Thayer A.M.,C and EN Houston
Chemical and Engineering News | Year: 2014
In September 1984, the Drug Price Competition & Patent Term Restoration Act, commonly known as the Hatch-Waxman Act for its congressional sponsors' names, was signed into U.S. law. By creating a new regulatory path for generic medicines and launching a new business, the act was a watershed in the history of the pharmaceutical industry. Much has changed from that turning point 30 years ago. The complex regulations have been tested, interpreted, and updated. The compliance burden for companies has increased with new rules that help regulators keep pace with a rapidly growing industry and improve their oversight of manufacturing and quality issues. Meanwhile, generics companies have become more aggressive in challenging innovator drug patents. To compete, they are expanding geographically and building portfolios through mergers and acquisitions. And as the pharmaceutical industry on which they rely undergoes its own changes, generics companies are finding new products to imitate, including a.