Morning After Pill: Now Without A Perscription!

FDA Eases Limits on Plan B Sales
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Aug 24, 10:27 AM (ET)

By ANDREW BRIDGES


WASHINGTON (AP) - Women may buy the morning-after pill without a prescription - but only with proof they're 18 or older, federal health officials ruled Thursday, capping a contentious three-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the pills, called Plan B, the Food and Drug Administration told manufacturer Barr Pharmaceuticals Inc. (BRL)

The compromise decision is a partial victory for women's advocacy and medical groups that say eliminating sales restrictions could cut in half the nation's 3 million annual unplanned pregnancies. Opponents have argued that wider access could increase promiscuity.

The pills are a concentrated dose of the same drug found in many regular birth-control pills. When a woman takes the pills within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

The earlier it's taken, the more effective Plan B is. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays. Hence the push to allow nonprescription sales.

Barr has said it hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies - so the pharmacist can check photo identification - but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, Dr. Andrew von Eschenbach, the FDA's acting commissioner, said in a memo.

But Barr did prove that over-the-counter use is safe for older teens and adults - and licensed pharmacies are used to checking for proof of age 18 before selling tobacco and certain other products, von Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction and pledged to continue working the agency to try to eliminate it.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L. Downey, Barr's chairman.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press Thursday. Galson has acknowledged overruling his staff scientists' opinion in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

But, "I'm convinced adolescents are a different group, they require special analyses, sometimes special data," he added.

As a condition of approval, Barr agreed to track whether pharmacists are enforcing the age restriction, by, among other things, sending anonymous shoppers to buy Plan B. FDA said Barr is to conduct that formal tracking at least twice in the first year of sales and annually thereafter, and report stores that break the rules to their state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise awareness of emergency contraception, among both women and health providers.

The two-pill pack of Plan B costs from $25 to $40. A Barr spokeswoman estimated that pharmacists dispense about 1.5 million packs a year.

Nine states - Washington, California, New Mexico, Alaska, Hawaii, Maine, New Hampshire, Massachusetts and Vermont - already allow women of any age to buy Plan B without a doctor's prescription from certain pharmacies. Proponents of those pharmacy access programs believe that minors won't see any change in those states, because the pharmacist already technically writes a prescription.

The FDA approved prescription-only sales of Plan B in 1999, and the quest to sell nationwide without a doctor's note began in 2003. That year, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages, and FDA's staff scientists agreed.

But higher-ranking officials rejected that decision, citing concern about young teens' use of the pills without a doctor's oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then, last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce those age restrictions.

FDA's handling of Plan B sparked a firestorm: Critics charged that political ideology had trumped science; a reproductive-rights group sued to force FDA to settle the issue; and congressional auditors concluded the agency may have made decisions without reviewing all the evidence.

Still, nationwide nonprescription sales were widely consider a doomed issue until last month, when the FDA reversed itself and said it would reconsider if Barr agreed to an age 18 restriction. That surprise announcement came on the eve of a Senate committee hearing on whether to confirm von Eschenbach as FDA's new head.

Thursday's decision is expected to remove a Senate roadblock to his full confirmation.

"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," said Dr. Susan Wood, who resigned as FDA's women's health chief to protest the agency's 2005 delay.

But opponent Wendy Wright, president of Concerned Women for America, said Plan B's wider availability could give women a false sense of security, since it isn't as effective as regular birth control. Wright also worries that adult men who have sex with minor girls could force the pills upon them.

"Statutory rape is a very serious problem. This decision is going to allow statutory rapists to rely on this drug to cover up their abuse," Wright said.

http://apnews.myway.com/article/20060824/D8JMREMO0.html

Now that we have this readily available, can we have a serious discussion about banning abortion after the first trimester? Especially partial birth abortions?

-Kiamat Dusk

No we can't. The forums are ending in case you haven't heard.

How is it different after the first trimester? Does the embryo undergo some kind of magic transformation that makes it bad to abort it after that?

Why is there any question that a teen would not have full access to these pills? A note from a doctor, fuck that, put the shit in school lunches. Flintstone Plan B chewables.

I would eat those pills like popcorn if there were a 89% chance of not knocking someone up.

I just hope they are safe, I really don't trust the FDA anymore.

The pills sell for for US$25 / pack of 2? Prolly cost abour US$0.25 to make. And. yes, they should be given away free with the glossy teen-girl magazines.

I own my own body - Not the thirst for power church - not governments, not my mother or father - not you or any..- IF I WANT an abortion its my decision. IF NOT its still my decision.. NO ONE else have the right to order me any!

