ABSTRACT
According to Saul (2007), the United States spends about $275 billion annually on prescription drug products. In addition, Saul (2007) also pointed out that, in the next 5 years, a series of innovative drug products with a total combined annual sale of $60 billion are going off patents. This opens the door for a tidal wave of generic drug products that are 30%–80% cheaper than the innovative drug products. In 1984, the United States 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 (Frank, 2007). As a result, when an innovative (brand-name) drug product is going off a patent, pharmaceutical or generic companies can Œle an abbreviated new drug application (ANDA) for generic approval. For the approval of a generic drug product, most regulatory agencies require that evidence of average bioavailability (in terms of drug absorption) be provided through the conduct of bioequivalence (BE) studies. However, as pointed out by Saul (2007), a survey conducted in 2002 by the Association of American Retire People (AARP) indicated that 22% 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 the United States still lacks conŒdence in generic drug products even if they are approved by the United States Food and Drug Administration (FDA). Therefore, in May 2007, the FDA added generic drugs in the Critical Path Opportunities to use latest breakthroughs in technique to assure that the efŒcacy and safety of the generic drug products are the 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.
