Overview of the Hatch-Waxman Act and its impact on the drug development process.

There is a paucity of legislative history on the Hatch-Waxman Act. This article will try to provide a general overview of the legislative process and some insight into the Act’s underlying assumptions, with the help of some graphics. With a bill as hardfought as Hatch-Waxman, there was much written about it after the fact, but not a great deal of coherent legislative history. The article also provides a timetable to compare the drug discovery and development, patent protection, and generic competition processes that the Act affects. Prior to 1962, drugs were approved for safety only. Senator Estes Kefauver (DTN) tried for years to add an efficacy requirement, a concept that the research-based industry fully supported, but as often happens in Washington, there was a logical disconnect. The Thalidomide problem in infants — involving safety — resulted in the 1962 drug amendments to the Federal Food, Drug, and Cosmetic Act, which added a proof-of-efficacy requirement to new drug approval. Thus, new drugs must be proven safe and effective prior to the Food and Drug Administration’s (FDA’s) approval. Also, for drugs approved prior to 1962, generic versions could be approved with a “paper” new drug application (NDA). The paper NDA was based solely on published scientific or medical literature; a generic manufacturer could get its drug approved by showing that learned articles had been written about the chemical demonstrating that it was safe. After 1962, there was congressional testimony that there were 150 drugs that were off-patent, but for which there were no generics because generic companies simply would not spend the time and money doing the clinical trials to get to market, and that there were only fifteen “paper NDAs,” for post-1962 generics. For those who ask whether Hatch-Waxman was a good deal or a bad deal for the research-based pharmaceutical industry, the most learned response is: It was not a good deal, unless one believed that FDA was going to go forward with its plans to implement abbreviated new drug applications (ANDAs) through regulation. If one thought that was going to happen — and FDA was working on it — then HatchWaxman probably was a good balance. If one did not think that would ever happen, Hatch-Waxman probably was not a good balance, at least at the time.