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FDA Decision a Victory for Adult Women, Leaves Young Women Vulnerable

by NOW
FDA Decision is a Victory for Millions of Adult Women,
But Leaves Young Women Vulnerable

For Immediate Release
Contact: Mai Shiozaki, 202-628-8669, ext. 116; cell 202-641-1906

Statement of NOW President Kim Gandy

The Food and Drug Administration's (FDA) decision today to allow Plan B, the emergency contraceptive (EC) manufactured by Barr Pharmaceuticals, to be sold without prescription (over-the-counter) to women age 18 and older is a step in the right direction for women's rights and reproductive health, but it is an incomplete victory.

For several years, NOW leaders and community activists have pressured the FDA to approve easier access to emergency contraception. We have submitted formal comments as part of the FDA review process, testified before FDA advisory panels, generated thousands of emails and phone calls to the FDA commissioner, rallied activists in front of the FDA and Department of Health and Human Services headquarters, and circulated petitions to Congress, and today our efforts have secured an advance for women.

But this important advance is limited by the Bush administration's determination to favor politics over science, in that the FDA has again disregarded the near-unanimous recommendation of its own professional staff and two expert Advisory Committees. Both groups advised that EC meets all of the tests for an off-the-shelf (non-prescription) medication and should be available to all women in that manner. The FDA also disregarded studies establishing that easy access to EC did not increase sexual activity in young women, and did not decrease the use of other forms of contraception.

The availability of EC without a prescription at local drugstores could increase the ability of millions of adult women to prevent unplanned pregnancies. But it is disgraceful and unethical that the FDA has denied over-the-counter access to this crucial emergency contraceptive to another group of women who have the greatest need to prevent unplanned pregnancies—young women.

But the placement "behind the counter" still means that even an adult woman may have to contend with a moralizing lecture from the cashier or pharmacy clerk, and deal with the same kinds of refusals that now face women trying to fill a prescription. And those problems can delay access to EC, which is most effective when taken within 24 hours.

Emergency. Contraception. What part of EC don't they understand? EC should be available to all women, without interference or barriers imposed by a church or the state.

A young woman needs ready access to emergency contraception for the same reasons that an older woman does. Because she fears that unprotected or forced sexual intercourse may lead to an unplanned, unwanted pregnancy. Because she may not be able to see her doctor to obtain a prescription during the 72-hour window when emergency contraception is most effective. Because she may not have health insurance and can not afford an appointment with a doctor. Further, even if a young woman has a prescription, her pharmacist might refuse to fill it.

To those who argue that we cannot trust a young woman to follow the instructions for EC (one pill now, and another one in 12 hours—it's not rocket science), I ask them, "Then why will you trust her to bear and raise a child"?

A simple two-dose pack, EC is easy to use and it's safe. It contains the same medication found in birth control pills, which have been used by millions of women for decades. It has no adverse health consequences that would justify the extreme measures that the FDA is requiring in order to deny access to young women. Finally, the argument that easier access to EC would encourage promiscuity is not only insulting to young women, but there is specific evidence in the form of studies to refute that claim. Instead of sound scientific reasoning, political ideology has been the basis for this decision, as it has been throughout the approval process.

People across the political spectrum should be able to agree that we need to reduce the number of unintended teen pregnancies—there were approximately 235,000 in 2001 alone—and the availability of EC to all women for purchase over-the-counter is an effective way to prevent those pregnancies. NOW will continue to demand access to EC until it is approved for over-the-counter use by all women, available on store shelves (not behind the counter), and dispensed without interference.
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by Feminist Majority
Feminist Daily News Wire - 8/24/2006
BREAKING NEWS: FDA Approves Over-the-Counter Status for EC

The Food and Drug Administration (FDA) announced its approval of over-the-counter status for Plan B emergency contraception for women 18 years and older at a press conference today. The announcement is a major victory for women and women’s health advocates nationwide, who have demanded FDA approval for over-the-counter access since 2003. Emergency contraception (EC) is effective up to five days (120 hours) after unprotected sex, birth control failure, or rape, but it is most effective (95 percent) if taken within 24 hours. Because of the time-sensitive nature of EC, over-the-counter access is crucial to its effective use.

The approval of EC over-the-counter is a result of the demands of women across the country, especially of young women. The Feminist Majority Foundation has sent tens of thousands of petitions to the FDA asking for approval of EC over-the-counter, and conducts a major campaign to increase access to EC on college campuses around the nation. Women’s health advocates also credit Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) for their work blocking the confirmation of FDA commissioner nominees Lester Crawford and Andrew von Eschenback until the FDA made a decision on over-the-counter status for Plan B.

“This decision is long overdue. For nearly three years politics took precedence over good science and good health policy decisions and women's health suffered,” said Dr. Susan Wood, who resigned from the FDA in protest of the agency’s delay in approved over-the-counter status for EC. “While I am glad that the drumbeat for a return to a science-based FDA has had some positive impact, this decision still represents a compromise – one that could have the unintended consequence of hurting young women's health.”

