Last week, former Acting Commissioner and former Commissioner Lester B. Crawford admitted in a deposition that he acted to pre-empt FDA staff from approving the OTC switch of Plan B, according to a report in the Baltimore Sun. What he was thinking by taking such an action is anyone’s guess, but it allows us be grateful that he didn’t do any further damage to the interests of the agency he was heading.
However, Dr. Crawford did not sign the letter to the sponsor when the FDA took their (in)action – it was signed by Dr. Steven Galson. That is a mystery Ed Vawter explores on his QDIS blog and I could not improve on his efforts.
The situation does raise one further question. That is, if Dr. Crawford was the sole reason why the application was suspended, what is stopping anyone from picking up the ball now and undoing that damage.
Not long ago, it was reported that the American College of Obstetricians and Gynecologists were urging women to stockpile Plan B so that it would be available to them when needed. It is truly extraordinary that a professional society would have to take such actions to compensate for the agency’s political mis-steps. It is not good science. It is not good medicine. The FDA is supposed to be about both.
If Dr. Crawford were the sole reason for the hold up, the FDA should simply waste no more time and finally make a move to approve Plan B. It would be great for the nomination of Dr. Andrew C. von Eschenbach. It would be great for the much needed rehabilitation of the agency’s credibility. It would be great for the sponsor. It would be great for the women who need access.
Just do it.
But also, answer the questions about Dr. Galson’s involvement.