By Paul Howard | The Wall Street Journal
In the late 1950s and early 1960s, thalidomide was used as an anti-nausea drug by tens of thousands of pregnant women in Europe and Japan, some of whose children developed severe birth defects. Although thalidomide was never approved by the FDA, millions of free tablets were given to doctors as part of company-sponsored clinical trials, and 40 American children were born gravely affected. Not surprisingly, this led to a backlash against the drug industry. In 1962, Congress passed the Kefauver-Harris Amendment, giving the FDA power to require drug makers to demonstrate not just that drugs were safe for human use, but that they effectively treat the symptoms they say they do.
