Food and Drug Amendment Act. "Drug Lag".

     From the time it was first proposed, the 1962 Amendment to Food and Drug and cosmetic Act   have been the subject of controversy among some elements of the health community and the pharmaceutical  industry. The Amendments added a new requirement for food and drug Administration approval of any new drug. The drug must be demonstrated to be effective by substantial evidence consisting  adequate and well controlled investigations. To meet this effectiveness requirement, a pharmaceutical company must spend considerable time and effort in clinical research before it market a new product in the USA. Only then can it begin to recoup its investment. Critics of the requirement argue that the add expense of the research to establish effectiveness is reflected in higher drug cost, decrease profits, or both, and that this has resulted to "drug lag".

    The term drug lag has been used in several different ways. It has been argued that the research required to prove effectiveness creates a lag between the time when a drug could be theoretically be marketed within proven effectiveness and time when it is actually marketed. Drug lag has been used to refer to the difference between the number new drugs introduced annually before 1962 and the number of drugs introduced each year after the date. It is also argued that the Amendments resulted in a lag between that time when new drugs are available in the United States. And drug lag has also been used to refer to a difference in the number of new drugs introduced in the per year in other advanced nations and the number introduced in the same year in the United States.
     Some Critics have used drug lag arguments in an attempt to prove that 1962 Amendments have actually reduced the quality of health care in the United States, and  that, on balance; they have done more harm than good. these critics recommend that the effectiveness requirements be drastically modified or even scraped. Most of the specific claims of the drug lag theoreticians, however, have been refuted . The drop in new drugs approved annually, for example, began at least as early as 1959, perhaps five years before the new law was fully effective.