No Need for a Plan B for Plan B
August 24, 2006 7:49 AM   Subscribe

[NewsFilter] A partial victory for public health over politics. Amazingly, the FDA has finally, after 3 years of wrangling, approved over-the-counter sale of Plan B, an emergency contraceptive pill. The victory is partial because you need to be 18 or older to purchase it without a doctor's note. If you're under 18, you need to still have documentation from your physician (or nurse practitioner). The politics behind the approval process were laid bare in this (sincerely) fascinating GAO report [note: links to .pdf file]. I also hope that OTC approval will avoid this.

Plan B previously discussed on MeFi here.
posted by scblackman (65 comments total) 1 user marked this as a favorite

 
Finally!
posted by bshort at 7:58 AM on August 24, 2006


There is more fascinating information at the FDA CDER (Center for Drug Evaluation and Research) page on Plan B. It's also probably a good day to own some stock in Barr Pharmaceuticals (if you're into the whole stock market/capitalist thing).
posted by scblackman at 8:05 AM on August 24, 2006


Finally is right. I am absolutely estactic about this!
posted by agregoli at 8:08 AM on August 24, 2006


This is good news, even with the caveats.
posted by OmieWise at 8:08 AM on August 24, 2006


Or, you know, ecstatic.
posted by agregoli at 8:08 AM on August 24, 2006


I've already taken 5 of them this morning!
posted by BobFrapples at 8:14 AM on August 24, 2006


Awesome. 18 year olds will be walking around with pockets full of these. I am sure that it will be easier to get than beer for women under 18.
posted by Mr_Zero at 8:19 AM on August 24, 2006


Is it a victory over politics? Unlikely.
posted by thirteenkiller at 8:24 AM on August 24, 2006


Excellent.
posted by needs more cowbell at 8:24 AM on August 24, 2006


Finally! Time to start having sex without any concern at all for the consequences! Look out ladies, here I come!
posted by dios at 8:25 AM on August 24, 2006


Thirteenkiller: well said. I should rephrase the title. Perhaps, "A victory despite politics."
posted by scblackman at 8:28 AM on August 24, 2006


Like that wasn't going on already, dios.
posted by Roger Dodger at 8:36 AM on August 24, 2006


Yeah dios, 'cause escaping the consequences of sex should be a male only privilege. Those filthy whores should be forced to take full responsibility for both parties actions.
posted by substrate at 8:36 AM on August 24, 2006


The agency has decided to rely on voluntary compliance with the rules, since neither federal drug regulators nor Barr plans to police the age restriction.
posted by smackfu at 8:37 AM on August 24, 2006


dios writes "Finally! Time to start having sex without any concern at all for the consequences! Look out ladies, here I come!"

Finally! Now that we have the SDI "Star Wars" Missile Defense shield, it's time to start lobbing nuclear missiles without any concern at all for the consequences! Look out former Soviet Union, here they come!

Finally! Now that I have automated tape backups of my hard drive, it's time to never run my virus-checker again without any concern for the consequences! Look out harddrive, here comes (c)Brain!

Finally! Now that I have the police and the DHS and the PATRIOT Act, we can trash the Second Amendment without any concern at all for the consequences! Look out Charlton Heston, I'm coming to pry that gun out of your cold dead hands!

Finally! Now that I have car insurance, it's time to get rid of my seat-belt and start cruising at 120 miles per hour without any concern for the consequences! Look out slow-pokes, here I come!
posted by orthogonality at 8:37 AM on August 24, 2006 [5 favorites]


Time to start having sex without any concern at all for the consequences!

Well, y'know except for all those nasty diseases and whatnot.

And actually consensual sex without the worry of pregnancy? Sounds fun to me.

I'm having trouble parsing if this is straight humor, or sarcasm So I think I'll go somewhere else.


oh, and Yay!
posted by edgeways at 8:39 AM on August 24, 2006


Whatever happened to "Don't feed the trolls"? Or does only apply to everyone else?
posted by SeizeTheDay at 8:42 AM on August 24, 2006


Or does that only apply...
posted by SeizeTheDay at 8:43 AM on August 24, 2006


Well I laughed.
posted by kableh at 8:44 AM on August 24, 2006


This is definately good news, but the age limit is pretty twisted. Is there any reason why we shouldn't try to make the seemingly more hazardous possibility of teen pregnancy (as opposed to adult pregnancy) less frequent?

