Too fast, too soon?
The US FDA is widely considered to be the best food and drug regulatory agency in the world. However, the withdrawal of Zelnorm begs the questions: Is the FDA moving too fast?
Also, Zelnorm was originally targeted to women. It is well known in the industry that the usual subjects of clinical trials tend to be young men. This new debacle also begs the question: Are women being short changed in clinical trials? Are we exposing them to risks without adequate testing?