FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

Abstract

The US Food and Drug Administration’s (FDA’s) Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy programs have been successful in facilitating the drug approval process and getting medications to patients quicker. To qualify for one or more of these FDA programs, a sponsor must meet specific criteria. Once a drug is given one or more designations, benefits can range from frequent meetings with FDA representatives to appointed FDA senior managers to facilitate the approval process. This paper will review the major guidelines set forth by the FDA, highlight advantages to the patient and health care community as a result of receiving specific designations, and provide several examples for illustration. As a result of these designations, many patients with rare diseases or life-threatening conditions have been afforded earlier access to effective therapies. As the pharmacist’s role continues to expand, it is crucial to understand the nature of these accelerated programs and to advocate for increased access to new drug therapies.