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Drug Shortage Legislative Objectives

ASHP continues to work with members of Congress to craft comprehensive legislation to end drug shortages. ASHP, along with our partners, the American Hospital Association, American Society of Clinical Oncology, and the American Society of Anesthesiologists, has developed legislative objectives based off of the 2017 Drug Shortages Roundtable and the 2018 Summit on Drug Shortages to Examine Impact on National Security and Health Care Infrastructure.

  1. Require manufacturers to provide the Food and Drug Administration (FDA) with more information on the causes of shortages and their expected durations and allow public reporting of this information.
    Current law requires manufacturers to notify the FDA when there is a discontinuance or interruption in manufacturing. However, manufacturers are not required to disclose the cause of the interruption or provide a timeline for resolution. Some manufacturers do this voluntarily, but inconsistent information hinders FDA's ability to mitigate shortages. Title X of FDA Safety and Innovation Act (FDASIA) should be strengthened to require these notifications be published in the FDA drug shortages database and include the cause of the interruption and a timeline to address the shortage.

  2. Require drug manufacturers to disclose manufacturing sites, including use of contract manufacturers, and sources of active pharmaceutical ingredients (APIs) to FDA.
    FDA lacks access to key information to predict the impact that regional disasters, geopolitical instability, or manufacturing problems at production sites may have on the pharmaceutical supply chain. The Federal Food, Drug, and Cosmetic Act (FFDCA) should be strengthened to require manufacturers to disclose to FDA the location of drug production, including when a contract manufacturer is used, and also disclose sources of API. FDA can use this information to more accurately assess the scope and duration of a shortage as well as identify potential supply disruption for related products, including associated medical devices.

  3. Require manufacturers to establish contingency plans to maintain supply of a drug in the event of a manufacturing disruption.
    Manufacturers cannot always predict why or when a shortage will occur. Manufacturing disruptions can be caused by natural disasters, quality issues, access to raw materials, or business decisions which may include discontinuation of a product. Such shortages negatively impact patient safety and access to care. The FFDCA should be amended to include a requirement that manufacturers develop and maintain business continuity contingency plans for future supply disruptions that are reviewed during FDA plant inspections.

  4. Establish incentives to encourage manufacturers to produce drugs in shortage or at risk of shortage.
    Drugs with fewer than three manufacturers are at greatest risk for shortages. FDA should recommend incentives to encourage manufacturers to begin producing drugs that are in shortage or have a history of being in short supply.

  5. Require the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) to conduct a risk assessment of national security threats associated with manufacturing and distribution of critical drugs, their APIs, and associated medical devices used for preparation or administration.
    Relying predominantly on other countries for necessary ingredients to manufacture crucial drugs, APIs, and devices required to safely prepare and administer drugs presents a potential threat to the stability of the U.S. drug supply. At present, more than 80% of API is produced in China and India - this leaves our supply chain vulnerable to disruption and puts API sourcing at risk. In addition to critical drug products, medical devices necessary for the preparation and administration of drugs are a critical part of healthcare infrastructure. Devices like syringes, needles, and tubing for administration of intravenous drugs have been affected by shortages.

    HHS and DHS should 1) conduct a review of priority risks to API and finished pharmaceutical manufacturing and distribution systems, including identification of ways the U.S. government can support preparedness and resilience of critical infrastructure in the pharmaceutical sector, and 2) conduct an assessment of risk for foreign manufacturing of API, finished pharmaceuticals, and medical devices, and 3) establish a standing forum to engage the private sector, including pharmacists, hospitals, physicians and manufacturers, to mitigate these risks.

  6. Require FDA to publish quality ratings for drug manufacturers and 503B outsourcing facilities preparing copies of drug products under the exemption for products on FDA's shortage list, or make public such information that would allow purchasers to assess the relative quality of 503B outsourcing facilities.
    Drug shortage data indicate that a majority of recent shortages were due to manufacturing quality issues. Hospitals and health systems often make purchasing decisions without any ability to access manufacturing quality data. FDA inspection notices and warning letters describe inspections that are several months old and do not provide timely information or satisfactory resolution of problems identified and do not identify specific products manufactured at that facility. Healthcare personnel need a mechanism to inform purchasing decisions based on manufacturer quality.

    FDA should publish manufacturing quality ratings or make public information that would allow purchasers to compare manufacturing quality when making purchasing decisions. Similar ratings or information should be made public to assess quality of products produced in 503B outsourcing facilities.

  7. Require the Federal Trade Commission (FTC) to evaluate the potential for drug product supply chain interruptions when considering manufacturer consolidations.
    Consolidation in the pharmaceutical industry has disrupted manufacturing lines and created quality issues, resulting in extended-duration shortages of critical drug products. To prevent shortages related to mergers and acquisitions, FTC review of proposed consolidations in the pharmaceutical industry should require analysis of potential public health impacts - specifically, the likelihood the transaction will create new and/or exacerbate existing drug shortages.