Continuous Marketing Applications: Experiences of Three Biotechnology Companies

Abstract

The continuous marketing application, pilot 1 of the Prescription Drug User Fee Act 3, is a program available for drugs and biologics that have received fast-track designation. The application allows for submission of reviewable units with the goal of enabling new, innovative therapies for severe and life-threatening illnesses to gain marketing approval faster. Three biotechnology products have been approved under this program. Two companies submitted two reviewable units, and one company submitted five reviewable units. In each case, the units were submitted rapidly so that the time between the submission of the first and final units was approximately 6 months. The continuous marketing application was useful but required precise planning and ongoing discussion with the Food and Drug Administration. Because the program was a pilot program, some recommendations are given to improve its utility. The three companies would be willing to use pilot 1 again based on resource allocation benefits for the company and potential staggering of comments from the Food and Drug Administration.