The FDA, pharmaceutical companies and device manufacturers are looking to close the lag time between approvals of new antibiotics and 510(k) clearance of related antimicrobial susceptibility tests, which assist clinicians in determining which drug and dosage to select for treatment.
At an FDA workshop, industry representatives called for simultaneous approvals, an expedited regulatory pathway for the devices — similar to what has already been done with the Fast Track designation in drug development.
The GAIN Act, passed by Congress in 2014, includes prioritized review and marketing exclusivity for qualified antibiotics applications. But in the clinical setting, some physicians are reluctant to prescribe new antibiotic treatments without the results of a related test.
“New drugs are coming, and that’s great,” said Amy Mathers, an associate professor at the University of Virginia, at the workshop Sept. 29. “But it’s really hard to use these drugs when you don’t have susceptibility testing.”
The FDA recently published draft guidance encouraging coordinated development of the drugs and tests, including early and frequent communication with both CDER and CDRH. The agency stressed that it is pursuing coordinated development, not co-development, and that the process would be different from the approval process for in vitro companion diagnostic tests ().