the lesson of thalidomide is that the FDA back then might have been slower than the review agencies in europe or the mfg filed for approval later in the U.S., and mfg didn't test the drug in pregnant animals. if it had been a U.S. mfg, the U.S. might have had the thalidomide babies and not the rest of the world. that was a case of gross negligence.
http://blogs.fda.gov/fdavoice/index....ation-matters/