Regulatory disincentives for developing antibiotics for common indications.
Pediatric and adult community-acquired respiratory tract infections remain some of the most common reasons for visits to primary care practitioners, and the antibiotics used to treat them are historically highly profitable for their manufacturers. Despite these facts and the continued evolving need for new treatments for these infections, virtually no new agents have been developed in the past decade. This review explores some regulatory guidelines that could potentially explain the dearth of development, and it provides some practical answers for resolving them.
Amsden
Guy W
GW
Department of Pharmaceutical Care Services, Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326, USA. guy.amsden@bassett.org