Hillary got punk'd.
In June, Clinton and Murray placed a hold on the nomination of Les Crawford to FDA commish, letting up only on the condition that the FDA say yes or no by Sep. 1 on making the "morning after pill" available over the counter to women over the age of 16. Crawford went through.
Well, just before the end of the Friday workday, the agency held a hastily-assembled press conference to announce that even though they had decided Plan B was safe for women over the age of 17 to buy over the counter, they were postponing a decision until it could hold a "public comment period (i.e., invite Mullah Dobson out to Rockville to tell `em all how this pill is a pre-scription for for-ni-ca-tion)." Quoth the Crawford:
There's more...
The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues.
In some cases, the questions we were asked to answer were unprecedented for this agency.
In particular:
Can age be used as a criterion on which we decide whether a drug should be prescription or over-the-counter, as has been proposed in this case?
Can the prescription and over-the-counter version of the same drug be marketed in a single package?
In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a prescription product, or an over-the-counter product, how, as a practical matter, would such a limitation be enforced?
These are profound regulatory decisions that cut to the heart of our work. The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs.
See, it's a simple question of age as a criterion -- not gender or a woman's right to control her own ovaries. Nope. Nothing to do with S-E-X and the fairer -- well, you know. Oh, and the FDA? The agency that brought you Vioxx? All about transparency:
We believe these novel regulatory issues should be considered in an open, public process.
Rather than answering these questions in the context of a decision on a single drug, we need to have an open process to solicit public comment.
These regulatory and policy questions are too profound and cut across too many different products to be made behind closed doors.
After 12 years of this shit, you'd think some Dems would learn: there's nothing to be gained from playing nice with these bastards. Nothing. And you better see the goods up front before you sign on any dotted lines. Suckers.
Update: Clinton and Murray released a statement saying:
A delay is not a decision. For six months we have asked for a simple answer -- yes or no. It is a breach of faith to have this administration give us their word that a decision would be made, and have that promise violated. FDA's only criteria for approval should be safety and efficacy, not politics and ideology.
All aboard the cluetrain. Senators, where you been? NARAL's also huffing and puffing:
The Bush Administration has broken its promise to the U.S. Senate and the American people to make this decision, after more than two years of stalling.
Shock! Horror! Maybe Linc Chaffee can save the day?