Controlled Substances: DEA Needs to Better Manage Its Quota Process and Improve Coordination with FDA

GAO-15-494T Published: May 05, 2015. Publicly Released: May 05, 2015.
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What GAO Found

The Drug Enforcement Administration (DEA) has not effectively administered the quota setting process by which it limits the amount of certain controlled substances available for use in the United States. Each year, manufacturers apply for quotas of controlled substances in order to make certain drugs. DEA, however, has not responded to those applications within the time frames required by its regulations for any year from 2001 through 2014. DEA officials attributed this lack of compliance to inadequate staffing, stating that the agency has been unable to find qualified candidates who are able to pass the necessary background checks and that offers to qualified candidates have been declined. Manufacturers cited late quota decisions as causing or exacerbating some shortages of their drugs.

Additionally, DEA’s weak internal controls jeopardize the agency’s ability to effectively manage the quota process. For instance, agency officials said that DEA conducts some data checks to ensure the accuracy of its data in its Year-End Reporting and Quota Management System (YERS/QMS), but it has no systematic quality checks to ensure the quota data are accurate. GAO estimates that 44 percent of YERS/QMS records in 2011 and 10 percent in 2012 had errors. DEA officials said that 2011 was the first year manufacturers applied for quota electronically and they expected data from 2012 and beyond to be more accurate.

DEA also lacks critical management information because it does not have performance measures related to setting quotas, and it does not monitor YERS/QMS data to assess its performance. Moreover, DEA does not have reasonable assurance that the quotas it sets are in accordance with its requirements and cannot ensure continuity of its operations, as it does not have protocols, policies, training materials, or other documentation to manage the quota process.

The Food and Drug Administration Safety and Innovation Act (FDASIA) contains provisions that require DEA and the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to coordinate certain efforts to address shortages of certain drugs caused by quotas. Despite this, the agencies have not established a sufficiently collaborative relationship. For example, DEA and FDA sometimes disagree about what constitutes a drug shortage. DEA also has no policies or procedures on how to coordinate with FDA to address shortages caused by quota. Given such barriers to coordination, DEA and FDA cannot effectively address shortages of drugs subject to quota. Additionally, both agencies stated that they were subject to restrictions on exchanging proprietary information, which may be helpful to address drug shortages. DEA and FDA had been working since 2012 to develop a new memorandum of understanding (MOU), which was finalized in March 2015. According to the MOU, the two agencies will still need to develop a plan to share such information.

Why GAO Did This Study

In the last decade, shortages of drugs containing controlled substances, such as narcotics and stimulants, have increased nationwide, preventing providers and patients from accessing essential medications for treatment. Controlled substances are regulated by DEA because of the potential for abuse and addiction. DEA is responsible for preventing diversion of controlled substances, and also focuses on ensuring that an adequate and uninterrupted supply of these substances is available for legitimate medical and other needs.

This testimony summarizes key findings of GAO’s February 2015 report, Drug Shortages: Better Management of Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved, (GAO-15-202) and includes selected updates that DEA and FDA have taken subsequent to the issuance of that report. Specifically, this statement focuses on
(1) DEA’s administration of the quota process, and (2) coordination activities between DEA and FDA to prevent and mitigate shortages of drugs containing controlled substances. For the report, GAO analyzed data from 2011 and 2012 from YERS/QMS, which is the official record for the quota process. GAO interviewed officials from DEA, FDA, and drug manufacturers. GAO reviewed relevant statutes, regulations, and documents. To update selected information in March and April 2015, GAO reviewed documentation and contacted FDA officials.

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GAO is not making any new recommendations in this testimony. For GAO-15-202, GAO recommended that DEA should take five actions to improve its management of the quota process: (1) strengthen its internal controls of YERS/QMS, (2) establish performance measures related to the quota process, (3) monitor and analyze YERS/QMS data, (4) develop internal policies for setting quotas, and (5) expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by FDASIA. Additionally, in GAO-15-202, GAO recommended that DEA and FDA should take two actions to strengthen their ability to respond to shortages of drugs containing controlled substances: (1) promptly update their MOU (which has now been accomplished), and (2) specifically outline information the agencies will share and time frames for doing so. DEA neither agreed nor disagreed with GAO’s recommendations. HHS agreed with the applicable recommendations.

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