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    Subject Term: Antibiotics

    2 publications with a total of 8 open recommendations
    Director: John Neumann
    Phone: (202) 512-3841

    6 open recommendations
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS neither agreed nor disagreed with this recommendation, and as of July 2017, we await action from FDA.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic use in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for collecting farm-specific data on antibiotic use in farm animals and antibiotic resistant bacteria by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic-resistant bacteria in food animals.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, the Animal and Plant Health Inspection Service stated that it will develop performance measures and targets for laboratory monitoring for antibiotic resistance of pathogens by September 30, 2017.
    Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

    Agency: Department of Agriculture
    Status: Open

    Comments: USDA agreed with this recommendation. In July 2017, USDA's Animal and Plant Health Inspection Service agreed to work with USDA's Food Safety and Inspection Service and HHS' Centers for Disease Control and Prevention to develop an additional decision matrix by December 31, 2017 for use to determine when on-farm antimicrobial resistance investigative activities are warranted.
    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.