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    Subject Term: "Pharmaceutical industry"

    12 publications with a total of 22 open recommendations including 1 priority recommendation
    Director: Dicken, John E
    Phone: (202)512-7114

    1 open recommendations
    Recommendation: To ensure efficient use of generic drug user fees, facilitate oversight and transparency, and plan for risks, the Commissioner of FDA should develop a plan for administering user fee carryover that includes analyses of program costs and risks and reflects actual operational needs and contingencies.

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

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Director: John E. Dicken
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should clarify how drug sponsors should utilize draft guidance documents that were released in accordance with GAIN.

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

    Comments: HHS gave GAO information on its Good Guidance Practices, which provide that guidance documents are not binding on FDA or the public and that sponsors can use alternative approaches consistent with applicable statutes. HHS also noted that FDA issues guidance in draft form to solicit public comment before finalizing its current thinking and recommendations. This practice, as reflected by language on applicable QIDP draft guidance documents indicating that the guidance will represent FDA's current thinking "when finalized," created uncertainty for sponsors in planning their antibiotic drug development programs. Without clarifying the role of draft guidance in the QIDP designation and process, this uncertainty will continue to persist. GAO considers this recommendation open.
    Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

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

    Comments: According to HHS, FDA intends to begin developing guidance on the QIDP designation and will eventually make this guidance publicly available.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    2 open recommendations
    including 1 priority recommendation
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

    Comments: HHS concurred with this recommendation and stated that FDA plans to conduct internal annual reviews of its foreign offices' performances and track their contributions by type of commodity. We will assess these actions once they have been completed.
    Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its OIP strategic workforce plan, the Commissioner of FDA should establish goals to achieve the appropriate staffing level for its foreign offices, which would include separating foreign office vacancies from the OIP-wide vacancy rate, and setting goals by position type.

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

    Comments: HHS concurred with this recommendation. HHS said that the strategic workforce plan for FDA's foreign offices will be updated to reflect the disaggregation of performance measures that track foreign office vacancy rates and targets by position type. We will assess these actions once they have been completed.
    Director: John Dicken
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Executive Director of NCD should assign responsibilities for conducting future campaign activities and develop an evaluation plan for its activities.

    Agency: National Council on Disability
    Status: Open

    Comments: As of July 2017, the National Council on Disability (NCD) had developed a plan for conducting campaign activities that had assigned responsibilities. However, as a result of recent changes in leadership and staff, several key activities do not have staff assigned and will need to be updated to ensure responsibility for completing the plan. Additionally, NCD said that they plan to conduct an internal audit in December 2017 to monitor the progress of their activities. While this audit is helpful in identifying progress to date, our recommendation suggests that NCD should also plan to evaluate the effectiveness of its activities.
    Director: Debra A. Draper
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To be able to identify and address problems that may occur and thus help ensure a smooth transition, the Secretary of Defense should require the Defense Health Agency ensure that planning documents for the expansion include specific requirements to continuously monitor affected beneficiaries, including whether (1) covered medications are available and filled in a timely and accurate manner through mail order and across MTF pharmacies; and (2) beneficiaries are satisfied with the transition to mail order and MTF pharmacies.

    Agency: Department of Defense
    Status: Open

    Comments: As of April 2016, DOD has not provided information that it plans to separately track through mail order and military treatment facilities the availability, timeliness, and accuracy of prescriptions filled by beneficiaries affected by the expansion of the TRICARE pharmacy pilot. Similarly, DOD has not provided information that it plans to separately track through mail order and military treatment facilities the satisfaction of beneficiaries affected by the expansion of the TRICARE pharmacy pilot.
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to modify the voluntary reporting form FDA uses to obtain information on adverse events to ask whether drugs involved in adverse events were compounded.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA has drafted a notice for publication in the Federal Register that seeks comment on editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. The publication of the notice was issued in July 2017. After a 60-day public comment period, the revisions to Form FDA 1932a will be submitted to OMB for review and approval under the Paperwork Reduction Act.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2017, FDA notified us that they are still in the process of developing guidance for agency staff that specifies circumstances under which FDA will enforce compounding regulations for animals. According to FDA, the agency received more than 150 comments regarding the draft Guide For Industry #230 and 280 nominations of bulk drug substances for use in compounding office stock; information necessary for updating the guidance. In addition, FDA is reviewing the substances that were nominated for use in compounding office stock. Officials did not provide a specific timeline for completing this work, but stated that developing updated guidance on compounding for animals continues to be a high priority for FDA.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA reported that it is still developing an enforcement strategy for compounded animal drugs that includes a process for documenting the Agency's actions with respect to follow-up on warning letters, adverse event reports, and complaints.
    Director: Linda Kohn
    Phone: (202) 512-7114

