ABSTRACT
This chapter provides an overview of the required regulations the biopharmaceutical industry follows to develop and launch new drugs in the US market. Accumulated public awareness and Congress' acknowledgment of deceptive safety and efficacy claims from marketed drugs and manufacturers led Congress to pass the Drug Act Amendments of 1962. The Act of 1962 required manufacturers to produce evidence of safety and efficacy to receive Food and Drug Administration FDA approval for marketing. Subsequently, Congress enacted the Drug Price Competition and Patent Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act of 1984 facilitated earlier market entry of generic drugs while honoring patent rights of biopharmaceutical companies. In addition, it is important to mention the Orphan Drug Act of 1983 and its implication on the biopharmaceutical industry. The Orphan Drug Act provided various financial incentives such as grants and market exclusivity for biopharmaceutical companies to bring drugs for rare disease markets.
