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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Highlights
What GAO Found
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.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| 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. |
Closed – Implemented
|
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
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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. |
Closed – Implemented
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.
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| Food and Drug Administration | 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. |
Closed – Implemented
FDA has been taking steps to improve its drug shortage tracking capabilities since 2011. In March 2016, FDA reported that it had developed a system to track drug shortages--the "Shortage Tracker." In June 2017, FDA reported this system has been fully operational for over a year. The Shortage Tracker allows the agency's drug shortage staff to manage their daily workload in a systematic manner and track data about drug shortages, including their causes. It was also used by FDA to prepare its most recent annual report to Congress on drug shortages.
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| Food and Drug Administration | 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. |
Closed – Implemented
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.
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| Food and Drug Administration | 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. |
Closed – Implemented
In September 2015, FDA reported that it had developed results-oriented performance metrics that can help evaluate program performance, demonstrate progress in achieving results, balance competing priorities, and inform decision making. Four such metrics have been adopted that are related to either time or the percentage of items completed. They are: assigning staff responsibility to work on a shortage, time elapsed until the scope of a shortage has been assessed, determining the need to obtain an internal medical consult related to a product discontinuation, and the completion of medical necessity determinations. In July 2106, FDA confirmed that it is routinely capturing and recording the information associated with these metrics in its new "Shortage Tracker" data system, which was implemented in March 2016. FDA also shared screen shots from its new "Shortage Tracker" system showing how such information is captured. Although FDA is currently reviewing this data on an ad hoc basis, the staff reported that they hope to begin monitoring these metrics each quarter.
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Decision makingDrug pricingGeneric drugsInventory control systemsManufacturing industryPatient care servicesPerformance measuresPharmaceutical industryPrescription drugsPrices and pricingProfessional ethicsProgram evaluationPublic healthReporting requirementsStrategic planningSupply chain managementConsolidationSupply and demand