Drug Shortages:

FDA's Ability to Respond Should Be Strengthened

GAO-12-116: Published: Nov 21, 2011. Publicly Released: Dec 15, 2011.

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What GAO Found

The number of drug shortages has grown substantially since 2006. In total, 1,190 shortages were reported from January 1, 2001, through June 20, 2011, according to UUDIS data. From 2006 through 2010, the number of drug shortages increased each year. A record number of shortages were reported in 2010, and 2011 is on pace to surpass 2010's record. Sixty-five percent of shortages involved drugs that were in short supply more than once. On average, shortages lasted 286 days (over 9 months). Over half of shortages reported from January 1, 2009, through June 20, 2011, that UUDIS identified as critical-- because, for example, alternative drugs were not available--involved generic injectable drugs. Certain therapeutic classes (such as anesthetic, oncology, and anti-infective drugs) were among those most often in short supply. FDA responds to drug shortages by taking actions to address the underlying causes and to enhance product availability, for example by providing assistance to manufacturers to resolve manufacturing or quality problems that can result in a shortage. When informed of the possibility of a shortage in advance, FDA has increasingly been able to prevent potential drug shortages from occurring. FDA prevented 50 potential shortages during the first half of 2011. As part of its response, FDA provides general information about drug shortages to the public via its website. FDA is constrained in its ability to protect public health from drug shortages due to its lack of authority to require manufacturers to report actual or potential shortages to the agency or the public, or to require manufacturers to take certain actions to prevent, alleviate, or resolve shortages. As a result, the agency's approach to managing drug shortages is predominately reactive. FDA's ability to protect public health is also constrained by management challenges that weaken its ability to respond to drug shortages. For example, FDA does not systematically maintain data on drug shortages, without which it is unable to monitor trends and enhance its ability to address the causes of drug shortages. In addition, FDA has provided limited resources to manage its response to drug shortages and lacks related performance measures and priorities. Congress should consider establishing a requirement for manufacturers to report to FDA any changes that could affect the supply of their drugs. In addition, FDA should enhance its ability to respond to drug shortages, for example, by developing an information system to manage data about shortages. HHS outlined actions it plans to take that are consistent with GAO's recommendations.

Why GAO Did This Study

In recent years, nationwide shortages of prescription drugs have increased, preventing patients from accessing medications essential to their care. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), established a Drug Shortage Program with a mission of helping to prevent, alleviate, and resolve shortages. FDA receives information about shortages from manufacturers, though this reporting is generally voluntary, as well as from the American Society of Health-System Pharmacists (ASHP). ASHP tracks nationwide shortages for its members through a partnership with the University of Utah Drug Information Service (UUDIS). GAO was asked to review trends in shortages and examine FDA's response. In this report, GAO (1) reviews trends in drug shortages, (2) describes FDA's response, and (3) evaluates FDA's ability to protect public health through its response to drug shortages. GAO analyzed UUDIS data, interviewed officials from FDA, health care professional associations, and industry, and also examined relevant statutes, regulations, information, and documents.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Matter for Congressional Consideration

    Matter: To strengthen FDA's ability to respond to drug shortages, Congress may wish to consider establishing a requirement for manufacturers to report potential or actual supply disruptions to FDA. Such notification requirements should call for manufacturers to notify FDA of any changes, interruptions, or adjustments that could affect the supply of their drugs. Congress may also wish to consider providing FDA with the authority to seek civil monetary penalties or use other enforcement mechanisms to ensure compliance with this requirement.

    Status: Closed - Implemented

    Comments: In July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA), (P.L. 112-144) was enacted with a requirement that manufacturers report to the Food and Drug Administration any changes that could affect their ability to manufacture their drugs and thus potentially lead to a drug shortage. Specifically, FDASIA requires manufacturers of drugs that are life-supporting, life-sustaining, or used to prevent or treat debilitating diseases or conditions to notify FDA six months in advance if they either plan to discontinue manufacturing the drug or anticipate an interruption in manufacturing that is likely to lead to a meaningful disruption in the drug?s supply.

    Recommendations for Executive Action

    Recommendation: To strengthen FDA's ability to protect the public health through its response to drug shortages, the Commissioner of FDA should ensure that FDA's strategic plan articulates goals and priorities for maintaining the availability of all medically necessary drugs--including generic drugs.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: FDA stated that since this report was issued in November 2011, it did not have an update to provide in 2012. FDA plans to provide an update in 2013.

    Recommendation: To strengthen FDA's ability to protect the public health through its response to drug shortages, the Commissioner of FDA should develop an information system that will enable the Drug Shortage Program to manage its daily workload in a systematic manner, track data about drug shortages--including their causes and FDA's response--and share information across FDA offices regarding drugs that are in short supply.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: FDA stated that since this report was issued in November 2011, it did not have an update to provide in 2012. FDA plans to provide an update in 2013.

    Recommendation: To strengthen FDA's ability to protect the public health through its response to drug shortages, the Commissioner of FDA should assess the resources allocated to the Drug Shortage Program to determine whether reallocation is needed to improve the agency's response to drug shortages.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: FDA stated that since this report was issued in November 2011, it did not have an update to provide in 2012. FDA plans to provide an update in 2013.

    Recommendation: To strengthen FDA's ability to protect the public health through its response to drug shortages, the Commissioner of FDA should develop results-oriented performance metrics to assess and quantify the implementation of the agency's goals and FDA's response to drug shortages.

    Agency Affected: Department of Health and Human Services: Food and Drug Administration

    Status: Open

    Comments: FDA stated that since this report was issued in November 2011, it did not have an update to provide in 2012. FDA plans to provide an update in 2013.

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