August 24, 2006
The Politics of Plan B
Let me see if I have this right.
President Bush at his Tuesday press conference says he will allow adults to purchase morning-after contraception pills over-the-counter.
On Wednesday, acting Food and Drug Administration director Andrew von Eschenbach releases a memo to staff (leaked to the Washington Post) outlining the agency's reasoning for limiting access to those over 18.
The FDA then announces today that its three-year review of Barr Pharmaceuticals' application is finally over and approves limited over-the-counter access (no gas stations or convenient stores, no one under 18) to Plan B. In an unusual move, the top official of the Center for Drug Evaluation and Research, Steven Galson, signs the order.
Do they expect us to believe this decision was based on science, after going to the White House to ask permission to make this decision? Do they do that for other drug applications, or just the ones that offend the religious right?
The American Taliban may be fulminating because the FDA allowed this form of birth control. But that's not the real story here. The long saga behind Plan B shows how FDA's independence and reputation as a science-based agency has been thoroughly undermined by this administration. That's not just bad news for sexually active teenagers. That's bad news for every American.
Posted by gooznews at August 24, 2006 06:42 PMHow is killing an "hours-old" embryo with a "morning-after" pill any less murderous than killing a soon-to-be-discarded embryo by means of stem-cell harvesting? Isn't the moral dilemma identical? And if so, how can one (the morning-after pill) be "approved" while the other (embryonic stem-cell harvesting) is forbidden? Circumventing research that might actually CURE diseases by citing moral and ethical concerns is disingenuous at best. To then permit a "morning after" pill to enter the marketplace shows only that pharmaceutical industry profitability is the driving force behind (almost) all FDA edicts. And we are to believe that this agency is looking out for us?!
NOT!
Posted by: Melody at August 24, 2006 08:41 PMYes, you are right, the entire thing has compromised the integrity of the FDA. However, given that the White House could have gone the disastrous route of maintaining their ideological position on Plan B and simply instituted a recess appointment for von Eschenbach, I have to say that I breathed a sigh of relief and hope that this can be the beginning of some healing for the agency.
Posted by: Mark Senak at August 27, 2006 03:05 PM
Of course the decision wasn't based on science. Butdo you really mean Plan B compromised the integrity? I think it compromised maybe public confidence, but the integrity was gone before that.
The administration was taking hits for the dishonesty surrounding Plan B and the lack of competent leadership in the agency. Von E. (or someone else) saw an opportunity to solve a problem...get Plan B on the market, but still go against the science and deny it to those under 18. Essentially, a "third way."
A recess appointment was an option, but one would think that would simply leave an open wound and the administration would continue to be thrashed.
Unfortunately, the healing will probably not begin until 2007, when the underqualified and flat-out unqualified who are in senior leadership positions will likely begin to leave. Hopefully, at that point, FDA will go back into the hands of the scientists. Then again, we will have to see what the agency budget is for FY 07 and 08...see if anything is left for the scientists.
Posted by: scotty at August 28, 2006 12:39 AMDont worry about the 18 age limit.
All US teenage girls have either fake ID or a big sister/friend.
Pip pip!
Posted by: Insider at August 29, 2006 05:35 AM