IF I want to eat pills, the man use condom or what so ever its my decision.

IF I am in a steady relation we are two about the above decision - BUT NO ONE else..

/Tina

Can someone explain to me the difference between killing your baby six months before it's born and killing your baby six months after it's born?

The end result is the same, so why is one ok and the other bad?

Pretty flowers and chocolate streams. Daffodills and happy shiny people flying. Beautiful no-sun, beautiful Stephanie, beautiful Beasley! Beautiful glorious built-in cooking timer. Hi I'm in peach buffalo in squirming tub visiting hollow beverage. Trombone pleasantry? Noodle lengthening putty service of rewinding magnitude. Scrumptious tongue mystery hat. Tommahawk, tommahawk. Aluminum monkeys festering. Lee press-on pants. Ears plugged and "lalalalalala".

Warning Will Robinson, my arms are flailing wildly. Troll bait! Troll bait!

It was a serious question.

One is a fully developed human and one isn't. One has had the chance to feel emotion and think and experience things and the other hasn't. One has gotten to have harsh flash photos taken of them and the other hasn't. One has had the chance to get ear infections from the idiotic use of fabric softener and the other hasn't. One has had the chance to use all their organs independently from their mother and the other hasn't. One has had the "wonderful" chance to have some skin off their penis removed and the other hasn't. One has made poopy diapers and the other hasn't. One has had the chance to get yelled at by abusive parents and the other hasn't.

You haven't answered the question though.

Actually, I answered with a lot of detail. Those things are the differences between killing one and the other. Killing someone before they've ever had the chance to experience anything is different than killing someone after they've had a chance to experience things. I personally think it's less humane to kill someone after they've had the chance to start experiencing life than before they've had that chance. Whether it's right or wrong to kill someone before they've had that chance to experience things I guess depends on two things--whether one is religious, and whether someone is a pessimist or an optimist. If one is a pessimist, he or she might think that it's better not to exist at all than to live in these modern times. If one is an optimist, he or she might think that life is always full of wonderful things and modern times can always get better, and any chance to experience that is a beautiful thing.

Let us that are the ones that have the embryo decide.. al others can keep away..

IF I get pregnant - the partner and I decide about it.. no one else..

I am not something that any decide about..

Info about the diff effects that can come - can be delivered from the red cross or similar.. and should be total objective.

/Tina

I believe the cutoff should be around the 8-10 week mark...when the brain and nervous system develops. I am very tired of the folks who say that a day old or week old zygote can feel pain. They never logically explain how that is possible without the nervous system. Furthermore, I'm very tired of the folks who say that a clump of cells without a brain is conscious. The human consciousness is anchored to the brain. Amputate a person's arm and they are still a conscious being. Remove a person's kidneys and give them a donor kidney and that person is still has their original consciousness, not the consciousness of the donor. Remove a person's heart and give them an artificial heart...still conscious. The only organ that is different than the others, in terms of consciousness, is the brain.

It doesnt really matter if that 2 day old embryo feels anything or is a conscious being.

What happens when you kill it is taking away every potential that embryo may have.

Like it or not you are killing a potential human being with feelings and all. Lets call him Bob or whatever.

Its not my place to judge whether you have the right to do this. As long as you can live with it....

Yeah, and every sperm is a potential human being, better not masturbate unless you can live with yourself knowing you've killed a bunch of potential people. LOL

http://video.google.com/videoplay?docid=9002085385040727366&q=every+sperm+is+sacred&hl=en

Thats my logic too! If these people believe a cell can feel pain & think, then shouldnt any blood letting be considered wrong as well? Such as donating blood?

IF thats the case then I'm the biggest killer of all time!

ok here's my thoughts on this

Abortion is ok, pretty indifferent on its morality however;

I think the potential father should have some say in the process. I know I would be emotionally devastated if a woman aborted a potential child of mine with out at least asking what I thought.

just my $0.02

You are trying to personify something that is not a person.


I agree in theory, but in practice what can the father really do? The father can say all he wants, but in the end he has no control over the woman and her body.

Looks like a "no" to me Kiamat.

true, but at least a notification requirement would be nice. Yes I know its truely the woman's choice and the father has no "real" say in the matter. I don't know, it just doesn't feel right to me, that the potential father doesn't get a say. I'm curious to know how the females feel about this idea.

So some of you are willing to decide over another body another will - without any problem?

Take away the right for me as person- to decide over my body... whats the next thing you decide about..

/Tina

Like the lady said above, its her body, she has a right to decide what to do with it... not some man in Colorado Springs, Colorado who is richer than 95% of the other Christians.