The secretary of Health and Human Services overruled Wednesday a Food and Drug Administration recommendation that would have made the emergency contraceptive pill Plan B One-Step available over the counter to girls younger than 17.
In February, Teva Woman's Health Inc, the drug maker, had asked the FDA to make the drug available without prescription to all sexually active girls and women.
At the time, FDA Commissioner Dr. Margaret Hamburg said that, after reviewing all relevant data, "Plan B One Step is safe and effective and should be approved for non-prescription use for all females of child-bearing potential."
But HHS Secretary Kathleen Sebelius overruled that recommendation. "Because I do not believe enough data were presented to support the application ... I have directed FDA to issue a complete response letter denying the supplemental new drug application," she said in a statement.
In July 2009, Plan B was approved for use without a prescription for females aged 17 and older, but girls under 17 needed a prescription.
Emergency contraceptives prevent a pregnancy by preventing a fertilized egg from embedding in the uterus. They are intended for use within 72 hours after sex, but are most effective if taken within 24 hours. Proponents say requiring a prescription can delay access to the drug.
Wednesday's decision was criticized by the American Society for Reproductive Medicine, which counts more than 8,000 members.
"We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA," said the group's president, Dolores J. Lamb. "The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health."
But Dr. Lisa Flowers, associate professor in the Department of Obstetrics and Gynecology at Emory University's School of Medicine, said Sebelius' decision "might be the right thing to do until we get a really good system by which we can educate young kids about prevention of pregnancy and understanding the risks of getting involved in sexual intercourse, and what are the outcomes."
Flowers suggested the FDA consider allowing over-the-counter access for girls under the age of 17 if they are accompanied by a parent to the drugstore.
Under chrissy, 12:12 and 12:18 on this thread.
I can put another broswer on my phone? Really? Of course, prolly not, I have a crackberry.
Ok, Jeff, report the one trolling me @12:50.
@saywhat...who are you?
Threads are for discussing the topic ,why is this troller still around?
Why can men buy condoms? There is no age limit on these so what is the big deal? If this nation continues on this tract soon we will not be allowed to use any type of birth control or have abortions and we will have more and more unwanted unloved abused babies. A loved wanted child is so wonderful but otherwise so sad.
....bypassing parental authority...FDA now abusing its office setting illicit political agendas and political policies, feeding an pro-choice agenda...where your objectivity? permitting unsafe drugs and not protecting the public...why so herodian against citizens? who are you trying to prevent from coming into this world? this panel has been sold to the highest bidder and need to be removed...you are not serving the American people...
you're nothing buttah panel and adminstrators of turtle eggs lovers...(spit!)
I agree with the FDA. It should be available to anyone who needs it. And no parents required! Some kids don't have parents that they can go to with thier problems.
If its needed then it should be accessable. the world is overpopulated and under-cared for. it doesnt mean go do what u want but its better that there is at least a solution bc teens are gonna do what they want anyway.
I think it is important that I minor is treated as a minor. yeah... they screwed up... literally, but that doesn't mean they don't have enough time to go to a doc and get a script. 72 hour window people. It's better that they talk with a health care professional before taking this willy nilly. Plan B should not be used like a condom. If you put it OTC then it will be used as such. It's not that they are trying to take away a "woman's right" (they are CHILDREN after all) ... they are trying to make it a more educated and guided buy.
So an OTC morning after pill would now be available to boyfriends/husbands. Putting it in her breakfast to prevent children. I would think the Pro Choice would not be for this because the choice is now potentially out of the woman's hands and into the person who chose not to wear a condom. Are there any other OTC medicines that can have such an effect.
Pro-Choice means that we believe that the woman has the right to control her own body, not that someone else has the right to control her own body. How stupid are you?
Men are able to purchase it anyway, as long as they are 17.
So....we trust sixteen-year-old girls with enormous automobiles that could kill them and everyone who gets in their way, but not with their right to prevent unwanted pregnancy? Genius. Gotta love this country.
No how stupid are you. I know what Pro Chioice means. Learn how to understand the words written. I am saying that with the morning after pill available OTC, anyone can get it and impact a woman's choice. If someone gave her the pill without her knowledge, then her choice is taken away.
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