I read the nytimes article, but they didn't really offer an explanation. Did anyone else dig anything up?
posted by Alex404 at 8:46 AM on August 24, 2006


Well, the argument that the religious right was using to blockade Plan B for so long was that it might be dangerous for teenagers to use. THis was a claim made without much actual science to back it up, of course, but it was repeated so often and so fervently in the debate that eventually they had to give this concession in order to let the pill pass at all.
posted by Navelgazer at 8:50 AM on August 24, 2006


Here's to many safe journeys out the cervical os for all the unimplanted zygotes.
posted by i_am_a_Jedi at 8:51 AM on August 24, 2006


By allowing those under 18 to have unfettered access to Plan B, we would only be encouraging them to have pre-marital sex. By requiring them to see a doctor to get it, they will be sure to think twice before getting knocked up. And besides, any young woman who is having unprotected sex should probably talk to her doctor anyway.

For those with non-functioning sarcasm meters, this one rates about halfway up the scale.
posted by Roger Dodger at 8:55 AM on August 24, 2006


This is good news. As for it still being available only by prescription for those under 18: that is odd, but it's worth noting that the regular contraceptive pill is available only by prescription, and Plan B has the same ingredients but in higher concentration. Maybe the next step is to make contraceptive pills available over the counter?
posted by Marla Singer at 8:57 AM on August 24, 2006


I think dios was being sarcastic? Maybe?
posted by thirteenkiller at 8:59 AM on August 24, 2006


Finally! Time to start having sex without any concern at all for the consequences!

Finally! Time to start shitting in threads without any concern at all for the consequences!
posted by BobFrapples at 8:59 AM on August 24, 2006


Alex404: The 'rationale' that Andrew Von Eschenbach (Acting FDA commissioner) gave was that:

1. There are age restrictions (age >18) for other O-T-C products such as nicotine replacement therapy, cold medicine containing pseudoephedrine.

2. That 18 is the age of majority in all 50 states.

3. That CDER found that the manufacturer (Barr Labs) "had not established that Plan B could be used safely and effectively by young adolescents (16y or younger) ... without the professional supervision of a practitioner licensed by law to administer the drug."

You can read his letter here (Note: links to .pdf).
posted by scblackman at 9:00 AM on August 24, 2006


And besides, any young woman who is having unprotected sex should probably talk to her doctor anyway.

And they should have to bring their parents to the doctor visit for moral support.
posted by Mr_Zero at 9:02 AM on August 24, 2006


Abstinence education, independent of HIV or other common STD infection rates, fails miserably. There are several established statistical studies published on this matter (example).

Educating women about birth control and reproduction options has been demonstrated to work successfully to reduce HIV and other STD rates in Africa and Southeast Asia. This, too, is fact established in peer-reviewed statistical studies.

Therefore, given two options, both of which the general outcomes are well-established and ground in factual, reality-based research, most rational, thoughtful human beings who consider the public health consequences of not providing emergency contraception (among other options) would probably do well ignore the troll's comment.
posted by Blazecock Pileon at 9:06 AM on August 24, 2006


BobFrapples!: Finally! Time to start shitting in threads without any concern at all for the consequences!

Flag and move on.

This is a great thing for two reasons:

1: I've had more than my share of "oh $&*!, it broke/slipped" moments followed by a few weeks of nail biting.

2: I've unfotunately had my share of friends who have been raped.
posted by KirkJobSluder at 9:08 AM on August 24, 2006


Wow. Some of y'all have serious sticks up your ass. My comment was supposed to be light-hearted and funny... and I guess my obvious double entendre about "Here I come" wasn't obvious nor funny.

I didn't think this was such a serious issue for some people that joking is not allowed.

Me? I like this. It would have made my college days a lot less stressful on several occasions because we all do things we regret the next morning or something. But its obviously not supposed to be relied on as a primary birth control device, and that is what I was joking about. After all, everyone knows the primary birth control device is pulling out.
posted by dios at 9:12 AM on August 24, 2006


dios,

In a world where people didn't make that argument seriously, it would have been funny. :-)
posted by callmejay at 9:17 AM on August 24, 2006


Seconded, dios.

