FDA to allow 'morning-after' pill for 17-year-olds
By RICARDO ALONSO-ZALDIVAR
Women's groups cheered the government's decision to allow 17-year-olds to buy the "morning-after" emergency contraceptive without a doctor's prescription, but conservatives denounced it as a blow to parental supervision of teens.
The Food and Drug Administration said Wednesday it would accept, not appeal, a federal judge's order that lifts Bush administration restrictions limiting over-the-counter sales of "Plan B" to women 18 and older. U.S. District Judge Edward Korman ruled last month in a lawsuit filed in New York that President George W. Bush's appointees let politics, not science, drive their decision to restrict over-the-counter access.
Women's groups said the FDA's action was long overdue, since the agency's own medical reviewers had initially recommended that the contraceptive be made available without any age restrictions.
Korman ordered the FDA to let 17-year-olds get the birth control pills. He also directed the agency to evaluate clinical data to determine whether all age restrictions should be lifted.
The FDA's latest action does not mean that Plan B will be immediately available to 17-year-olds. The manufacturer must first submit a request.
"It's a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science," said Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit.
Conservatives said politics drove the decision.
"Parents should be furious at the FDA's complete disregard of parental rights and the safety of minors," said Wendy Wright, president of Concerned Women for America.
Plan B is emergency contraception that contains a high dose of birth control drugs and will not interfere with an established pregnancy. It works by preventing ovulation or fertilization. In medical terms, pregnancy begins when a fertilized egg attaches itself to the wall of the uterus.
If taken within 72 hours of unprotected sex, it can reduce a woman's chances of pregnancy by as much as 89 percent.
Critics of the contraceptive say Plan B is the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus. Recent research suggests that's possible but not likely.
The battle over access to Plan B has dragged on for the better part of a decade, through the terms of three FDA commissioners. Among many in the medical community, it came to symbolize the decline of science at the agency because top FDA managers refused to go along with the recommendations of scientific staff and outside advisers that the drug be made available with no age restrictions.
"The FDA got caught up in a saga, it got caught up in a drama," said Susan Wood, who served as the agency's top women's health official and resigned in 2005 over delays in issuing a decision. "This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas."
The treatment consists of two pills and sells for $35 to $60. Women must ask for Plan B at the pharmacy counter and show identification with their date of birth. The drug is made by a subsidiary of Teva Pharmaceutical Industries, an Israeli company. It does not prevent sexually transmitted infections, such as HIV/AIDS.
Supporters of broader access argued that Plan B is safe and effective in preventing unwanted pregnancy and could help reduce the number of abortions.
Opponents, including prominent conservatives, counter that it would encourage promiscuity and might even become a tool for criminals running pros ution rings, as well as for sexual predators.
Early in the Bush administration, more than 60 organizations pe ioned the FDA to allow sales without a prescription. But according to court do ents, the issue quickly became politicized.
In 2003, a panel of outside advisers voted 23-4 to recommend over-the-counter sales without age restrictions. But top FDA officials told their subordinates that no approval could be issued at the time, and the decision would be made at a higher level. That's considered highly unusual, since the FDA usually has the last word on drug decisions.
In his ruling, Korman said that FDA staffers were told the White House had been involved in the decision on Plan B. The government said in court papers that politics played no role.
In 2005, the Center for Reproductive Rights and other organizations sued in federal court to force an FDA decision.
The following year, the FDA allowed Plan B to be sold without a prescription to adults. But the controversy raged on over access for teens
At least conservatives are being more honest about their motives for being against this. It was never about abortions it is rather about not wanting teens to have sex.
So if conservtaives were successful in keeping this away from teens there would actually be more abortions.
Nice job guys.
In general, is it a good thing for teens to be having sex? It's not like many parents are that responsible themselves. (Yes, I know, they'll do it no matter, etc...) I'm just wondering why the thought that teens having sex isn't a good thing is a bad thing.
I think teens NOT having sex is a good thing. My progressive thinking ass preaches abstinence at home and I've got a 15 yr. old daughter who has blossomed and it scares the out of me.
I think everyone is en led to their opinions. But at some point you have to take a look outside, realize teens are doing it, and you need to address the issue regardless of what you believe in.
Right. Should it be the business of the state to educate your daughter about sex? It seems to be that it's your family's business and not that of the state (no matter what 'education' it wants to deploy - i.e. abstinence programs or handing out condoms).
I concur. I just sometimes think that teens take that as a "it is okay to do it" message just make sure he wears a condom.
Why does the state have to address it?
Teenage pregnancy is one of the reasons abortion has the support it does. Of course, the poor and non-whites account for a disproportionate share of abortions in the US.
