She delays the application long enough that reports start coming in from around the world that maybe, possibly, thalidomide is not what everyone hoped it would be. That's why it was never approved in the US. Uncountable babies spared from severe birth defects and prenatal death. 8/
This inspires the Kefauver–Harris Amendment, which adds "...and efficacy" to the FDA's remit. Yet after all of that she is finally cool to her teenage daughters when she receives the federal government's highest civilian award from their heartthrob, President John F. Kennedy. /fin
I thought that the problem with Thalidomide wasn't the efficacy (it did make morning sickness better) but the lack of safety (it caused birth defects)? Or are those terms different in a clinical context aside from their common usage?
you are 100% correct, and the problem with the safety data submitted in their FDA application was that it was lies