Against a backdrop of doubt about the regulators’ outlook for bacteriophage therapeutics, FDA is assuring drug developers the re-emerging modality is firmly on the table. The position should assuage at least some concerns in a field grappling with questions about how to develop multi-agent cocktails, and test the products in the clinic.
At a public workshop co-sponsored by FDA and NIH’s National Institute of Allergy and Infectious Diseases (NIAID) last month, FDA officials outlined key scientific and regulatory issues for bacteriophage therapies, while seeking to allay fears that the bacteria-targeting viruses, known as "phages," would face prohibitive regulatory roadblocks.
"FDA is committed to facilitating the testing of phage therapy in clinical trials," E. Scott Stibitz told attendees. Stibitz is a principal investigator at