    3 open recommendations
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should identify and implement means of cost-effective, regular communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: As of March 2017, DEA officials reported that the agency was taking steps towards addressing this recommendation. In particular, DEA officials reported that they were in the process of developing a method to deliver information about registrant responsibilities through DEA's registration website, which registrants could access annually when they update their registration. DEA officials also reported that they would consider a method for registrants to subscribe to get email updates when new information is posted to Diversion Control Division website. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In March 2017, DEA officials reported that the agency had worked with its Suspicious Orders Task Force to develop a draft Suspicious Orders regulation. They reported that the draft regulation was undergoing internal DEA review, but that it was uncertain when the draft regulation would be published in the Federal Register. We plan to continue to monitor the agency's efforts in this area, and this recommendation remains open.
    Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

    Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
    Status: Open

    Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In March 2017, DEA officials reported that while an update to the Pharmacist's Manual was still under way, they did not have an estimated completion date. We plan to continue to monitor the agency's efforts in this area, as well, and consequently this recommendation remains open.
    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.
    Director: Marcia Crosse
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

    Comments: In August 2017, FDA reported that it had not conducted any rigorous analysis of predictors of drug shortages nor have new drug risk factors been identified. Although FDA adopted a new, commercially developed data system, the "Shortage Tracker" to track drug shortages in March 2016, it is used to help the Drug Shortage Staff manage their workload. FDA reported that this system has now been fully operational for over a year. However, no trend analysis relating to drug shortages has been conducted and the agency has no plans to conduct such analyses at this time.
    Director: Dicken, John E
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: The Secretary of HHS should direct the Administrator of CMS to monitor the relationship between PPACA-based FULs and the NADACs on an ongoing basis to help determine whether PPACA-based FULs effectively control federal Medicaid expenditures without reducing beneficiary access to drugs subject to FULs over time.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As part of the final rule implementing the PPACA-based FUL formula, CMS monitors the relationship between the FUL and the NADAC for individual drugs on an ongoing basis and ensures that the FUL does not fall below the NADAC. CMS, however, does not monitor the relationship between the FUL and NADAC in aggregate. This monitoring would provide CMS information on the extent to which the FUL effectively controls federal Medicaid expenditures, particularly in cases where there may be potential for over-reimbursement. CMS officials expect that, by mid-2017, many states will determine reimbursement using an average acquisition cost based on the NADAC. As a result, any potential variation between the FUL and NADAC would be reduced according to CMS officials. We plan to obtain state plan amendments from CMS to confirm whether states are reimbursing at an average acquisition cost or using some other methodology to control Medicaid expenditures.
    Director: Draper, Debra A
    Phone: (202) 512-3000

    2 open recommendations
    Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to finalize new, more specific guidance on the definition of a 340B patient.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In January 2017, HRSA withdrew proposed guidance that included further specificity on the definition of 340B patient in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register.
    Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to issue guidance to further specify the criteria that hospitals that are not publicly owned or operated must meet to be eligible for the 340B program.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In January 2017, HRSA withdrew proposed guidance that included additional specificity regarding hospital eligibility in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register.
    Director: Cosgrove, James C
    Phone: (202)512-7029

    2 open recommendations
    Recommendation: To help ensure that Medicare beneficiaries have access to high-quality dialysis care, the Administrator of CMS should assess the extent to which the bundled payment for dialysis care will be sufficient to cover an efficient dialysis organization's costs to provide such care when the bundled payment expands to cover oral-only ESRD drugs. The Administrator should conduct this assessment before implementing this expanded bundled payment.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
    Recommendation: In order to ensure effective monitoring of treatment of mineral and bone disorder, the Administrator of CMS should continue collecting data for quality measures related to this condition from sources such as the Elab Project until CROWNWeb is fully implemented and concerns about its data reliability have been adequately addressed.

    Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.