Antibiotic Resistance:

Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact

GAO-20-341: Published: Mar 30, 2020. Publicly Released: Apr 29, 2020.

Multimedia:

  • PODCAST: Antibiotic Resistance

    The rising rate of antibiotic-resistant bacterial infections poses a serious health threat to Americans. Tim Persons and Mary Denigan-Macauley join the Watchdog Report to talk about federal efforts to get a handle on 'superbugs.'

    View the transcript

Additional Materials:

Contact:

Timothy M. Persons, Ph.D.
(202) 512-6888
personst@gao.gov

 

Mary Denigan-Macauley
(202) 512-7114
deniganmacauleym@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

Antibiotic-resistant infections can be difficult or impossible to treat.

We examined federal challenges to addressing antibiotic resistance:

Surveillance—Tracking resistant infections is tough because of reliance on sampling and voluntary reporting

Diagnostics—Lack of data on clinical outcomes impedes the development and use of antibiotic-resistance tests

New treatments—The pipeline of new antibiotics is inadequate and federal efforts haven’t fully incentivized development

Antibiotic use—Federal requirements to improve antibiotic use are mostly limited to hospitals and nursing homes

Our 8 recommendations are to strengthen federal efforts.

Pills spilling out of a prescription bottle

Pills spilling out of a prescription bottle

Multimedia:

  • PODCAST: Antibiotic Resistance

    The rising rate of antibiotic-resistant bacterial infections poses a serious health threat to Americans. Tim Persons and Mary Denigan-Macauley join the Watchdog Report to talk about federal efforts to get a handle on 'superbugs.'

    View the transcript

Additional Materials:

Contact:

Timothy M. Persons, Ph.D.
(202) 512-6888
personst@gao.gov

 

Mary Denigan-Macauley
(202) 512-7114
deniganmacauleym@gao.gov

 

Office of Public Affairs
(202) 512-4800
youngc1@gao.gov

What GAO Found

The precise magnitude of the problem of antibiotic resistance is unknown. The Centers for Disease Control and Prevention (CDC) has made progress in expanding surveillance of infections from certain antibiotic-resistant bacteria in the United States and abroad but faces several challenges.

2001-2017 Cumulative Spread of One Type of Highly Resistant Bacteria in the United States

2001-2017 Cumulative Spread of One Type of Highly Resistant Bacteria in the United States

Note: This figure tracks a type of carbapenem-resistant Enterobacteriaceae (CRE), which, according to CDC, is a “nightmare bacteria” resistant to nearly all available antibiotics. Shading indicates CDC confirmed the presence of these bacteria within that state in that year or a previous one.

CDC faces challenges in conducting surveillance for antibiotic resistance due to the limited data it is able to collect through various surveillance systems. For example, CDC's primary surveillance system for gonorrhea—which CDC classified as an urgent antibiotic resistance threat affecting over half a million patients annually—currently tracks only an estimated 1 to 2 percent of all U.S. cases and only in males. CDC has not fully evaluated the representativeness of the gonorrhea surveillance system's results. However, it could do so, for example, by comparing the trends in their limited sample population with trends it can establish in the overall U.S. population via additional studies. Such an evaluation could give CDC more confidence that the system's data accurately reflect national trends.

Federal agencies have taken steps to advance the development and use of diagnostic tests to identify antibiotic-resistant bacterial infections, but these efforts have limitations. For example, agencies have conducted some studies to establish whether testing can lead to positive health care outcomes, such as reduced rates of antibiotic-resistant infections. However, more such studies are needed, according to experts and agency officials. Without information to guide test usage, clinicians may not be able to select appropriate treatments for their patients. One reason for the insufficient number of studies is that Department of Health and Human Services (HHS) agencies that are in a position to conduct or fund such studies—such as CDC and the Biomedical Advanced Research and Development Authority—disagree about what each agency should do. By clarifying roles and responsibilities, HHS agencies could more effectively address the need for more studies. The resulting studies could help demonstrate the value of diagnostic tests for antibiotic resistance, potentially increasing their use and improving patient care.

Experts warn that the current pipeline of antibiotics in development is insufficient to meet the threat of resistance. Several challenges impede the development of new treatments for resistant infections, notably inadequate return on investment for drug companies largely due to low prices and a limited patient population for whom these treatments would be appropriate. While HHS and Department of Defense agencies have provided financial premarket incentives to support antibiotic research and development, experts, federal officials and antibiotic developers agree that more postmarket incentives are needed to overcome the economic challenges. Advisory groups, including a presidential advisory council, and others have called for new postmarket incentives and identified multiple options for their design, including market entry rewards and reimbursement reform (see figure). However, HHS has not developed a strategy to further incentivize development of new treatments for antibiotic-resistant infections, and it may need to request authority and appropriations to create and implement certain types of incentives. Until such incentives are developed, more drug companies may exit the antibiotic development sector, and the pipeline of new treatments may continue to decrease.

