| STATUS | Approved by USA Congress in 1984 |
| SUBJECT |
A drug going off patent paves the way for lower priced generic versions. That is always great news for anyone who has to pay the full price of drugs. But because of the law and regulations governing generic drugs, a brand-name drug's loss of patent protection does not guarantee timely access to lower cost generic versions. Marketing of generic products can be delayed through various maneuvers--in which generic companies and innovator drugmakers are either pitted against each other or work hand in hand. At present, marketing of generic drugs is governed by the Drug Price Competition & Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, or simply Hatch-Waxman. Among the loopholes in the current law are the ability of innovator companies to cause automatic multiple delays of Food & Drug Administration approval of generic drugs and the ability of innovator and generic companies to enter into agreements to purposely delay entry of generics. Passed in 1984, Hatch-Waxman gave rise to a robust generic drug industry. By creating the Abbreviated New Drug Application (ANDA), it allowed approval of generic products through a shorter and less costly route than for innovator drugs. It also allowed development of generic versions even when the reference product is still protected by patents. In all other industries, this activity constitutes patent infringement. In the pharmaceutical industry, it allows generic companies to obtain bioequivalency data required for their drug applications. Because of Hatch-Waxman, generic versions hit the market as soon as patent protections on the brand-name product expire, in contrast to the case in many other countries. Before Hatch-Waxman, only 35% of pioneer drugs had generic competition after patents expired; now almost all innovator drugs face such competition, according to the Pharmaceutical Research & Manufacturers of America |
| UPDATE | 09.02 |
| LITERATURE REF. | CEN 23.09.02, p. 53 |
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