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    Subject Term: "Drug enforcement"

    2 publications with a total of 8 open recommendations
    Director: Seto Bagdoyan
    Phone: (202) 512-6722

    5 open recommendations
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal requesting authority to require SSNs for all individuals, regardless of whether they hold an individual or business registration.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us it is exploring the possibility and practicality of implementing policy or rule changes that would require Social Security Numbers (SSN) from all persons applying for a DEA Registration as a practitioner or mid-level practitioner. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop policies and procedures to validate SSNs and apply the policies and procedures to all new and existing SSNs in the CSA2; such an approach could involve collaborating with SSA to assess the feasibility of checking registrants' SSNs against the Enumeration Verification System.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that it had initiated discussions with the Social Security Administration (SSA) to determine the legality and feasibility of using SSA's Enumeration Verification System (EVS) to verify SSNs provided during the registration process. DEA stated that SSA has informed both GAO and DEA that its current legislative authorities do not authorize SSA to provide the information to DEA. As a a result, DEA stated that legislative action will be required to allow DEA additional access to EVS. As stated in our report, the use of EVS is one possible approach to validate SSNs. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop a legislative proposal to request access to SSA's full death file.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that the Social Security Administration (SSA) determined that it cannot provide data from the full death file to DEA under existing law for use in administering the DEA Registration Process. DEA also said that if legislative changes allow DEA full access to SSA's full death file, DEA will work with SSA to ensure implementation of the new legislative authority. We continue to believe that DEA should develop a legislative proposal to request access to SSA's full death file and we will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should identify and implement a cost-effective approach to monitor state licensure and disciplinary actions taken against its registrants; such an approach could include using data sources that contain this information, such as the National Practitioner Data Bank or the Federation of State Medical Boards.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us that currently, the Controlled Substance Act and its implementing regulations do not specifically give DEA authority to access state medical licensing boards' databases. DEA also said that it met with representatives of the Federation of State Medical Boards (FSMB) to develop a process that will allow DEA to accomplish the objectives GAO articulated in the draft report. Specifically, DEA said that it is exploring use of the FSMB service to verify the existence and status of state licenses to ensure all applicants for registration who are Doctors of Medicine and Doctors of Osteopathy, or Physician Assistants (in the states that provide this data to FSMB), meet the requirements to possess a DEA Registration. To implement the above described actions, DEA stated it will need to enter into an agreement with FSMB to provide this data in a format that allows real-time access to the data and accommodates the large numbers of applicants for DEA Registrations. DEA also said it obtained information from FSMB to begin the agreement process and is currently obtaining information on data elements that can be used to test user account codes to flag records in the FSMB. We will continue to monitor DEA's progress in implementing this recommendation.
    Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should assess the cost and feasibility of developing procedures for monitoring registrants' criminal backgrounds, such as conducting matches against federal law-enforcement databases, and document decisions about the approach chosen.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In August 2016, DEA told us they are in the process of determining the feasibility of implementing actions that would permit DEA to comply with the recommendation utilizing the current legal framework and within reasonable cost parameters. DEA also said that the large volume of DEA registrations and the large number of applications received monthly present extensive technical and fiscal challenges with addressing this recommendation. We will continue to monitor DEA's progress in implementing this recommendation.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: To ensure that DEA is best positioned to administer the quota process to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances, the Administrator of DEA should expeditiously establish formal policies and procedures to facilitate coordination with FDA as directed by the Food and Drug Administration Safety and Innovation Act, including a specific time frame in which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In June 2016, DEA stated that the agency had met with FDA to determine the specific procedures by which information regarding drug shortages will be exchanged pursuant to the Food and Drug Administration Safety and Innovation Act. DEA stated it will include these procedures in the work plan being created in response to the updated memorandum of understanding signed by FDA and DEA in March 2015. DEA officials also said that they plan to include in the work plan time frames for which DEA will be expected to respond to FDA requests to expedite shortage-related quota applications. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. As of July 2016, FDA officials said that it has completed its section of the work plan related to sharing information about drug shortages. Although GAO has been advised by DEA that the workplan has not been finalized, in August 2017, FDA stated that it and DEA are actively sharing information and have successfully completed numerous exchanges. GAO is continuing to monitor the status of this recommendation.
    Recommendation: To strengthen DEA's and FDA's ability to respond to shortages of drugs containing controlled substances, the Administrator of DEA and the Commissioner of FDA should, either in the MOU or in a separate agreement, specifically outline what information the agencies will share, and time frames for sharing such information, in response to a potential or existing drug shortage.

    Agency: Department of Justice: Drug Enforcement Administration
    Status: Open

    Comments: In March 2015, DEA and FDA updated the MOU to establish procedures regarding the exchange of proprietary and other sensitive information between the two agencies. The MOU calls for the development of separate plans to specify what information is to be shared and who it is to be shared with. Since establishing the MOU, DEA said that it had met with FDA to determine the specific procedures for sharing information about drug shortages and a draft work plan has been circulated between the two agencies for comment. GAO is continuing to monitor the status of this recommendation.