A Closer Look at Antibiotic Resistance

Contents
Preface
Chapter 1
Antibiotic Resistance:  Additional Federal Actions Needed  to Better Determine Magnitude  and Reduce Impact(
	Abbreviations
	Why GAO Did This Study
	What GAO Recommends
	What GAO Found
	Background
		The National Action Plan and Federal Agency Responsibilities
	CDC Has Expanded Surveillance of Antibiotic Resistance, but Faces Challenges Determining the Magnitude of the Problem
		CDC Has Expanded Surveillance of Priority Bacteria
		The Precise Magnitude and Trends of Antibiotic Resistance  Are Unknown, in Part Because of Challenges CDC Faces in Three Areas
		Challenges in Tracking Resistance
			Challenges in Reporting Complete and Timely Information on Magnitude and Trends
			Challenges in Tracking and Assessing the Global Threat
	Federal Agencies Have Helped Advance Diagnostic Tests and Promoted Their Use,  but These Efforts Have Limitations
		Agency Efforts toward the Development and Use of
		Diagnostic Tests
			HHS and DOD Have Funded the Development of New Tests
			HHS Has Funded Some Studies of Clinical Outcomes, but Has Not Clearly Identified Leadership, Roles, and Responsibilities
			CMS and FDA Have Taken Steps to Advance the Use of Tests, but Experts Have Identified Challenges with Payments
		FDA Efforts to Advance the Development of New Tests
			FDA Has Taken Steps to Speed the Development of Tests for Newly Approved Antibiotics
			FDA Has Taken Steps to Improve Breakpoint Recognition
			FDA Has Taken Limited Steps to Monitor Use of Updated Breakpoints
	Federal Efforts Have Not Fully Addressed Challenges to Developing New Treatments for Antibiotic­Resistant Infections
		Economic and Other Challenges to Developing New  Treatments Exist
		Federal Agencies Have Made Some Progress toward Addressing Treatment Development Challenges
			Federal Funding for Antibiotic R&D
			Issued Guidance to Support Clinical Trials
			Implemented Medicare Payment Mechanisms
		Federal Efforts Have Not Fully Incentivized Antibiotic Development, and HHS Lacks a Strategy to Develop  New Incentives
	Federal Agencies Have Undertaken  Several Efforts to Promote the  Appropriate Use of Antibiotics,  but Key Challenges Remain
		Federal Agencies Have Undertaken Several Efforts to  Promote the Appropriate Use of Antibiotics through Stewardship Programs
			Published Requirements for Hospitals, Long-Term Care, and DOD and VA Facilities to Implement Antibiotic Stewardship Programs
			Developed Incentives for Clinicians to Implement Antibiotic Stewardship Activities
			Published Guidance on Implementing Antibiotic  Stewardship Programs
			Expanded the Collection of Antibiotic Use Data
			Developed Antibiotic Stewardship Training for  Various Health Care Settings
			Funded Research
			Continued National Public Awareness Campaign
			Collaborated Internationally
		Four Key Challenges Have Limited Federal Efforts  to Promote the Appropriate Use of Antibiotics
			Federal Requirements and Incentives Are Limited
			CDC Faces Challenges in Collecting Complete Antibiotic Use Data, Limiting the Agency’s Ability to Monitor and Improve Appropriate Use
			The CARB Task Force Has Not Identified Plans to Address Challenges Related to Expanding Stewardship Programs  and Antibiotic Use Data Collection
			Antibiotic Stewardship Training May Have Limited Success  in Improving Prescribing Behavior
	Conclusion
	Recommendations for Executive Action
	Agency Comments and Our Evaluation
	Appendix I: Objectives, Scope,  and Methodology
	Appendix II: Expert Meeting Participant List
	Appendix III: Additional Examples of Federal Efforts to Support Antibiotic Research  and Development
	Appendix IV: Additional Information on Federal Efforts to Promote Appropriate Antibiotic Use
	Appendix V: Comments from the Department  of Health and Human Services
Chapter 2
Combating Superbugs:  U.S. Public Health Responses to Antibiotic Resistance(
	Opening Statement of Hon. Tim Murphy,  a Representative in Congress from the Commonwealth of Pennsylvania
	Prepared Statement of Hon. Tim Murphy
	Opening Statement of Hon. Diana Degette,  a Representative in Congress  from the State of Colorado
	Opening Statement of Hon. Fred Upton,  a Representative in Congress  from the State of Michigan
	Opening Statement of Chairman Fred Upton Subcommittee on Oversight and Investigations Hearing on “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance,”  June 14, 2016
	Opening Statement of Hon. David B. Mckinley,  a Representative in Congress from the State  of West Virginia
	Opening Statement of Vice Chairman McKinley Subcommittee on Oversight and Investigations Hearing on “Combatting Superbugs: U.S. Public Health Responses to Antibiotic Resistance,”  June 14, 2016
	Opening Statement of Hon. Frank Pallone, Jr.,  a Representative in Congress  from the State of New Jersey
	Statements of Dr. Beth Bell, Director,  National Center for Emerging and Zoonotic Infectious Disease, Centers for Disease Control; Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration; Dr. Richard J. Hatc...
		Statement of Dr. Beth Bell
	Witness: Beth Bell, MD, MPH;  Testimony: House Energy and Commerce Committee, Subcommittee on Oversight  and Investigations
		Threat of Antibiotic Resistance
		CDC’s Antibiotic Resistance Solutions Initiative
		Detect and Respond
		Prevent
		Innovate
		Collaborate
		Additional Investments
		Public Health Response to Discovery of mcr-1
		Conclusion
	Statement of Dr. Janet Woodcock
	Statement of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research Food and Drug Administration, Department of Health and Human Services, before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. ...
		Introduction
		The Challenges Impacting Antibacterial Drug Development
		Use of Common Clinical Trial Protocols to Encourage Antibacterial Drug Development
		What FDA Is Doing to Address the Current Challenges
		Encouraging the Development of New Antibacterial Drugs
		Accelerating Development of Rapid Diagnostic Tests  for Antibiotic Resistance
		Expedited Updating of Susceptibility Test Interpretive Criteria (Breakpoints) to Maximize the Effective Use  of Antimicrobial Products
		Solution for Updating Breakpoint Information Faster
		Conclusion
	Statement of Dr. Richard J. Hatchett
	Written Testimony, House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, “Combatting Superbugs:  U.S. Public Health Responses to  Antibiotic Resistance”
	Statement of Dennis M. Dixon
	Department of Health and Human Services National Institutes of Health, The Role of the National Institute of Allergy and Infectious Diseases Research in Combating Antibiotic Resistance, Testimony before the House Energy and Commerce Committee, Subcomm...
		Antibiotic Resistance
		White House Initiative on Combating  Antibiotic-Resistant Bacteria
		NIAID Research Addressing Antibiotic Resistance
			Basic Research and Research Resources to Facilitate  Product Development
			Diagnostics
			Therapeutics
			Vaccines
		Conclusion
	U.S. House of Representatives, Committee on Energy and Commerce, June 10, 2016
		Witnesses
		Background
			Understanding the Superbug and Antibiotic Resistance
			Overuse of Antibiotics
			Development of New Antibiotics
			The Federal Response to Antibiotic Resistance
				Mapping the Spread of Antibiotic-Resistant Bacteria
				Antibiotic Stewardship Programs
				New Antibiotic Development
		Issues
Index
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