What the FDA s Decision on Thalidomide Really Means
LOST IN ALL OF THE HULLABALOO surrounding the FDA s reversal last week of its 1962 ban on Thalidomide, the drug that was linked to horrific birth defects, was perhaps an even greater story: what essentially amounts to the very refocussing of the FDA s raison d etre.
When the FDA reversed itself and approved Thalidomide, there was no suggestion that the teratogenic results of Thalidomide would no longer occur. Rather, the move signals a changing of the paradigm that guides the agency.
Executive Summary