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1 1 (December 27, 2018)

handle is hein.crs/govyxb0001 and id is 1 raw text is: Conresioa Reeac Sevc December 27, 2018 Drug Shortages: Causes, FDA Authority, and Policy Options Drug shortages have remained a serious and persistent public health concern, despite the prevention and mitigation efforts of Congress, the Food and Drug Administration (FDA), and health care providers. While the number of new drug shortages has declined since its peak in 2011, many medically necessary products, such as sterile saline solution and sodium bicarbonate, remain in shortage. According to FDA, some active drug shortages have persisted for more than eight years. Figure I. Number of New Drug Shortages, 2010-2017 250 200 150 100 2010 2011 2012 2013 2014 2015 2016 2017 Source: FDA annual reports on drug shortages for calendar years 2015, 2016, and 2017. Presentation from November 27, 2018, public meeting, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions, https://healthpolicy.duke.edu/sites/default/files/ atoms/files/duke-fdadrug.shortagespresentation_slides_0.pdf. Causes of drug shortages 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). Current Law Requirements The Federal Food, Drug, and Cosmetic Act (FFDCA) and corresponding regulations require that drug manufacturers submit to FDA certain information pertaining to shortages. More specifically, FFDCA Section 506C requires that the manufacturer of a prescription drug that is life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, as specified, notify FDA of any permanent discontinuance or interruption in the manufacture of a drug that is likely to disrupt its United States supply. The manufacturer is required to notify FDA at least six months prior to such interruption, or, if not possible, as soon as practicable, which FDA regulation specifies to be no later than five business days after the permanent discontinuance or interruption occurs. FDA must maintain and make public an up-to-date list of drugs that are in shortage (FFDCA §506E). The list must include * the name of the drug in shortage, * the name of the drug manufacturer, * the estimated duration of the shortage, as determined by FDA, and * the reason for the shortage, as determined by FDA, selecting from the following reasons: (1) requirements related to complying with good manufacturing practices, (2) regulatory delay, (3) shortage of an active ingredient, (4) shortage of an inactive ingredient component, (5) discontinuance of the drug's manufacture, (6) delay in drug's shipping, or (7) demand increase for the drug. FDA maintains its list in the form of a searchable database on its website that provides information about current and resolved drug shortages and discontinuations reported to the agency. FDA maintains a separate list for biologics that are in shortage. The agency also is required to submit to Congress an annual report on drug shortages, which must include the number of actual and prevented shortages and manufacturer notifications; FDA communication procedures; and specified details of FDA shortage prevention and mitigation actions, among other things. (FFDCA §506C-1). Like FDA, the American Society of Health-System Pharmacists (ASHP) also tracks drug shortages, although there are differences in how the two track and report information. FDA's list is generally targeted toward the public, while ASHP's audience is health care providers. In addition, among other differences, FDA's list is based on manufacturer-provided information, while ASHP's list is based on voluntary reports from health care providers, patients, and others, and is updated more frequently. Actions to Prevent Drug Shortages In 2012, Congress passed legislation to address drug shortages. Title X of the FDA Safety and Innovation Act (FDASIA, P.L. 112-144) expanded reporting requirements related to drug shortages; explicitly authorized FDA to expedite inspections and review of applications to help mitigate or prevent shortages; required FDA to submit annual reports to Congress; required FDA to establish a task force to develop and implement a strategic plan regarding its response to preventing and mitigating shortages; and required GAO to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages. In 2016, Section 3016 of the 21St Century Cures Act (P.L. 114-255) authorized https:/crsreports.con, -- -q

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