ABSTRACT
In 1984, the US Congress passed the Drug Price Competition and Patent Term Restoration Act, which allows a regulatory framework for a low-cost pathway for generic drug products to enter the market. This Act gives the FDA the authority to approve a generic drug product via an Abbreviated New Drug Application (ANDA). As a result, when an innovative (brand name) drug product is going off patent, pharmaceutical or generic companies can file an ANDA for generic approval. For approval of a generic drug product, most regulatory agencies require evidence of average bioavailability (in terms of extent and rate of drug absorption) be provided through the conduct of bioequivalence studies. As indicated by a survey conducted by the Association of American Retired People (AARP) in 2002, about 22 percent of the responders considered that generic drug products are less effective or of poor quality than the innovator drug products. This shows that a sizable portion of the public in United States still lacks of confidence in generic drug products even if they are approved by the FDA. Therefore, in May 2007, the FDA added generic drugs in the critical path opportunities to use the latest breakthroughs in technique to assure that the efficacy and safety of the generic drug products are same as those of the innovator drug products. However, the FDA critical path opportunities for generic drugs do not cover all important emerging challenges for generic drugs.
