FDA rejected Plan B in "very, very rare" move

Have you hugged the Government Accountability Office today?

The non-partisan GAO published a report yesterday saying that FDA officials rejected Plan B's application to be sold over-the-counter months before the scientific review was completed.

In December 2003, an FDA advisory committee ruled 23-4 to make Plan B available over the counter.

Within days of the committee's vote, however, Dr. Janet Woodcock, the F.D.A.'s acting deputy commissioner of operations, and Dr. Steven Galson, acting director of its drug center, told four top staff members that the application would be rejected, even though the agency's scientific review of the application had yet to be completed, the staff members told Congressional investigators. That review was completed in April. [NYT permalink (link fixed)]

This was just one of the many unusual things the GAO noticed about the FDA's handling of Plan B's OTC application:

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.

Here's another odd thing. Nobody knows what part Scott McClellan's brother played in all this while he was FDA commissioner:

"[...] Congressional investigators had been unable to uncover the role in the Plan B decision played by the former agency commissioner, Dr. Mark B. McClellan, because agency officials told investigators that all of his e-mail messages and written correspondence on the subject had been deleted or thrown out. The Democrats charged that these acts contravened federal records laws."

The FDA's official rationale for rejecting the OTC switch was that the drug hadn't been tested on enough young adolescents. Only about five percent of the subjects were between the ages of 14 and 16, and none of the participants was under 14. However, FDA reviewers routinely extrapolate data from older adolescents to predict the behavior of their younger counterparts in other reviews.

Clearly, we need another FDA. That way, there will always be an FDA on duty when the first FDA's religion prevents it from doing its job.

Comments

[aflounder]

This is the new and improved FDA, the Federal Denomination Authority, misinterpreting principals of Christianity for the benefit of the Christian Fundamentalist Misogyny, sorry, the Christian Fundamentalist Majority.

[rob helpy-chalk]

Have you hugged the General Accounting Office today?

This actually sounds like it would be fun. I imagine going to an office where a lot of tired accountants and bureaucrats sit in cubicals and starting to hug people. Maybe I could give out chocolate, too.

[Jonathan Ichikawa]

This is really upsetting -- thanks for bringing it to our attention.

Your NYT link is broken, by the way.

[Lindsay Beyerstein]

Thanks, I'll fix that.

Also, I just remembered that GAO is the General Accountability Office now. So, if anyone claims to be from the General Accounting Office, don't hug them, it's got to be some kind of scam.

[almostinfamous]

So, if anyone claims to be from the General Accounting Office, don't hug them, it's got to be some kind of scam.

you can still hug them, just keep an eye on your wallet and kidneys

[Grumpy]

One other thing to fix: Mark McClellan is Scott McClellan's older brother, not brother-in-law. The hint is that their names are the same.

Say, this "making decisions before the facts come in" sure is more efficient than the other way. We should use it for other matters, like foreign policy!

[Eric Wallace]

Sorry to nitpick, but it's now called the Government Accountability Office, formerly the General Accounting Office. In any case, hugs are in order.

[Bob Koepp]

Facts? We don't need no stink'n facts. We've got an agenda.

[Lindsay Beyerstein]

See, Bob? I eventually got around to hatin' on the FDA for their Plan B bullshit. heh.

A couple weeks ago Bob asked why so many bloggers were denouncing Target and pharmacists of "conscience" who wouldn't fill ECP prescriptions without denouncing the FDA for refusing to make Plan B available over the counter. For me, the reason was that I had no idea the evidence ideologically-motivated malpractice was so overwhelming.

[Bob Koepp]

My "ideologically-motivated malpractice detector" is activated when the FDA deviates from the principle that substances which can be safely self-administered should be available OTC. My detector seems never to be off!