FDA of supply disruptions in certain instances and to require FDA to publish a list of drug
products that are in shortage. Other requirements, and authorities granted under this and other laws, are
discussed in CRS In Focus 11058, Drug Shortages: Causes, FDA Authority, and Policy Options.
Amendments made by the Coronavirus Aid, Relief, and Economic Security Act (P.L. 116-136, CARES
Act) were intended to increase FDA’s ability to mitigate drug shortages and included, among other
authorities, an expansion of manufacturer reporting requirements and an enhancement of FDA’s ability to
expedite the review of selected products or procedures. Provisions in the Consolidated Appropriations
Act, 2023 (P.L. 117-164), further enhanced FDA’s ability to mitigate product shortages in part by
Congressional Research Service
https://crsreports.congress.gov
IN12156
CRS INSIGHT
Prepared for Members and
Committees of Congress

Congressional Research Service
2
enhancing FDA’s visibility into foreign medical product supply chains and directing FDA to provide
guidance to members of industry relating to product expiration date extensions.
FDA responds to drug shortages in a variety of ways. For example, FDA may collaborate with industry
stakeholders to determine reasons for drug shortages. FDA may also choose to support the extension of
expiration dates for products, expedite the approval of new production lines or raw source materials to
support the increased manufacturing of a product, or work with manufacturing firms to identify additional
avenues for increased drug manufacturing.
FDA also works with DEA to address drug shortages, and both FDA and DEA are required to report to
Congress regarding the conditions of and agency decisions concerning drug shortages, including the
agencies’ actions to mitigate them.
DEA Role in Regulating Drug Supply
As part of its mission to prevent diversion of controlled substances while ensuring an adequate supply for
U.S. need (and as required under the CSA), DEA sets annual aggregate production quotas as well as
individual manufacturing quotas for controlled substances in Schedules I and II of the CSA. DEA tracks
the production of controlled substances, enforces various reporting requirements, and receives year-end
reports from manufacturers. Manufacturers may request adjustments to their given quotas at any time.
DEA sets individual manufacturing quotas for the active ingredient in Adderall
(amphetamine/dextroamphetamine). At least one drug manufacturing company pointed to issues in
adjusting its manufacturing quota with DEA during the Adderall shortage but provided no details or
further information on issues with DEA processing of its quota application. Drug manufacturers will
generally not share this detailed information, and DEA does not provide details regarding individual quota
applications, because the details are considered confidential and proprietary to the manufacturer.
Telehealth and the Increase in Adderall Prescriptions
During the public health emergency related to the COVID-19 pandemic, DEA made special allowances
for the practice of telemedicine (where a practitioner is at a location remote from a patient and
communicates with or treats the patient using a telecommunications system) and prescribing to
accommodate patient access to controlled substances. Factors related to this ease of access appears to
have contributed to the increase in Adderall prescriptions during the pandemic. (This is not to say the
prescriptions were medically inappropriate.) However, at least one DEA registrant is alleged to have
unlawfully dispensed Adderall during this time. The public health emergency and related special
telemedicine accommodations are set to expire on May 11, 2023 (although DEA indicated telemedicine
flexibilities may temporarily be extended). This may contribute to a decline in prescriptions issued for
Adderall.
Potential Policy Options for Congress
Drug manufacturers have reported that they do not expect the Adderall shortage to continue much longer,
but drug shortages in the United States remain a serious and persistent public health concern. Congress
may consider a range of policy options to address future shortages such as enhancing reporting
requirements for drug manufacturers (e.g., strengthening penalties for a manufacturer’s failure to report a
permanent discontinuance in or interruption of the manufacture of a drug); incentivizing production of
certain drugs in shortage; and incentivizing manufacturers to invest in new technologies and develop and
maintain high-quality manufacturing practices.
Congress may also consider amending the CSA to change manufacturing quota processes and
requirements. As DEA has noted, quotas are determined based on prescription and other data, thus aiming

Congressional Research Service
3
to ensure an adequate supply for patients and research while preventing overproduction that may lead to
diversion for misuse. In the past, DEA has been pressured to both increase and decrease supplies of
Schedules I and II controlled substances. However, the agency relies on its statutory and regulatory
requirements while it contends with a dual and sometimes conflicting mission in ensuring an adequate
supply while preventing diversion and misuse.

Author Information

Lisa N. Sacco
Hassan Z. Sheikh
Analyst in Illicit Drugs and Crime Policy
Analyst in Health Policy

Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff
to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of
Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of
information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role.
CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United
States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However,
as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the
permission of the copyright holder if you wish to copy or otherwise use copyrighted material.

IN12156 · VERSION 1 · NEW