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Old 06-28-2004, 02:15 AM
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Morning after pill ruling

This article looks to be several weeks old, but i didn't see anything about it already

Quote:
U.S. lawmakers protest morning-after pill ruling
Regulators urged to immediately reconsider decision
Updated: 11:28 a.m. ET May 13, 2004

WASHINGTON - Anger over the U.S. rejection of over-the-counter sales of a “morning-after” pill simmered in Congress Wednesday as 41 lawmakers urged regulators to immediately reconsider the decision.

Critics charged the Food and Drug Administration with putting politics before science in denying Barr Pharmaceuticals Inc.’s bid to sell its emergency contraceptive, Plan B, without a prescription.

Rep. Louise Slaughter called for the resignation of acting FDA Commissioner Lester Crawford and Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.

“It is appalling that a nation with one of the highest teen pregnancy rates in the industrialized world would deny women this safe contraceptive option,” said Slaughter, a New York Democrat.

Related story
Why was Plan B rejected?

Slaughter also asked the non-partisan General Accounting Office “to investigate the serious allegations that the FDA allowed political considerations to affect its decision.”

Peter Pitts, FDA associate commissioner for external relations, said the agency stood by its decision but would consider any new application from Barr.

“We presented to Barr a bright path forward to approval,” he said.

FDA officials are willing to meet with Slaughter and other lawmakers to discuss the matter, Pitts said.

Plan B is an emergency contraceptive that can prevent pregnancy if taken within 72 hours after sexual intercourse.

Women’s groups and other supporters of switching Plan B from a prescription to over-the-counter drug argue that wider access would decrease abortions.

Opponents, including conservative groups and lawmakers, said easy access would lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.

An outside advisory panel had recommended approval by a 23-4 vote, and FDA staff scientists also supported an over-the-counter switch.

Galson said last week he decided to reject Barr’s application because there were not enough data on use of the pills by girls under 16. He said politics played no role in the decision.

Forty-one House members, most of them Democrats, sent a letter to Crawford urging the agency to quickly rethink the matter.

“This decision ignores the significant need for access to emergency contraception, including by young women,” the letter said.
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Old 06-28-2004, 04:50 AM
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Opponents, including conservative groups and lawmakers, said easy access would lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.
That is the dumbest thing I've heard in a long time. Yeah, 'cause all those kids who aren't sleeping around right now do it because they don't have access to the morning-after pill. As soon as the pill's out there, they'll start boinking everything in sight!

What they actually mean is "No, we won't let women have easy access to this pill, because then those slutty, uppity teen girls will start having sex left and right and they won't even be punished for it by getting pregnant!"

Nice to know that those conservative groups and lawmakers trust and respect women to make good decisions...
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Old 06-28-2004, 07:07 AM
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Opponents, including conservative groups and lawmakers, said easy access would lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.
That is really stupid. If people want to be sexually active, they're going to be whether they have this pill available to them or not. A thousand virgins aren't going to run to have sex just because they can get the morning after pill at the local pharmacy.
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Old 06-28-2004, 07:17 AM
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People are gonna have sex regardless, and if they are planning on doing so they'll most likely use a contraception like the Pill or a condom rather than the morning after pill. So the argument that people are gonna rush out and have sex just cos there's a morning after pill is crap.

Surely there are other varieties of MAP though? I know that here the most popular one is Levonelle which you can get non-prescription over the counter - so isn't there an alternative to Plan B?

Regardless though, that ruling is just purely stupid. As long as it doesnt provide any medical risks to the user, I see no issue with it. And as long as people are educated that it's not an alternative to using contraception (people always need to be safe), but instead is a back up in case for an emergancy.
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Old 06-28-2004, 12:51 PM
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The article link says that they will allow it to be used without perscription 16 and older, and say that there is not enough data for ages between 11 and 14. I wonder how usual it is to disallow perscriptions based on insufficient data and if this is usual for those cases.
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Old 06-28-2004, 01:24 PM
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I agree with what everyone has said so far. Making this available isn't going to make anyone just have sex more, just 'cause they can get the morning after pill easier.

But, what about the women/girls who can't get prescription contraception? If they can't get a prescription and forget to use a condom, maybe they would just resort to this. Which is fine instead of getting pregnant, but how safe is it to use just, all the time.


Quote:
Originally posted by Sparrowhawk
The article link says that they will allow it to be used without perscription 16 and older, and say that there is not enough data for ages between 11 and 14. I wonder how usual it is to disallow perscriptions based on insufficient data and if this is usual for those cases.
The article says they are looking into it being just for 16 and over. They're not sure if they want to re-submit it that way. Or to try to push for all ages.
Quote:
Spokeswoman Carole Cox said the company would now decide whether to conduct additional research on younger teens or focus on the over-16 market. Either option would require re-submitting data and waiting six months for another FDA review.
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Old 06-28-2004, 03:43 PM
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i'd argue that freer availability of condoms or other birth control would increase sexual activity? but the monring after pill? first off it's ridiciously expensive and second off why have to go through all that every time you have sex.
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Old 06-29-2004, 01:25 AM
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Consistent or frequent use of the mornign after pill can also have effects on the health - nausea etc. So its not as if people are gonna use it every time they have sex.
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Old 06-29-2004, 03:37 AM
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Oh my god! I was so surprised that he wasn't possible to have it here!!

That's so crazy.. can't beleive you can't .. Of course it's not a game but still that can be really useful in some case
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Old 06-29-2004, 03:55 PM
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Well you can get it, but you have to go to a doctor and ask for it.
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Old 06-29-2004, 04:37 PM
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I'm not sure I like the idea of it being available over the counter. It's not like it's difficult to get, you just go by a planned parenthood which is probably a good idea if you are having unprotected sex then they could probably urge these girls to be more careful, give them condoms, etc.
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Old 06-30-2004, 03:17 PM
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I agree with the decision to keep it as a prescription, although I don't agree that making it available would increase the chances of unprotected sex. The article fails to mention everything that the body will go through when you take Plan B-- it throws the menstrual cycle off (to the point where it could take months before regularity), there's breakthrough bleeding, nausea, cramping and possible vomitting. Plus, it's only about 89% effective and that effectiveness drops the longer the person delays taking it. Even though the official site says repeated use isn't harmful, I can't see how that can be. It would be throwing the menstrual cycle off and someone who's actually pregnant can mistake a missed period for just being a side effect of Plan B.

It's not difficult to get it as it is now, so I don't really see the need for it to be an over the counter drug.
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Old 06-30-2004, 10:30 PM
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The morning after pill is an extremely high dosage of the same hormones that are in birth control pills. If birth control pills aren't available without a prescription, why should an extremely high dosage of birth control be available without a prescription? It just doesn't make any sense, to me at least.
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