Coitus Interruptus: Works Perfectly Until It Doesn't

And yes, I know that you were joking.
posted by Navelgazer at 9:20 AM on August 24, 2006


Exclamation points generally mean that a person is joking. Three exclamation points in three consecutive sentences is a really good indication that someone is joking.
posted by flarbuse at 9:40 AM on August 24, 2006


I was referring to the later posts, but whatever.

My question is, could the Rx decide not to fill a ritalin prescription because he thinks it's overprescribed? Or does this line of thinking only apply to those causes with a sizable lobby?
posted by Navelgazer at 9:46 AM on August 24, 2006


[C]ould the Rx decide not to fill a ritalin prescription because he thinks it's overprescribed?

Pharmacists can presently refuse prescriptions for any basis they see fit. Some chain pharmacies are developing corporate policy to ensure customers with legal, valid prescriptions will receive healthcare products, regardless of the pharmacist's personal morality. Other corporations are working to write policy with fundamentalist Christian organisations, which refuses the sale of medical products for arbitrary moral reasons.
posted by Blazecock Pileon at 9:55 AM on August 24, 2006


Hey, minors won't even need Plan B as soon as there is finally some funding for abstinence only education!!!
posted by Skwirl at 10:00 AM on August 24, 2006


There were some kids in my high school that were to poor to pull out.
posted by Mr_Zero at 10:05 AM on August 24, 2006


Dios, I think you would have been more interested in the long approved Plan C contraceptive device.

Sure you've hear of it? Upon use it immediatly changes your name to Mr. Smith and provides you a ticket to Anchorage, Alaska.
posted by tkchrist at 10:09 AM on August 24, 2006


Funny, I didn't feel at all celebratory when I read this in the paper this morning. Perhaps because I feel the people most in need of an easily accessible morning after pill are the under-18s. These are the women who would be most harmed by becoming pregnant but paradoxically are the most likely to engage in unprotected sex. We live in a very odd society where the 15-year-old gracing the cover of Cosmo magazine and the 16-year-old shaking her poms poms at the football game are considered the height of sexually attractive perfection but their actual sexual behavior is meant to be under the control of their parents. Here are just a few of the mixed messages we send as a society:

Your greatest asset as a female is your desirability.

You, the female, are not to engage in sexual activity until you come of age and leave your parent's home.

You, the male, are allowed to use any means necessary (short of physical intimidation) to convince your partner to engage in intercourse.

Perfection is possible; if you try hard enough, you can remain pure in thought, word, and deed. Anything short of perfection is subject to penalty.
posted by Secret Life of Gravy at 10:28 AM on August 24, 2006


I'm celebratory because not only can women 18 or older now get it, but underage women will be able to get it too - it won't be long before there are networks for access to this thing.

I wish it was for younger folk too, but for now, this is an ENORMOUS victory. We've been waiting a long time for some good news regarding reproductive freedom, and I'm really enjoying it.
posted by agregoli at 10:35 AM on August 24, 2006


But how much is it going to cost? Will it be too expensive for many who need it?
posted by tippiedog at 11:15 AM on August 24, 2006


I know that I, for one, and several of my friends, for another, would be happy to pony up for some in order to give it to someone who needs it.

But I wonder about the cost as well.
posted by agregoli at 11:29 AM on August 24, 2006


But how much is it going to cost? Will it be too expensive for many who need it?

Any young women with access to Planned Parenthood should be able to get it on a sliding-scale fee. Too bad PP is under constant attack from the religious right and not present at all in many poor, rural, conservative areas that could really use it.
posted by Marla Singer at 11:39 AM on August 24, 2006


What's the opposite of "."? 'Cause that's what I think about this. More disturbing than this approval taking so long is that I found myself thinking in punctuation.
posted by ruby.aftermath at 11:46 AM on August 24, 2006


1. There are age restrictions (age >18) for other O-T-C products such as nicotine replacement therapy, cold medicine containing pseudoephedrine.

2. That 18 is the age of majority in all 50 states.

3. That CDER found that the manufacturer (Barr Labs) "had not established that Plan B could be used safely and effectively by young adolescents (16y or younger) ... without the professional supervision of a practitioner licensed by law to administer the drug."


