WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14.
“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said.
The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:
- Facilitating product development.
- Promoting antimicrobial stewardship.
- Supporting the development of new tools for surveillance.
- Advancing scientific initiatives, including research for the development of alternative treatments.
The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized.
Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services.
Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well.
The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.
Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.
To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added.
As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.
“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded.
In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR.
William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena.
“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added.
Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.
Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance.
Dr. Gottlieb and the panelists had no financial conflicts to disclose.
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