Examples of Possible Postmarket Incentive Options to Encourage the Development of Antibiotics Identified by Advisory Groups and Others

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Federal agencies have made several efforts to promote the appropriate use of antibiotics across health care settings through antibiotic stewardship—giving patients the right antibiotic at the right time, in the right dose, and for the right duration. However, key challenges remain. For example, federal agencies require only certain types of health care facilities to implement stewardship programs. In addition, CDC is limited in its ability to monitor and improve appropriate antibiotic use, in part because providers are not generally required to report antibiotic use data to a centralized database. The 5-year National Action Plan for Combating Antibiotic-Resistant Bacteria (National Action Plan) calls for strengthening antibiotic stewardship and for the timely reporting of antibiotic use data across health care settings. An executive order directs an interagency task force—the Combating Antibiotic-Resistant Bacteria (CARB) Task Force, coordinated by HHS—to provide annual updates to the President on, among other things, plans for addressing any barriers to full implementation of the National Action Plan. However, in its progress reports covering the first 4 years of the National Action Plan's implementation, the task force did not identify plans to address barriers to expanding antibiotic stewardship programs or the collection of antibiotic use data. Until it does so, the government will not have reasonable assurance that it is fully implementing the National Action Plan and addressing antibiotic resistance.

Why GAO Did This Study

Bacterial infections have become more difficult, and sometimes impossible, to treat due to antibiotic resistance, which occurs when bacteria develop the ability to defeat the available drugs designed to kill them. Concerns about rising rates of resistance to available treatment options prompted the federal government to create the 5-year National Action Plan in 2015. The plan called for federal agencies to strengthen surveillance, advance the development of diagnostic tests and new antibiotics, and slow the emergence of resistant bacteria, among other things.

GAO was asked to review federal efforts to address antibiotic resistance. This report examines federal efforts and challenges related to (1) surveillance of antibiotic resistance, (2) the development and use of diagnostic testing to identify antibiotic resistance, (3) the development of treatments for resistant infections, and (4) appropriate antibiotic use. GAO reviewed literature and agency documents; interviewed agency officials and health care industry, drug industry, and other stakeholders; and held a meeting of international and U.S. experts to obtain their views.

What GAO Recommends

GAO is making eight recommendations to strengthen the federal response to combating antibiotic resistance. HHS concurred with seven recommendations and did not concur with one. More details are provided on the next page.

In response to the findings presented in this Highlights, GAO recommends that:

CDC ensure that its evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of the system's representativeness of the U.S. population;

HHS identify leadership and clarify roles and responsibilities to assess the clinical outcomes of diagnostic testing;

HHS develop a strategy to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives;

HHS direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan.

In addition, GAO is making four recommendations to address other CDC efforts in surveillance and reporting and to address FDA efforts in monitoring diagnostic tests.

HHS did not concur with the recommendation that it develop a strategy that includes the use of postmarket financial incentives to encourage the development of new treatments for antibiotic-resistant infections, citing its ongoing analysis to understand whether postmarket incentives should be included in such a strategy. GAO recognizes the complexity of this issue and maintains that this recommendation is warranted given that experts and others have called for additional postmarket incentives and the insufficiency of the current pipeline of new treatments for antibiotic-resistant infections.

For more information, contact Timothy M. Persons at (202) 512-6888 or personst@gao.gov or Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.

Recommendations for Executive Action

  1. Status: Open

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

    Recommendation: The Director of CDC should take steps to determine participation rates and distribution needed in the AR Option of the National Healthcare Safety Network for conducting regional and national assessments of antibiotic resistance of public health importance. (Recommendation 1)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  2. Status: Open

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

    Recommendation: The Director of CDC should ensure that CDC's evaluation of its surveillance system for antibiotic-resistant gonorrhea includes measures of its representativeness, such as comparison of the trends in the sample population with those in the overall U.S. population, using specially designed studies if needed. (Recommendation 2)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  3. Status: Open

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

    Recommendation: The Director of CDC should provide information on uncertainties for antibiotic resistance estimates in its consolidated Threats Reports, including standard errors or confidence intervals, as appropriate. (Recommendation 3)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  4. Status: Open

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

    Recommendation: The Director of CDC should develop a plan for timely, consolidated reports of antibiotic resistance in priority pathogens at regular intervals. (Recommendation 4)

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control and Prevention

  5. Status: Open

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

    Recommendation: The Secretary of HHS should identify leadership and clarify roles and responsibilities among HHS agencies to assess the clinical outcomes of diagnostic testing for identifying antibiotic-resistant bacteria. (Recommendation 5)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

  6. Status: Open

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

    Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner

  7. Status: Open

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

    Recommendation: The Secretary of HHS should develop a strategic framework to further incentivize the development of new treatments for antibiotic-resistant infections, including through the use of postmarket financial incentives, and, if appropriate, make recommendations to Congress for necessary authority. (Recommendation 7)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

  8. Status: Open

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

    Recommendation: The Secretary of HHS should direct the CARB Task Force to include in its annual updates to the President plans for addressing any barriers preventing full implementation of the National Action Plan and, as appropriate, make recommendations for new or modified actions. Specifically, the CARB Task Force should identify plans to address barriers, such as those related to expanding (1) a CDC program designed to strengthen the U.S. response to resistant gonorrhea; (2) antibiotic stewardship programs across health care settings; and (3) antibiotic use data collection across health care settings, to the extent feasible. (Recommendation 8)

    Agency Affected: Department of Health and Human Services: Office of the Secretary

 

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