by Kenneth V. Phelps, President/CEO
Camargo Pharmaceutical Services
Time is money – a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars. Avoidance of costly and time-consuming clinical trials is, therefore, quite desirable for drug companies in the race to bring products to the marketplace before competition. A 505(b)(2) application might then offer an appealing regulatory pathway alternative. This route permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the agency's findings for a previously approved drug.
Created in 1984 as part of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, the 505(b)(2) application is intended to encourage sponsors to develop innovative medicines using currently available products. According to Section 505(b)(2) guidelines, an NDA approval can be obtained for a new drug without conducting the full complement of safety and efficacy trials and without a "right of reference" from the original applicant.
The 505(b)(2) application is one of three types of NDAs that can be submitted to the FDA. A full NDA is "an application that contains full reports of investigations of safety and effectiveness," according to Section 505(b)(1). Data found in a full NDA must be from studies conducted by or for the sponsor, or must be obtained through a "right of reference." An abbreviated NDA (ANDA) is for a proposed drug that is identical to a reference listed drug and must demonstrate its bioequivalence. In a sense, the 505(b)(2) was intended to be a hybrid of the full NDA and an ANDA: it proposes a limited change to a previously approved product, but demonstrates the required safety and efficacy of the change.