In a crucial decision taken to delay action on Barr Pharmaceuticals Inc.'s 'morning-after' contraceptive the FDA chief did not take two senior officials opinion.
The FDA is in thick smoke as it has been sued by the non-profit Center for Reproductive Rights saying science was influenced by politics.
Director of the FDA's Center for Drug Evaluation and Research, Dr. Steven Galson, admitted that he wanted to approve the drug. Still, in Galson's words, "then Acting FDA Commissioner Lester Crawford told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application."
A set of pills that can prevent pregnancy if taken within 72 hours of sexual intercourse is what the drug is all about.
The acting chief then, Crawford was confirmed as permanent FDA commissioner in July 2005. Thereafter this delay was announced.
This is the bone of contention and can land him in trouble.