Well I don't have any issues with sex education when it is about the life cycle but I don't want anyone else giving my kids condoms. That being said I do think it is good for young kids to have a place to go if they don't have parents or guardians they can go to to talk about sex and STD's.
While that may be true the non-poor get many abortions too but then again they probably are not going to a clinic to get it taken care of. And many whites too.
I am against emergency contraceptives. They are for the sexually immoral. For example, the 17-year-old I'm seeing in the Virginia suburbs.
With no scientific backup or research on this whatsoever, I have to wonder if teenage sex - assuming those teens still live with their parents and under SOME form of rule structure - might ease the entry into sexual maturity a little more healthily than the sudden burst of no-holds-barred promiscuity that some kids experience when they get to college.
Sure, whites get it done too, but there seems to be an unspoken notion in our society that abortion is good as it culls the number of 'unwanted' children in certain demographic groups. It's a sad commentary that children would be unwanted in our society, particularly when the pregnancy is otherwise normal and not due to rape or incest.
As for abortion itself, the fetus is an individual. The question is, to what extent should the state interfere to protect that individual, while respecting the rights of the mother and father? It's often heard that abortion should be prohibited except in cases of rape and incest. Well, how does a woman sufficiently establish that the pregnancy is due to rape? That seems to be the point at which it gets hazy for the anti-abortion argument, at least in the first trimester.
In a roundabout way, this country may have gotten it right, with abortion available in the first trimester. Count on the parents to make a wise decision with minimal state involvement. Still, there are 800k abortions per year in the US (though it has declined somewhat over the last decade).
The morning-after pill does reduce the time and effort for an abortion, which would seem to reduce the penalty for not being more cautious in practicing safe sex. Though, obviously, it would make it much easier for a woman who has been raped, and I don't have a problem with that.
A majority of Americans oppose abortion and a majority think that it should be legally available in some form. I think we generally have it right, but I do have a problem with it when it's used as a form of birth control more so than in those sad situations of rape.
I concur. Well said and I agree that abortion is used as a form of birth control and that is sad.
True, but all children face other significant limitations due to their childhood, be it economic, social, and/or emotional. At what point should the state not meddle with the family?
And, is teens experimenting with sex, even under some structure, desirable? Yes, parents should be open and honest about sex with their children, but if the price of dealing with an unwanted pregnancy is low, why bother?
It's been said increased abortion was the main reason crime decreased during the 90's.
So then we should all agree to try and limit as many abortions from happening as possible.
What are you trying to get at? The state should not be meddling in personal matters is what I am gathering.
I hear that there is this college culture wherein people who don't view having sex with other people as something akin to playing Yahtzee with them or watching Star Wars are considered strange and are pressured to put out no-holds-barred. Where does this exist? It didn't exist when I went to college 15 years ago, and it doesn't exist today in the Texas colleges or those in surrounding states as far as Illinois where the children of my friends and loved ones go.
I mean, yes, there were copious opportunities to have sex, of which many people took ample advantage, but having an at ude of "gee, I really don't want to deal with the relational, emotional, and possibly physical consequences of having sex with this person" was considered entirely normal and acceptable. It was not a four-year orgyfest. Most people spent most of their time, um, studying.
Because the state ends up footing the bill for a lot of this unwanted kids. I'm not saying they need to address the moral aspect, but it's undeniable there's an economic aspect to it that needs to be addressed.
That's part of the logic, but I thought the state was supposed to serve us, not the other way around.
The first time I experienced "hook-up" sex was back in 1980 when I was in the service and I really didn't want to deal with relationship BS because I just wanted to screw around and enjoy my youth. During college I also had a hook-up for sex and it was no big deal. From what I hear today regarding kids in their early teens hooking up and that oral sex is no big deal shocks me.
Well, generally. But I do concern myself with the rights of the individual. A fetus is an individual. I'm not going to pretend that this is some black and white matter, nor am I going to color it with faith as I'm not sure that serves anyone well.
I'd prefer the state to leave it up to the family to deal with matters of sex, much like many would prefer to leave it up to them to decide what's the appropriate sex life. Though I do think it's best that teens not engage in sex when they aren't ready to deal with the consequences (though that shouldn't be a state matter).
The state isn't *replacing* one service with another. It's merely providing an additional service for those that do not wish to carry on with the pregnancy.
In the long run, it's in the state's best interest that this service is provided, economically speaking.
But the state does leave it up to the family to deal with matters of sex. They're merely allowing a certain demographic to have access to a certain contraceptive if they choose to use it. The state isn't forcing anybody to make decisions.
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