January 17, 2019
“The FDA is focused on addressing one of the largest global public health threats—antimicrobial resistance (AMR)—for this generation and generations to come. In recent years, we’ve taken policy steps to sharply reduce the use of antibiotics in animal feed. We’re also taking new steps to better facilitate product development, promote product stewardship, support antimicrobial resistance surveillance, and advance regulatory science. We recently announced a comprehensive strategy to combat AMR that will guide our work in the coming years. Part of this plan includes improving the ability of health care professionals to detect whether bacteria or fungal pathogens have developed resistance to antimicrobial drugs, including novel drugs. Having the appropriate diagnostic tools available in a timely manner will help to promptly identify the right treatment for individual patients, reduce the use of broad spectrum antibiotics when more targeted therapies are appropriate, and preserve the effectiveness of antimicrobial drugs and reduce the spread of antimicrobial resistant pathogens that can put people’s lives at risk. Antimicrobial Susceptibility Test devices can help determine when bacterial or fungal infections are likely to respond to a specific antimicrobial drug or if the pathogen has developed resistance to a certain antimicrobial drug. This assists health care professionals in choosing the right treatment for the specific infection, which can help save lives and promote recovery,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s guidance is part of our comprehensive strategy for reducing antimicrobial resistance. It outlines how drug and device developers can coordinate their product development efforts to help facilitate the timely development and availability of diagnostic devices that can test organisms for antimicrobial susceptibility so they can be available at the same time or very shortly after approval of a new antimicrobial drug. This efficient regulatory approach means labs will be able to detect antimicrobial resistance sooner, allowing health care professionals to tailor a patient’s treatment in a way that best targets the infection.”
The U.S. Centers for Disease Control estimates that, in the U.S. alone, every year at least 2 million people develop serious infections caused by antimicrobial-resistant pathogens, like Methicillin-resistant Staphylococcus aureus, and at least 23,000 people die as a direct result of these infections. The FDA recently outlined its strategic plan for combatting antimicrobial resistance and today issued final guidance titled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibly Test (AST) Devices,” in order to facilitate the availability of AST devices in a timely manner once a new antimicrobial drug is approved. The guidance provides recommendations to the medical device and drug industries on how to work together to facilitate harmonized clearance or approval by the FDA.
Specifically, the guidance describes suggested interactions between drug sponsors and device manufacturers which promote the coordinated development of a new antimicrobial drug and an AST device, explains considerations for submitting separate applications to the FDA’s Center for Drug Evaluation and Research and its Center for Devices and Radiological Health when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval, and clarifies that this approach does not change the FDA’s review process and does not influence the Medical Device User Fee Amendments and Prescription Drug User Fee Amendments review timelines for either product.
Coordinated product development of antimicrobial susceptibility test devices and antimicrobial drugs may facilitate efficient premarket review of such devices and in turn impact the timely availability of these products to both patients and health care providers. For example, this coordination has resulted in AST devices being available almost immediately or within weeks of three recent new drug approvals.
- Final Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibly Test Devices
- Antimicrobial Resistance Information from FDA
- September 2017 Public Workshop: Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices
- September 2016 Public Workshop: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.