FDA put politics over science?

[zakur]

GAO: FDA Ruling on Morning After Pill was Unusual

The Government Accountability Office report said the apparent involvement of McClellan and other top officials was one of four unusual aspects of FDA's handling of the politically sensitive decision. The investigators reported that several key FDA officials told colleagues that the application to allow over-the-counter sales of the emergency contraceptive would be rejected months before the decision was announced.

The proposal for nonprescription sales of the ''Plan B" contraceptive was actively supported by FDA staff and by a joint advisory panel of experts, and the decision caused considerable internal dissent.

[...]

Many proponents of easier access to Plan B charge that political considerations had intruded into the FDA decision-making, which is by law supposed to be based solely on scientific evidence.

The key findings of the GAO report were that the FDA did not employ its usual procedures and scientific standards in weighing the Plan B application. GAO investigator Marcia Crosse said it was unusual for top FDA officials to get actively involved. The decision to reject the application was signed by Steven Galson, the senior officer of the Center for Drug Evaluation and Research, because lower-ranking officials disagreed with his conclusion.

The GAO investigation uncovered evidence of a coverup, as well:

...the GAO was unable to fully understand McClellan's role because he would not speak with the investigators and because the agency provided no documents reflecting his communications with other officials. The FDA told the investigators that e-mails to and from McClellan had been deleted and that written memos were routinely destroyed.

Raising the possibility that the practice was a violation of federal record-keeping law, the lawmakers wrote: ''This potential violation of records management laws and regulations is not a mere technicality. On the contrary, as the Plan B decision makes clear, retaining the documents of the agency head is essential for the transparent operation of government."

 

[Ed]

Well Duh.

Are you surprised?

 

[zenith-nadir]

Everyone knows sex is a "gift of God" to be experienced only within marriage and premarital sex is a sin. How dare those satan-worshiping chemists and biologists create an emergency contraceptive.

Burn'em!

 

[Mark]

Well Duh.

Are you surprised?

Nope. On the other hand, the length Republicans will go ("Bush never linked Iraq and 9/11!") to attempt to excuse this administration's malfeasance and corruption is almost getting amusing. I can't wait to hear how they spin this.

 

[Ed]

Nope. On the other hand, the length Republicans will go ("Bush never linked Iraq and 9/11!") to attempt to excuse this administration's malfeasance and corruption is almost getting amusing. I can't wait to hear how they spin this.

It is not spinnable. The provisional head of the FDA had promised a "quick" decision on Plan-B in order to get confirmed.

 

[Mark]

It is not spinnable. The provisional head of the FDA had promised a "quick" decision on Plan-B in order to get confirmed.

Yeah, but I never would have imagined anyone would even try to claim Bush never linked Iraq and 9/11; I am still reeling over that one. So while I agree there is no way to spin this, I have to believe the attempt will be made.

I'd love to be wrong, though.

 

[Ed]

True. Since the goat fornicators dispise the american electorate, they can say any damn thing and just keep insisting. Bill "The Channeling Diagnostition" Friske anyone?

 

[Luke T.]

Bush never linked Iraq and the morning after pill.

 

[Ed]

Bush never linked Iraq and the morning after pill.

How true. He screwed us and now we have to take the consequences.

 

[Freakshow]

Shocked! Shocked, I am, that any government agency would put politics over science!!!

SOMEONE hasn't been paying attention, have they?

 

[Nyarlathotep]

I heard about this on the news this morning. The FDA officials involved apparently quite adamantly deny that it was a political decision. My question is, why do they bother? The report points to them making the decision months before the science was in. No one is even shocked that they made the decision based on politics rather than science. They could at least salvage their dignity by being honest about it. But no, they have to play the game, I suppose.

 

[Mark]

I heard about this on the news this morning. The FDA officials involved apparently quite adamantly deny that it was a political decision. My question is, why do they bother? The report points to them making the decision months before the science was in. No one is even shocked that they made the decision based on politics rather than science. They could at least salvage their dignity by being honest about it. But no, they have to play the game, I suppose.

They bother because the party loyalists will buy it.