FeministMajority.org - Your source for the feminist perspective on political
Media Resources - PRNewswire 8/24/06; Washington Post 8/24/06; FDA Press Release 8/24/06; Reproductive Health Technologies Project Press Release 8/24/06; Statement of Susan Wood 8/24/06
by Questioner
>The Food and Drug Administration's (FDA) decision today to allow Plan B, the emergency contraceptive (EC) manufactured by Barr Pharmaceuticals, to be sold without prescription (over-the-counter) to women age 18 and older is a step in the right direction for women's rights and reproductive health, but it is an incomplete victory.<

Well, you can't win them all...

>For several years, NOW leaders and community activists have pressured the FDA to approve easier access to emergency contraception. We have submitted formal comments as part of the FDA review process, testified before FDA advisory panels, generated thousands of emails and phone calls to the FDA commissioner, rallied activists in front of the FDA and Department of Health and Human Services headquarters, and circulated petitions to Congress, and today our efforts have secured an advance for women.<

Yes, I'm sure there is no way this would have ever happend without you.

>But this important advance is limited by the Bush administration's determination to favor politics over science, in that the FDA has again disregarded the near-unanimous recommendation of its own professional staff and two expert Advisory Committees. Both groups advised that EC meets all of the tests for an off-the-shelf (non-prescription) medication and should be available to all women in that manner. The FDA also disregarded studies establishing that easy access to EC did not increase sexual activity in young women, and did not decrease the use of other forms of contraception. <

What studies are these?

>The availability of EC without a prescription at local drugstores could increase the ability of millions of adult women to prevent unplanned pregnancies. But it is disgraceful and unethical that the FDA has denied over-the-counter access to this crucial emergency contraceptive to another group of women who have the greatest need to prevent unplanned pregnancies—young women. <

Is it ethical to allow a young girl to go behind her parents back?

>But the placement "behind the counter" still means that even an adult woman may have to contend with a moralizing lecture from the cashier or pharmacy clerk, and deal with the same kinds of refusals that now face women trying to fill a prescription. And those problems can delay access to EC, which is most effective when taken within 24 hours. <

Are you nuts??? Do you really think a $7 an hour clerk gives a shit what your buying??

>Emergency. Contraception. What part of EC don't they understand? EC should be available to all women, without interference or barriers imposed by a church or the state. <

I'm not seeing alot of barriers here...

>A young woman needs ready access to emergency contraception for the same reasons that an older woman does. Because she fears that unprotected or forced sexual intercourse may lead to an unplanned, unwanted pregnancy. Because she may not be able to see her doctor to obtain a prescription during the 72-hour window when emergency contraception is most effective. Because she may not have health insurance and can not afford an appointment with a doctor. Further, even if a young woman has a prescription, her pharmacist might refuse to fill it.<

I seriously doubt a girl who is raped will have alot of problems getting EC. If a girl just had unprotected sex then why not ask mommy to get the EC for her. If a girl thinks she's mature enough to have sex then she's mature enough to tell mom and dad about it.

>To those who argue that we cannot trust a young woman to follow the instructions for EC (one pill now, and another one in 12 hours—it's not rocket science), I ask them, "Then why will you trust her to bear and raise a child"?<

Does anyone seriously argue this??


>A simple two-dose pack, EC is easy to use and it's safe. It contains the same medication found in birth control pills, which have been used by millions of women for decades. It has no adverse health consequences that would justify the extreme measures that the FDA is requiring in order to deny access to young women. Finally, the argument that easier access to EC would encourage promiscuity is not only insulting to young women, but there is specific evidence in the form of studies to refute that claim. Instead of sound scientific reasoning, political ideology has been the basis for this decision, as it has been throughout the approval process.<

What study? And don't parents have any say when it comes to their children?

>People across the political spectrum should be able to agree that we need to reduce the number of unintended teen pregnancies—there were approximately 235,000 in 2001 alone—and the availability of EC to all women for purchase over-the-counter is an effective way to prevent those pregnancies. NOW will continue to demand access to EC until it is approved for over-the-counter use by all women, available on store shelves (not behind the counter), and dispensed without interference.<

Yes, everyone agrees in reducing unintended pregnancies. But not every agrees on how this is to be done. I promise you that keeping your legs together will prevent pregnancy and STD's every time.
by love the last comment
"Yes, everyone agrees in reducing unintended pregnancies. But not every agrees on how this is to be done. I promise you that keeping your legs together will prevent pregnancy and STD's every time."

Keeping your legs together as in "how dare you enjoy your sexuality you dirty slut?" Sorry if you personally don't enjoy sex, but condoms break, rape happens, and your judgmental comments about women's sexuality and what they should do with it are best kept in your own righty tighty closet. I suppose you tell all your male friends to keep it zipped too? Not to mention the problems we seem to be having with the priesthood!

Young women are equally entitled to make decisions about their lives. Not all kids live in ideal loving circumstances. Even some of those who do have died of self-induced abortions because they were ashamed to tell parents. Guess that's just collateral damage if your mission is monitoring our sex lives.

Oh, and here's a link to one of the studies. I'm sure you can find the others youself. First try opening that closet door...
http://pub.ucsf.edu/today/cache/feature/200608024.html
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