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DeepModem Mom Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 06:27 PM
Original message
LAT: FDA Nominee's Future Hinges on Morning-after Pill
Edited on Wed Aug-02-06 06:28 PM by DeepModem Mom
FDA Nominee's Future Hinges on Pill
Lawmakers say approval of the agency's interim chief depends on his decision on the Plan B contraceptive's over-the-counter status.
By Ricardo Alonso-Zaldivar, Times Staff Writer
August 2, 2006

....Most Democrats and Republicans agree that the FDA needs a permanent commissioner to confront a host of pressing problems. They also agree that (Andrew) von Eschenbach's confirmation will depend on how he handles a single, symbolic issue: the long-delayed, politically charged decision on the morning-after pill, also known as Plan B.

Religious conservatives oppose allowing its sale without a prescription, which they say could encourage promiscuity and sexual exploitation of young girls. FDA medical reviewers and a panel of outside experts have recommended over-the-counter status regardless of age....

***

The FDA's refusal to reach a final decision on Plan B has led several prominent doctors and academics to question whether the agency has compromised its scientific independence. From 1994 to 2004, the FDA approved 67 medications for sale without a prescription; Plan B was the only one that was denied approval.

"You are caught, unfortunately, in a situation that gives great pause to many of us because of what it means for the future of the FDA," Sen. Hillary Rodham Clinton (D-N.Y.) told von Eschenbach...."Once we start to politicize the FDA, there is no stopping," she continued. "This is a slippery, dangerous slope we are on, Doctor, and we are looking to you to get a decision made."

Clinton and Sen. Patty Murray (D-Wash.) have placed a hold on von Eschenbach's nomination, blocking a floor vote until the FDA makes a decision on Plan B....

http://www.latimes.com/news/nationworld/nation/la-na-pill2aug02,0,1270811.story?coll=la-home-nation
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ismnotwasm Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 07:42 PM
Response to Original message
1. Interesting
"On the day before his hearing, von Eschenbach released a letter to Barr Pharmaceuticals Inc., the maker of Plan B, seeking a compromise and promising a quick decision. But getting an agreement would seem to hinge on the company's ability to convince the FDA that it can keep the drug out of the hands of those younger than 18."


So no one under eighteen needs plan B? And how much success does anybody have keeping anything out the hands of those under 18? It's a ridiculous qualification.

I continue to be truly frightened about what our young women are going to do to for sexual and physical health, up to and including birth control and terminating pregnancies. There is too much rhetoric against birth control, too much misinformation spread about things like sex, Plan B, pregnancy, abortion. Ours is a sexualized nation with confusing and conflicting images.

If a young women is having sex, in my perfect world she would be fully aware of the benefits and consequences, along with her partner, in a mutually respectful relationship, but that doesn't even happen with adults.

Female teenagers aren't even aware of their right or ability for orgasm, much less have a solid understanding of sexual choice. And when a grown woman's right to choose is being attacks on all sides, I don't see the situation getting any better for teenagers.

Since no one has been successful in stopping teenagers from having sex before they are "ready" the next best thing is to have comprehensive education as well encouragement to make decisions for themselves. Since that isn't going to happen either, I would like to see some option. I've seen young women frightened about the possibility of pregnancy. I don't think the experience leads to promicuity, there are other situations that contribute to such things.

Once the ability to become pregnant exists, the possibility exists.


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Lindacooks Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 07:51 PM
Response to Original message
2. Fundies think EVERYTHING 'encourages promiscuity', and
as far as sexual exploitation of young girls, haven't there been quite a few repukes caught with their pants down in that area?
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Miss Chybil Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 09:09 PM
Response to Reply #2
5. It's their sick, perverted minds that put the rest of us in so much
trouble.
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struggle4progress Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 08:13 PM
Response to Original message
3. It's deja vu all over again:
Plan B Delay Raises Questions of Foul Play
Delay in Approving Emergency Contraception Questions Legitimacy of the Scientific Process in Federal Government
Michael Long
April 13, 2004

“The recent decision by the Food and Drug Administration (FDA) to postpone a decision on the proposal to switch levonorgestrel emergency contraception (sold under the brand name Plan B) to over-the-counter status suggests that the FDA's decision-making process is being influenced by political considerations.”
-New England Journal of Medicine, April 8, 2004

With this opening statement, the Editor and Chief of the prestigious New England Journal of Medicine (NEJM) assailed the U.S. Food and Drug Administration’s (FDA) credibility as a fair scientific arbiter of public health. The charge leveled by Dr. Jeffrey M. Drazen and his colleagues is serious and troubling. As individuals, we rely on the FDA to make decisions about the safety and efficacy of medical therapy, not about the ethics and morality of sexual behavior. Use of Plan B within 72 hours of a single act of unprotected sex reduces the rate of pregnancy from 8 percent to 1 percent. This is an 85 percent reduction in pregnancy rates. In December 2003, the FDA’s own scientific advisory committee recommended in a 24-4 vote that Plan B be approved for over-the-counter (OTC) sale ... http://www.healthylivingnyc.com/article/11

Experts not behind reversal on Plan B
FDA bowed to politics, critics say
Marc Kaufman, Washington Post
Friday, June 18, 2004

06-18) 04:00 PDT Washington -- Just days before the Food and Drug Administration rejected an application to make the emergency contraceptive Plan B available without a prescription, top FDA scientists dismissed the reasoning that was used to justify the rejection as unfounded, internal agency documents reveal. The documents, which contain the scientific conclusions of three separate levels of FDA reviewers, show that the scientists disagreed in particular with the contention that there was insufficient information to assess how easier availability of the drug would affect the sexual behavior of young teenagers. That was the primary reason given for the FDA's dismissal of the application as "non-approvable" ... http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/06/18/MNG7V78AGB1.DTL

FDA Nominee to Get Vote; Agency to Act on Plan B Pill
By Marc Kaufman
Washington Post Staff Writer
Saturday, July 16, 2005; Page A04

The nomination of Lester M. Crawford, the administration's embattled choice to head the Food and Drug Administration, got a boost yesterday when three senators agreed to lift their holds and allow a vote on the Senate floor ... Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) announced their decision to lift their holds on the nomination after receiving written assurances that the agency will decide by Sept. 1 whether to allow sale of the emergency contraceptive Plan B without a doctor's prescription ... The assurance of a decision by Sept. 1 came in a letter from Health and Human Services Secretary Mike Leavitt to Sen. Mike Enzi (R-Wyo.), chairman of the committee that voted to endorse Crawford's appointment. "I have spoken to the FDA," Leavitt wrote, "and, based on the feedback I have received, the FDA will act on this application by September 1, 2005" ... http://www.washingtonpost.com/wp-dyn/content/article/2005/07/15/AR2005071501855.html

Plan C
Political Animal by Brian Morton
11/30/2005

... Six months ago, the FDA rejected over-the-counter sales of Plan B, also known as the “morning-after pill.” As a Government Accounting Office report showed, top Bush administration officials jumped into the decision-making process, something the GAO report noted was “very very rare,” and then they ignored both the advice of an independent advisory committee and the FDA’s scientific review staff. The GAO report concluded that a top FDA official created a “novel” rationale for rejecting Plan B’s over-the-counter status, even making the decision before the review process was concluded ... http://www.citypaper.com/columns/story.asp?id=11193
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DeepModem Mom Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Aug-02-06 08:52 PM
Response to Reply #3
4. Thanks for the reminders, struggle4progress! nt
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