Administration Moves to Address Antibiotic Resistance

On September 18, 2014, the Obama administration announced a comprehensive initiative to combat the growing threat of antibiotic-resistant bacteria. The initiative centers largely on preventing overuse of antibiotics and encouraging the development of new treatments. The administration's response to this pressing public health problem includes the following key components:

• An Executive Order (EO 13676) that establishes a task force and a Presidential Advisory Council for Combating Antibiotic-Resistant Bacteria, among other things
• A Report to the President on Combating Antibiotic Resistance, from the Presidential Council of Advisers on Science and Technology (PCAST)
• A National Strategy for Combating Antibiotic-Resistant Bacteria, developed by the National Security Council (NSC) and the White House Office of Science and Technology Policy (OSTP)
• An initiative to award a $20 million prize for development of tests to identify antibiotic-resistant bacteria

Key Steps Taken

The Executive Order directs federal departments and agencies to implement the National Strategy. It also creates a new Task Force — co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services — and a Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria that will provide timely advice, information and recommendations to the field. The National Strategy provides a five-year plan for addressing the PCAST report, including five national goals to:

• Slow the emergence and prevent the spread of resistant bacteria
• Strengthen national efforts to identify and report cases of antibiotic resistance
• Advance development and use of rapid diagnostic tests for the identification and characterization of antibiotic-resistant bacteria
• Accelerate basic and applied research and development for new antibiotics as well as other therapeutics and vaccines
• Improve international collaboration, capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development

In additional to the National Strategy, the long-awaited PCAST Report includes specific recommendations for action steps that can be taken to combat antibiotic resistance. Additionally, the administration will launch a $20 million prize — co-sponsored by the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) — to incentivize the creation of a rapid, point-of-care diagnostic test that will help to identify highly-resistant forms of bacteria.

Implications for Health Care and Agriculture Sectors

These efforts by the Obama administration have broad implications for the health care field — from patients to providers and academia to industry. The issue of antibiotic overuse is a common theme throughout the administration's push to address resistance. Educational efforts about the appropriate use of antibiotics are aimed at patients who demand antibiotics and providers who prescribe them. The PCAST report goes as far as recommending that all U.S. hospitals participating in Medicare establish an antibiotic-stewardship program in order to receive federal reimbursement. For innovators in both the private and academic sectors, the race is on to better understand, prevent and address "superbugs" as they arise around the globe.

The agriculture industry, particularly livestock producers and veterinarians, play an important role in combating antibiotic-resistance. The PCAST Report contains two sections on "Stewardship of Current Antibiotics" — one for "Human Health Care" and another for "Animal Agriculture." Antibiotics are used extensively in animal agriculture. The PCAST report acknowledges this, and goes on to say that while disease prevention in animals is a laudable goal, the benefits of antibiotic use in animal agriculture should be weighed against the potential risks to human health. The production-related (growth) use of antibiotics in animals, in particular, has come under a great deal of scrutiny as the concern about antibiotic resistance, and the extent to which such use in animals may contribute, has risen.

Additional Developments

These developments from the administration complement a growing sense of urgency around antibiotic resistance in the U.S. and Congress, as well as internationally.

Just last week, three U.S. Senators, led by Dianne Feinstein (D-CA), sent a letter to President Obama, encouraging him to request $15 million for the FDA National Antimicrobial Resistance Monitoring System (NARMS) in the FY 2016 budget request. On September 19, 2014, the House Energy & Commerce Subcommittee on Health explored the issue as part of its ongoing 21st Century Cures initiative. The hearing explored the growing threat of antibiotic-resistant bacteria, as well as incentives that would drive innovation to address this threat. Additionally, there have been several bills introduced in both the House and Senate during the 113th Congress that aim to address antibiotic resistance.

In April 2014, the World Health Organization (WHO) issued its Global Report on Surveillance with recommendations for enhanced global surveillance of antimicrobials, and cautioned that we may be moving toward a "post-antibiotic era" unless dramatic changes occur. In April 2013, the U.S. Centers for Disease Control and Prevention (CDC) called for caution in the prescription and use of antibiotics in humans in their report: Antibiotic Resistance Threats in the United States, 2013.

In December 2013, the U.S. Food and Drug Administration (FDA) took steps to address the use of antibiotics for growth-promotion purposes in animal agriculture by issuing a proposed rule that would amend Veterinary Feed Directive (VFD) guidelines to require a prescription from veterinarians, and Guidance for Industry (GFI) 213, which instructs antimicrobial drug manufacturers to remove production-related claims from their product labels. The animal health industry has responded well to the actions by FDA and is continually collaborating with the agency to ensure judicious use of antibiotics in animal agriculture.

In addition to these actions by FDA, the Executive Order instructs FDA to continue taking steps to eliminate the agricultural use of medically-important antibiotics for growth-promotion purposes and, among other things, directs the new Advisory Council to provide advice, information and recommendations on developing alternatives to the use of antibiotics for such uses.

FaegreBD Consulting's health and biosciences and food and agriculture sector teams are monitoring developments around antibiotic resistance. Our professionals would be pleased to speak with you about ways that the administration's recent efforts, and other federal initiatives on antibiotic resistance, may impact your business and community.