1115.org

We’ve written before about the FDA’s decision to keep the Plan B “morning after” contraceptive from attaining over-the-counter status, which ignored the recommendations of the agency’s own experts and advisory panels. Considering that such an action is, at best, unusual, it didn’t take a degree in Tinfoil Hat 101 to conclude that the agency’s decision-makers were bowing to pressures from those who opposed Plan B for religious or “moral” issues. You mean that someone in modern politics bypassed science to make the abstinence-only crowd feel self-important? Shocking!

So what has changed since we last wrote about this? The Government Accountability Office, which had launched an investigation into the matter, has finally released their report. And what they concluded should raise serious warning signs about the way our current government is dealing with “controversial” medicines—in the case of Plan B, the decision to reject it was made arbitrarily by top officials before the experts even finished their review.

Senior Food and Drug Administration officials were told that the application to sell the “morning-after pill” without prescription was going to be rejected before the staff completed its scientific review and months before the decision was made public, government investigators reported yesterday.
[…]
The report said, for instance, that the leaders of some FDA science divisions and offices recalled that top officials, including Steven Galson and Deputy Commissioner for Operations Janet Woodcock, told them months before the rejection that the application would not be approved. Woodcock and Galson, then acting director of the Center for Drug Evaluation and Research, recalled that they only discussed the possibility of a rejection and what might be missing from the application. It was Galson who signed the Plan B rejection in May 2004 after the lower-ranking officials who would normally have signed off refused.

So why did the FDA brass decide to kill the Plan B approval, despite the fact that it went against their own experts’ opinions and was put in place before the review process was completed? Former commissioner Lester Crawford initially refused to talk with GAO investigators, and subsequently only offered up a lawyer-provided statement of “I had nothing to do with it.” Another former commissioner during the time in question, Mark McClellan, also refused to speak to investigators and didn’t respond to written questions about his role in the decision. Furthermore, the FDA provided no documents about McLellan’s communications and told investigators that all of his e-mails and memos had been destroyed. Your transparent government at work.

It seems like Mark has been taking some lessons from younger brother Scott on how to dodge a question. But once you look past the staggering arrogance of public officials refusing to cooperate with investigations or reveal their decision-making processes, it becomes apparent that the Plan B approval was killed for some reason. And since it wasn’t on the basis of science or data, the only logical conclusion is that it was held back to satisfy social conservatives that see every form of birth control as an abomination, who question not the safety of the drug but the intent behind it.

But even though the faces change, the game stays the same. Despite the GAO report, the scientific evidence and the chorus of criticism about the FDA’s handling of the Plan B matter, the agency has still found ways to stonewall the drug’s implementation. The newest stalling tactic is to delay approval of the drug until after the agency reviews reviews thousands of public comments, an action that could conceivably stretch on for months or years and has nothing to do with the underlying questions of safety and effectiveness. Same as it ever was.