FDA Draft Guidance Addresses Coordinated Development Of AST Devices, Antimicrobial Drugs
FDA has published a draft guidance for industry outlining the agency’s approach to the coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices. Though the agency wishes to better facilitate interactions between drug sponsors and device developers, FDA emphasized that applications will remain separate, and review timelines for separate products will not be influenced by each other.
The goal of AST devices is to monitor possible drug resistance in common pathogens and ensure susceptibility to antimicrobial drugs indicated to treat the particular infection. In a review published in Clinical Infectious Diseases, researchers wrote that pathogens continually are evolving, as are antimicrobial resistance mechanisms. “Newer or emerging mechanisms of resistance require constant vigilance regarding the ability of each test to accurately detect resistance.”
In the draft guidance, FDA wrote that AST devices play an important role in informing the correct usage of antimicrobial drugs, helping researchers identify new mechanisms of drug resistance, and monitoring the overall population changes in a pathogen’s susceptibility to particular drugs. Though the development of these devices and new antimicrobials traditionally has been separate, FDA noted that better coordination of the development of both drugs and tests offers benefits to both patient and industry.
“Drug sponsors may benefit by having access to AST device technology that may be valuable during clinical studies,” wrote the FDA. “AST device manufacturers may similarly benefit by having access to clinical samples and isolates obtained during the drug development that may aid in validation of the device.” Better cooperation between companies in the earliest stages of development could potentially expedite access to these devices.
If proceeding with coordinated development, FDA recommends that drug sponsors and AST device manufacturers each develop a coordination plan, and then submit those plans to the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), respectively. Both companies may request meetings with the FDA to address possible concerns. In order to achieve coordinated review timelines, FDA recommended that applications for AST devices be submitted as early as possible.
FDA recently released two other related guidances. One is a draft guidance that clarifies the agency’s position microbiological data collection for new antimicrobial drug products, and the other a guidance update that addresses particular challenges and concerns facing developers of new AST systems. The agency emphasized that AST systems should not be confused with in vitro companion diagnostic devices, outlined in a guidance released last month.
On Sept. 29, 2016, the agency will host a panel to discuss coordinated development in greater detail. Panelist will include representatives from both the CDER and CDRH, as well as representatives from the U.S. Centers for Disease Control (CDC) and several academic research institutions.
United Nations member countries attending the U.N. General Assembly in New York recently drafted resolutions pledging to take more aggressive steps to counter the spread of drug-resistant “super-bugs,” reported Reuters.
“Antimicrobial resistance poses a fundamental threat to human health, development and security,” said Margaret Chan, director-general of the World Health Organization (WHO). “The commitments made today must now be translated into swift, effective, lifesaving actions across human, animal and environmental health sectors. We are running out of time.”
According to the Washington Post, leading pharmaceutical companies — including J&J, Novartis, and Pfizer — presented a collaborative roadmap and series of commitments to reducing drug resistance by 2020.