505(b)(2) Applications: History, Science, and Experience
In 1984, the 505(b)(2) application route for a New Drug Application was created by Congress to allow applicants to create innovative medicines using currently available products without performing a full complement of safety and efficacy studies. This article reviews the history of the approach, provides examples, and considers some of the scientific and technical challenges associated with documenting safety and efficacy relative to the proposed change. The approach does not appear to have been used extensively in the almost 18 years since it was created. The explanation for this is not fully apparent, but may relate to the limited exclusivity, usually three years, allowed for a 505(b)(2) application.
Key WordsWaxman-Hatch 505(b)(2) Pharmaceutical equivalence Bioequivalence Listed drug Patent certification
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- 1.21 U.S.C. 355(b)(2).Google Scholar
- 2.Sasinowski FJ, Scarlett T. Reliance on phantom ANDAs to access NDA data. Reg Affairs. 1991;3:467–482.Google Scholar
- 4.FDA Public Docket No. 99D-4809, Pharmaceutical Research and Manufacturers of America, April 3, 2000.Google Scholar
- 5.Morgan, Lewis & Bockius Citizen Petition, FDA’s Docket Management Branch, July 27, 2001.Google Scholar
- 6.US Food and Drug Administration, Center for Drug and Biologies Evaluation and Research. Guidance: Providing Evidence of Effectiveness for Human Drug and Biologic Products. Rockville, MD: US Food and Drug Administration, Center for Drug and Biologies Evaluation and Research. May 1998. http://www.fda.gov/cder/guidance/1397fnl.pdf.Google Scholar