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FDA Announces New Plan to Fight Antimicrobial Resistance

SEP 17, 2018 | BRIAN P. DUNLEAVY
The US Food and Drug Administration (FDA) declared war on antimicrobial resistance (AMR) on September 14, announcing a comprehensive plan to combat arguably the biggest public health challenge facing the country.

By now, of course, everyone working within the field of infectious diseases knows the much-discussed figures provided by the US Centers for Disease Control and Prevention (CDC). Those numbers suggest that some 2 million Americans fall ill annually as a result of infections caused by antimicrobial-resistant pathogens; an estimated 23,000 of them die.

FDA commissioner Scott Gottlieb, MD, is hardly sanguine about reducing these numbers in the short-term, but he believes he and his colleagues within the FDA understand the best pathway forward.

“You’re all here today because you understand the importance of addressing antimicrobial resistance to maintain and advance the tools of modern medicine,” he told an audience gathered at the Pew Charitable Trusts in Washington, DC, for the agency’s announcement. “Not only for this generation, but for many generations to come. We can’t count on outracing drug resistance. But we can use stewardship and science to slow its pace and reduce its impact on human and animal health. To do so, we need an all-hands-on-deck approach to combating AMR in both human and veterinary settings. We need an all-of-the-above strategy.”

In presenting its 2019 Strategic Approach for Combating AMR, the FDA appears to be offering a 3-tiered strategy—one that starts with somewhat novel approaches for stimulating new antimicrobial development. Although Dr. Gottlieb lauded the accomplishments of “push”-style incentive programs such as the Generating New Antibiotics Now (GAIN) Act and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) in generating new drug research and development, he noted that in spite of these efforts only 11 antibiotic products that are designed to address the most-threatening pathogens, as identified by the World Health Organization, are currently in clinical trials. He thus advocated for stronger “pull” incentives, including the creation of a new reimbursement model that would use milestone payments and subscription fees for new FDA-approved antibiotics with demonstrable clinical and social value—including those that tackle resistant pathogens.

“If we want to maintain a robust pipeline for antibiotics, it is necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains—without weakening antibiotic stewardship,” Dr. Gottlieb explained. “It is important to pursue new policies and reimbursement approaches now, to shift the investment landscape right away. And it is important to develop these products now, so they’ll be available when we need them later. One constructive way to start would be to develop innovative payment mechanisms that allow companies to capture a greater upfront share of the social value of antibiotic drug development.”

Part of the FDA’s plan also includes enhanced stewardship initiatives in veterinary medicine. As part of the strategy announced by Dr. Gottlieb, the FDA’s Center for Veterinary Medicine released a 5-year action plan that would govern the use of “medically important antimicrobials” by bringing “all remaining therapeutic uses of these drugs under the oversight of licensed veterinarians” and bolster “the judicious use of antimicrobials in food-producing animals.” The approach called for applying a “risk-based approach” to the evaluation of both new and currently approved antimicrobials for animals and collecting data on resistance and antimicrobial use in veterinary medicine.

The last portion of the FDA’s new strategy entails an expansion of the National Antimicrobial Resistance Monitoring System (NARMS), which is designed to track drug resistance in Salmonella, Escherichia coli, and other harmful foodborne bacteria. The augmented NARMS platform will now include previously underexplored bacteria and other pathogens found in companion animals and animal feed. Meanwhile, in human populations, the FDA will be continuing to work with the CDC to improve data collection for and reporting of AMR pathogens through the development of SHIELD (Systemic Harmonization and Interoperability Enhancement for Lab Data) approach.

“Reducing inconsistency in reporting test results should substantially improve the reporting of antimicrobial resistance,” Dr. Gottlieb noted. “Continued development of this program… should unlock the ability for real-time clinician support across all electronic health record systems. It’ll enable efficient tracking of prevalence and spread of AMR within and across institutions. And, it’ll also advance the development of real-world evidence for different treatment approaches. Our Office of In Vitro Diagnostics and our drug center colleagues have also published a draft guidance [to]… facilitate the availability of diagnostic devices to test organisms for antimicrobial susceptibility at the same time or very shortly after approval of a new antimicrobial drug. We’ll be working to finalize this guidance soon.”
 
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous health care-related publications. He is the former editor of Infectious Disease Special Edition.
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