ARTICLE | Regulation

Thalidomide 50 Years Later

Regulatory opponents agree patients need to make risk-benefit choices about drugs

September 20, 2010 7:00 AM UTC

Last week FDA honored Frances Kelsey, the agency reviewer who 50 years ago defied industry pressure and refused to allow thalidomide onto the U.S. market for insomnia and morning sickness. The near-miss with a public health disaster shocked Congress into requiring randomized, controlled trials to demonstrate safety and efficacy.

But, as the radio commentator Paul Harvey used to say, there is "the rest of the story."...