Log in

No account? Create an account

Previous Entry | Next Entry


One of the least surprising court decisions I've heard about in awhile, yet it remains deeply satisfying. Reports the Wall Street Journal Health Blog:
A federal court ruling that overturned some age limits on over-the-counter sales of the morning-after contraceptive Plan B slammed several current and former officials with the FDA, including the current acting Surgeon General. The WSJ reports on ruling this morning.

Dr. Steven Galson, who was named acting Surgeon General in 2007 and is also acting assistant secretary for Health and Human Services, was criticized by Judge Edward Korman of the Eastern District of New York. In a 52-page decision handed down yesterday, the judge said Galson bowed to the Bush administration and its “constituents.”

“The pressure coming from the White House appears to have been transmitted down by the Commissioner’s office in such a way as to significantly affect Dr. Galson’s position on the over-the-counter switch application,” wrote Korman, who went on to detail the contacts between the White House and FDA leaders.

The judge cited a deposition by Galson’s then–deputy John Jenkins, who now runs the FDA’s drug-approval office, that portrayed Galson as worried about keeping his job as acting chief of the Center for Drug Evaluation and Research at the time.

Jenkins testified that “there were occasions where … Dr. Galson … told me that he felt that he didn’t have a choice, and … that he wasn’t sure that he would be allowed to remain as Center Director if he didn’t agree with” a 2004 decision to delay approval of the pills, which were made Barr Pharmaceuticals, now a unit of Teva.

After Galson finally did decide to draft a letter to Barr allowing over-the-counter sales for those 17 and older — the White House and conservatives didn’t want OTC sales approved for any age — Galson’s authority to approve the limited sales was taken away by the then-FDA Commissioner Lester Crawford. The FDA’s 2006 approval of Plan B’s sales without a prescription soon led to a doubling of its sales.

The judge also said the only two times the FDA moved forward on Plan B were when Senate Democrats held up FDA commissioner confirmation votes, such as the one for Andy von Eschenbach in 2006, which was held being hostage at the time by Hillary Clinton of New York and Patty Murray of Washington. And the judge basically agreed with some agency employees’ testimony that FDA officials had stacked an advisory committee to debate the safety of Plan B for over-the-counter sales with people from the “Right to Life antiabortion world.” The panel voted 23-4 in favor of the drug, anyway.

Korman’s ruling cold provide fodder for the Obama White House, which has been on a campaign about the importance of scientific integrity. The decision could also be taken to aid FDA whistleblowers and critics, including the omnipresent Sen. Chuck Grassley, who have complained of cases where they say the FDA trashes science for politics and that advisory committees named by the agency are sometimes stacked.

The administration didn’t make Galson available for comment. Korman, by the way, is a Reagan appointee.
Motherfuckers. I, and everyone else paying attention, at the time, knew that those motherfuckers were making decisions that were politically motivated rather than scientifically sound. And way to go, Judiciary, for bitchslapping people who deserve it.


( 1 comment — Say something )
Mar. 24th, 2009 09:37 pm (UTC)
It's so weird to live in a time where science means something.

*shakes head*
( 1 comment — Say something )