FDA decision on teens, "morning-after" blocked
WASHINGTON - In a surprise move, the nation's health secretary stopped the Plan B morning-after pill from moving onto drugstore shelves next to the condoms, deciding Wednesday that young girls shouldn't be able to buy it on their own.
The Food and Drug Administration was preparing to lift a controversial age limit and make Plan B One-Step the nation's first over-the-counter emergency contraceptive, available for purchase by people of any age without a prescription.
But Health and Human Services Secretary Kathleen Sebelius intervened at the eleventh hour and overruled her own experts.
Plan B instead will remain behind the pharmacy counter, as it is sold today — available without a prescription only for those 17 and older who show an ID proving their age.
Sebelius' reason: Some girls as young as 11 are physically capable of bearing children, and Plan B's maker didn't prove that younger girls could properly understand how to use this product without guidance from an adult.
"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said in a statement. "I do not believe enough data were presented to support the application to make Plan B One-Step available over-the-counter for all girls of reproductive age."
It was the latest twist in a nearly decade-long push for over-the-counter sales of pills that can prevent pregnancy if taken soon enough after unprotected sex. Major doctors' groups and women's health advocates say easier, quicker access to those pills could cut the nation's high number of unplanned pregnancies.
The decision shocked maker Teva Pharmaceuticals, which had been gearing up for over-the-counter sales to begin by month's end, and women's health groups.
"We are outraged that this administration has let politics trump science," said Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group. "There is no rationale for this move."
"What else can this be but politics?" said Cynthia Pearson, executive director of the National Women's Health Network, an advocacy group that supports making Plan B available to all ages. "It's not science. It's not medicine. It's not women's health."
Indeed, FDA Commissioner Dr. Margaret Hamburg made clear in her own statement that the decision is highly unusual. She said her agency's drug-safety experts had carefully considered the question of young girls and that she had agreed that Plan B's age limit should be lifted.
"There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg wrote.
But, she added, she had followed her boss' order to deny Teva's application.
"We commend the FDA for making the recommendation ... and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," said a statement Teva issued Wednesday.
The company said it would review the decision before determining next steps.
Already, the FDA's age limits have gone to court. In 2009, a federal judge said the agency had set them initially based on politics, not science, and ordered the agency to reconsider. A hearing already was scheduled for next week to consider whether the FDA should be held in contempt of court for not doing so earlier.
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It's time to stop living in this fantasy dream world, stop harassing people who find children and teenagers sexually attractive, and start giving children and teenagers the information they need to make their own sexual choices.
Doing that worked for my daughters, it worked for my relatives daughters, it would work for other people's children.
The only thing this decision is about is trying to foist religious 'morality' (really someone's personal likes and dislikes that they think that they have the right to force on other people) on people.
I can see all sort of liberal benefits.
#1 No medicines to avoid getting pregnant.
#2 if eggs are drawn out randomly then everyone has equal opportunity to be born.
#3 random eggs will end discrimination because you don't get to choose sex or race of child.
Oh yeah I could go on and on about this.
And best yet? Al-Quaeda would have equal chance to win world domination by taking out a few big national egg banks -- ending continuance US liberal and conservative ideas in an instant of inattention.
...unless we open up those borders to anyone who wants to be immigrant!!!!
That being said, a drug to get rid of syphillis, a drug to get rid of the baby....what's the difference? The difference is that a baby is not a disease. Inconvenient at 13 years old, but not a disease. And the really sad part is that this is what we are teaching our little girls and boys...it's OK to have sex at 12 years old, don't worry, it can all be fixed with a little pill. The trauma of making the choice to go in and have a surgical procedure...to have to really think about it....to have to go and walk thought the crowd of right-to-lifers screaming at you, if nothing else, it can be a deterrent. I don't want it to be as easy as buying a cup of coffee. I want my daughter, if it ever came to that, to have to THINK about it, and to suffer the consequences of her actions. And if my son doesn't learn from us how to control his hormonal impulses, I want him to have to endure the fear and anxiety and pain that he helped put some teenaged girl through.
These are children. They need guidance and support and strong role models, not another easy way out of their mistakes.
If it is then the Secretary probably made the best ruling.
Because accidental poisoning cases (especially simple medicines like aspirin) continues through age 12 for example. If you worry about diet drugs in underage hands, you probably should worry about any other drugs with possible overdose or strong side effects -- regardless of "social advancement".
Plus I have known plenty of idiot young girls who would panic and take 10 or even 100 doses just to be extra sure. Sure they are only 5-10% of all girls ...but they are probably also the one most likely to feel the need to use this product.
Perhaps the rule can be amended to allow treatment to be taken under supervision of pharmarcy personnel or any number of local adult organizations (Planned Parenthood, Social worker, school guidance counselor, etc).
Prevent Unwanted Pregnancy
or Build more Jails for Unwanted Children
For Crying Out Loud Woman, have you no humanity?
Respectfully,
Treesa Szymkiewicz