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1 1 (May 4, 2023)

handle is hein.crs/govelmu0001 and id is 1 raw text is: Congressional ____ Sa Research Service 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, PDA 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

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