Tuesday, May 11, 2010

The other revolution started by "The Pill"

This article is a week old, but I still wanted to point it out. Last week was the 50th anniversary of FDA approval of the birth control pill. Approval of the birth control pill is credited being one of the events that led to the "sexual revolution." But as this article points out, the approval of the pill started another revolution, a revolution at the FDA. At the time of the pill's approval, the FDA started to take a strong role in post-market surveillance, that is, continued observation and research of drugs after they have been approved. With the pill, we also saw the beginning of the FDA's direct communication with patients, rather than communication from the FDA to patients via physicians. The approval of the pill also followed the expansion of the process of clinical trials to show safety and efficacy of a drug, procedures that are now commonplace. It's an interesting piece of research history and shows how we came to the regulations researchers now face today.

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