That's what I read, and it's been bothering me more and more. When you first read these reasons, they don't seem so distressing, but then you realize that the only real reason why that most critical group, the 17 and 18 year olds, are not getting plan B is beauracratic incidence. I mean, what the fuck? Teen pregnancy is a huge problem but given certain allowances to convenience we'll just have to accept it?

I know I'm overgeneralizing a little, but reading this guys later makes me feel like he doesn't actually realize there's a problem that this drug is attempting to deal with. That it is in fact in the same category as cold medicine as a 'pleasent solution to modern living'.
posted by Alex404 at 12:15 PM on August 24, 2006


Huh. I'm surprised that nobody here has mentioned this yet, and more surpised that even the media reports haven't drawn the connection. Senators Hillary Clinton (NY) and Patty Murray (WA) put their collective foot down a few weeks ago and blocked the confirmation of an FDA commissioner. "Once we start politicizing the FDA there is no stopping and from my perspective it is essential that we draw a line, and we’re drawing a line right here."

Looks like it worked.
posted by intermod at 12:23 PM on August 24, 2006


As difficult as it is for me to say this, more power to H.Clinton for helping to push this through.
posted by SeizeTheDay at 12:38 PM on August 24, 2006


BTW, I can understand why so many people here are outraged that girls under 18 can't get this without a prescription, but at least it was passed in some form. There are plenty of medications (like RU486) that will never make it to the States because of how conservative the FDA and medical establishment in this country has become. This is at least a step in the right direction (contraceptive rights), which we should all be happy for.
posted by SeizeTheDay at 12:41 PM on August 24, 2006


have become...Damnit, twice in 24 hours now.
posted by SeizeTheDay at 12:41 PM on August 24, 2006


HORRAY!!!!!
posted by eatdonuts at 12:47 PM on August 24, 2006


ruby.aftermath Maybe the opposite of "." is "!"?
posted by sotonohito at 12:58 PM on August 24, 2006


or ,
posted by owhydididoit at 1:14 PM on August 24, 2006


Oh, and Yay! As for the age restrictions, I think it's wrong, but as others have pointed out, it seems unlikely to keep anyone from getting Plan B.
posted by owhydididoit at 1:17 PM on August 24, 2006


Fucking sweet. It's about damn time.


*hugs seasonale pills*
posted by sperose at 1:52 PM on August 24, 2006


On an aside, Ruby.aftermath, I've been on MeFi for months now, and have never figured out what "." is supposed to mean. Help, please.
posted by Navelgazer at 2:23 PM on August 24, 2006


Tears.
posted by Eyebeams at 3:02 PM on August 24, 2006


I think.
posted by Eyebeams at 3:07 PM on August 24, 2006


Navelgazer, faq.
posted by intermod at 3:43 PM on August 24, 2006


Thanks.
posted by Navelgazer at 10:39 PM on August 24, 2006


I wonder if pharmacies and chains will just decide not to stock it now?
posted by amberglow at 11:00 AM on August 25, 2006


Huzzah, another chance for embarrasment at the checkout counter! "PRICE CHECK ON PLAN B -- ANYONE KNOW HOW MUCH THIS MORNING AFTER PILL IS?"
posted by brain_drain at 2:05 PM on August 25, 2006


The True Face of Abortion Opponents
posted by homunculus at 12:51 PM on August 27, 2006


it's so true, hom--contraception is next on their attack list, and they've suceeded in getting condoms and realistic sex ed out of many many schools all over already (and when you put it together with shit like Buchanan's "save whites" and all the anti-brown people campaigns, it's very telling.)
posted by amberglow at 5:01 PM on August 27, 2006


Put away the party hats --... The agency’s suggestion that Barr Labs should reapply to sell Plan B OTC to women 18 and older is indefensible. There is no more medical justification to restrict Plan B sales to women 18 and older, than it is for sales of the drug to be restricted to males only. ...
We have won the battle to get Plan B sold over the counter. But we have lost three very big battles:
1) The battle to reduce the underage unplanned pregnancy rate. ...
2) They’ve worked opposition to contraceptive use into mainstream discourse. ...
3) Abortion “opponents” have made sure that the abortion rate stays nice and high, which is what they really want. ...

posted by amberglow at 2:52 PM on August 28, 2006


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