Huge announcement today that the FDA will review, once again, Barr Laboratories application to sell Plan B over the counter. Why did this announcement come today, the cynic in me wants to know?
The announcement came just 24 hours before President Bush's nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was scheduled to appear before a Senate committee, where he was expected to face grilling on why the morning-after pill had apparently gone into bureaucratic limbo.
[...]
Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend Tuesday's hearing less on this contentious issue and more on his own plans for the agency if confirmed as its chief.
"He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA," Bro said.
If von Eschenbach new that this is a divisive issue, that the FDA's refusal to clearly and concisely address the issue in a SCIENTIFIC manner, as opposed to the ideology that has surrounded their decisions, then he should have done something MONTHS AGO. How dare he think that women will buy this cowdung-filled excuse! The man has answers to give, on why it took so freakin' long to get to the point he announced today.
This tactic was tried once before, but unlike some others that repeatedly get fooled, Sens Murray and Clinton will continue to withhold their confirmation votes until after a decision on Plan B is made.
Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y, vowed to continue holding up von Eschenbach's confirmation as commissioner until the agency makes a final decision, Murray spokeswoman Alex Glass said. The two had previously allowed von Eschenbach's predecessor, Lester Crawford, to be confirmed after receiving a pledge the FDA would act on the issue. Crawford resigned shortly after delaying a decision.
"Fool us once: We're not lifting this hold until a decision is made," Glass said.
I sincerely hope they will stick to their word, it would be political suicide if they don't. Just saying.
von Eschenbach's office is also noting that they reviewed more than 47,000 comments from the public. check out what they admit the majority of those comments said:
Monday, the FDA reversed itself, saying that it had reviewed about 47,000 comments from the public, with an overwhelming majority supporting the view that the drug could be sold both as a prescription and nonprescription product.
It is important to note that while Barr Laboratories are using the tobacco regs to justify selling OTC to adults and with a prescription to minors, a few adjustments have to be made in their refiling tot he FDA.
_Barr must agree to sell nonprescription to women 18 and older, not 16 as the company had earlier sought. That's because it conforms with current age restrictions on tobacco products, and thus would simplify pharmacists' enforcement.
_Both the nonprescription and prescription versions of the pill would be kept behind the pharmacists' counter. But FDA wants Barr to sell the nonprescription version in completely different packaging to help distinguish the two.
_Barr must provide details on how the program will enforce the age restriction. If that's not rigorous enough, Plan B will remain prescription for everyone, FDA warned.
I also wanted to add this restriction that Barr had already planned on following:
"We already said that we would only sell to pharmacies _ to places where there was a pharmacist, not to convenience stores," Cox said.
Unfortunately, if little Betty Jo is raped by dear Uncle Billy Bob she still won't be able to get some Plan B, unless she goes to a pharmacy, and is over 18. Since many hospitals do not carry Plan B, either, she may still be out of luck if she has the chutzpa to turn Uncle Billy Bob into the police for his unseemly behavior.
The bottom line is, as the FDA continues to futz around with their decision, women's lives are continually at stake. Less and less are women able to get EC with a prescription, let alone at a hospital if they've been raped. Women have been advised to get their Plan B pills before anything could possibly happen, just so that they won't have to deal with hospitals that take the moral high ground and refuse to stock EC, and pharmacists that think they know better than a woman's doctor and refuse to sell EC.
I am really glad that the FDA is going to review Barr laboratories application. and I truly hope that it gets approved this time around. But, don't tell me that von Eschenbach isn't politicizing women's lives in this move today, because he sure as hell is, just like God made little green apples.
Comments