Bad Medicine: The Prescription Drug Industry in the Third World

By Milton Silverman; Mia Lydecker et al. | Go to book overview

CHAPTER 4
THE GREAT GENERICS CONTROVERSY

For many decades drug companies in the United States had been accustomed to operate under a federal law that presumably offered them patent protection or exclusivity for a period of seventeen years. After that time competitors could apply for the right to make and market the same drug. The original drug was generally known as the original brand-name or innovative product. The later versions were generic competitors. They were supposedly less expensive.

That, however, was not the whole story. In the past a company discovering a new drug would apply immediately for a patent, which usually was issued in a reasonably short time. Thereafter, as soon as the drug had been approved by the Food and Drug Administration--a process that might take a few months or a year or so--the company would be permitted to market its new product. Of the seventeen years of legal patent life, the firm still had fifteen or sixteen years remaining in which to recoup its investment. But in 1962 the law was changed to require lengthy and costly efficacy studies. In addition, the companies complained, the FDA approval process began to take an unreasonable and increasingly longer time. As new drugs became more and more complex, as more sophisticated and more time-consuming tests were introduced, as mounting pressure was exerted on FDA to keep all dangerous drugs off the market, as FDA demanded more time-

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