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.

Matter for Congressional Consideration

  1. 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.

    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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: FDA had increased the number of personnel devoted to drug shortages to 11. This has allowed FDA to assign each manufacturer experiencing a shortage a specific contact person, which has improved information sharing. FDA can now respond more quickly to prevent or resolve shortages. In addition, increasing the number of personnel working on drug shortages has allowed staff to play a bigger role in revising relevant policies and procedures. FDA also took the step of assigning drug shortage coordinators in each of its 20 district offices. These coordinators have helped bring drug shortage-related concerns to light earlier, such as violative inspections at establishments that manufacture a large volume of drugs. Finally, FDA has also expanded its ability to respond with additional experts from throughout the agency. In addition to the drug shortage staff, FDA estimates that an average of 25 additional staff members work on any given shortage, including staff from the clinical review divisions, chemistry groups, compliance staff, and others as required based on the expertise needed to address the shortage.

    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

  2. Status: Open

    Comments: In 2013 FDA reported that it had developed a drug shortage database to track and manage the Drug Shortage Staff's daily workload, as well as to track active shortages, causes of shortages, and FDA responses to shortages. The database is shared across FDA offices to enable communication and coordination regarding drugs that are in short supply. FDA has also used this database to improve the information available about specific shortages on our public drug shortages website. In August 2014 FDA provided an update, noting that it had further improved its tracking capability with the establishment of the new Drug Shortage Data System. This system aims to enhance the efficiency and consistency of drug shortage data entry. It also revises business rules, standardizes key data elements, and adds automated data integrity checks to ensure that data are accurate and complete for analysis, and centralizes various databases currently used by Drug Shortage Staff to assess the potential impact of shortages. The system is designed to simplifies data entry process by auto-populating certain fields and is anticipated to further streamline the basic research that is conducted when a shortage or a potential shortage is reported. FDA is working on backfilling the system with data on shortages from the last few years and has plans to develop more sophisticated reporting capabilities for analyzing these data. GAO is continuing to monitor this system as it is fully implemented and refined.

    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

  3. Status: Closed - Implemented

    Comments: This recommendation was included as a provision in the Food and Drug Administration Safety and Innovation Act (P.L. 112-144), which was enacted in July 2012. This law required FDA to submit a strategic plan to enhance the agency's' ability to prevent and mitigate shortages. FDA issued this strategic plan in October 2013. It outlines two goals: 1) strengthening FDA's ability to respond to notices of a disruption in supply, including improving mitigation tools and 2) developing long-term prevention strategies to address the underlying causes of supply disruptions and prevent drug shortages. The plan also addresses FDA's oversight of drug shortages, examines what is known about the causes of shortages, describes FDA's current efforts to resolve existing shortages and discusses how it responds to disruptions in supply. In addition, it outlines the actions FDA is taking--or plans to take--to strengthen and expand its efforts and identifies potential actions for other stakeholders to consider.

    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

  4. Status: Open

    Comments: In 2014, FDA outlined the information included in its first Annual Report to Congress on drug shortages. It includes the number of manufacturers that notified the Secretary during the year of a discontinuance or interruption in the production of certain prescription drugs that are life-saving, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition. It also notes major actions taken by the Secretary to prevent or mitigate drug shortages, including the number of drug applications and supplements that were expedited to prevent or mitigate a shortage and the number of establishment inspections or reinspections similarly expedited. The number of and description of the instances in which FDA exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage and the number of drug shortages occurring during the first three quarters of 2013 are also provided. The report contains the names of manufacturers issued letters because they failed to notify the agency of a discontinuance or interruption in manufacturing as required law. The report also describes its effort to communicate internally with relevant staff regarding shortages and its coordination with the Drug Enforcement Administration concerning shortages of controlled substances. While useful and important information, these items do not constitute results-oriented performance metrics. Such metrics can help evaluate program performance, demonstrate progress in achieving results, balance competing priorities, and inform decision making. They should, whenever possible, demonstrate a program's contributions toward the long-term outcomes, or the results the agency expects a program to achieve. Specifically, such performance measures link to agency and department goals, include explanatory information on the measures, show baseline and trend data for past performance, use intermediate measures to show progress or contribution to intended results, focus on public health outcomes, address important dimensions of the agency's performance, identify projected target levels of performance for multiyear goals, and fully address mission-critical management challenges. Such measures are not reflected in FDA's annual report on drug shortages.

    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

 

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