FDA approves morning after pill for over the counter!
 

FDA OKs wider access for Plan B pill By Lisa Richwine
Thu Aug 24, 10:30 AM ET

Adult women can buy a "morning-after" contraceptive without a prescription, U.S. health officials said on Thursday after a three-year political battle over wider access.

Barr Pharmaceuticals Inc.'s (NYSE:BRL - news) Plan B must stay behind pharmacy counters, the Food and Drug Administration said. Women must show proof they are at least 18 to buy the emergency contraceptive pills without a prescription, and younger girls still need a doctor's order.

"When used as directed, Plan B effectively and safely prevents pregnancy," the FDA said in a statement.

Backers and opponents had fiercely lobbied the agency with arguments about Plan B's impact on abortion rates and teen sex, and the feud stalled the nominations of two FDA commissioners.

Two Plan B pills can prevent pregnancy when taken within 72 hours of sexual intercourse.

Women's groups and other supporters argued easier access would reduce the number of unwanted pregnancies and abortions. Conservative opponents said wider availability would lead to more teen-age promiscuity and sexually transmitted diseases.

Barr agreed to monitor enforcement of the age limit and to limit Plan B's distribution to health clinics and stores with pharmacies, the FDA said. The pills should be available in dual nonprescription and prescription packages by the end of the year. Prescription packages are available now.

"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," Barr Chief Executive Bruce Downey said in a statement.

The company originally had sought permission to sell Plan B over the counter without age limits.

Throughout the process, two Democratic senators blocked votes on President George W. Bush's nominees to run the FDA.

After the FDA decision, Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York dropped their objections to a Senate vote on the confirmation of Bush's current pick, acting FDA Commissioner Andrew von Eschenbach, a Murray spokeswoman said.

Since Barr's initial bid in April 2003 to allow sales of the contraceptive without a prescription, repeated delays sparked charges that the FDA let politics override science.

In December 2003, a panel of outside advisers voted 23-4 to recommend switching Plan B from a prescription to over-the-counter drug. FDA staff scientists agreed, but a senior official rejected approval over concerns that young girls might not be able to use the pills safely.

Barr submitted a new bid for over-the-counter sales to females 16 and older. The FDA deferred a decision on that plan and last month proposed the 18-and-older scenario.

Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills. Women are supposed to take two tablets 12 hours apart.

The pills block the release or fertilization of an egg. Some research suggests Plan B also may keep a fertilized egg from attaching to the womb, and some opponents considered that mechanism equal to an abortion.

Plan B is different from RU-486, a pill that causes an abortion early in pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus. RU-486 also is known as Mifeprex or mifepristone.

Shares of Barr, which is based in Woodcliff Lake, New Jersey, rose $1.03, or 1.8 percent, to $59 in morning New York Stock Exchange trade.

(Additional reporting by Susan Heavey)

Well, Hallelujah! The Christian right is strong, but the pharmaceutical lobby is stronger. Which is favorable in this instance.

That is pretty convenient. :blob2:

Oh, good. I ****ed like ten guys the other night at the Def Leppard/Journey concert out on the lawn, and I'd left the condoms out in the truck. Then again, I only had eight of them so I guess it wouldn't have mattered anyways.

I was gonna douche with coca-cola, I read in one of those awesome emails that I get forwarded that it works like a charm. But now this makes it way easier for next time.

That was you :eek: I had a great time :wavey: :p

Which one were you? If you were the one with the Billy Squier t-shirt who kept repeating lines from "The Stroke" while we were rolling around, there is no way I'm calling YOU back.

Well, there was no way you were gonna simmer down :cool:

this is good news!

So that was you...
 

couldnt recognize ya from the back :lol:

I agree, but...um...you won't really ever need this. :laugh: I think it's funny that people presume that it would only be needed in the event that someone was promiscuous or stupid. I mean, I'm sure married people who don't want kids right now, and people who just sleep with one person, and all kinds of non slutty people use it. Not that I approve of the term "slut" to describe anyone, what people do is their own business, and who they sleep with doesn't affect me. And god bless anyone who chooses not to have a child when they shouldn't, or don't want to. Any population growth reduction is A-okay in my book.

hee. yeah, you're right about that. but y'know ... i could get really drunk one night and ...

ok, still probably not. :laugh:

i agree. i'm sure there is a huge non-"slut" market out there for this drug.

I dont know about any of youse guys, but I was very surprised this passed! Bushwhacker has filled all the key positions with anti-choice people so there musta been some MAJOR pull from the more liberal sector somehow...

'course, I know the pill companies like this idea but they arent going to be selling all THAT many pills compared to heartburn medicine or depression medicine or something like that...this isnt going to be a real huge money maker for them so Im just surprised all around that it passed. Anyway, its a HUGE victory for women's rights issues (autonomy and all that) so, that MY big thing.

I swear that threw me right to the floor!!!:lol: :lol:

Just stay away from Mentos. your junk will explode!:laugh:

INteresting visual there....:lol:

Great news for our clinic. I can't tell you how much time we waste on people wanting the MAP, when other (sick, injured) kids could be seen instead in that appointment slot.

In general, most people use it once in a while, they usually say the condom breaks. I must say, I've never had a condom break during sex, so they must be doing something wrong with it if it happens often. :rolleyes: A few women come in pretty frequently, which is probably not the best thing. But in reality, studies have not shown any physical complications from using it too often. I personally wouldn't want to keep ingesting large amounts of hormones, but hey - it's their body. :shrug:

I don't understand- why not just use birth control in the first place? :shrug:

1) rape
2) accidents happen
3) birth control isn't 100% effective

I'm not talking about rape- I'm talking about using it as a form of birth control. I was raped and was given the morning after pill- it's not pleasant.

Birth control IS like 99.9% effective if taken correctly.

So if you're on the pill the accidents happen and rape excused don't fly.

I was wondering the same thing...why not just take the pill in the first place? But whatever.

This will not come without a fight -many groups are already looking to fight this.

Of course Planned Parenthood is also fighting - to get unlimited access. I gotta say - are they EVER happy. I'm sorry but as much as I believe in choice I don't think this should be readily available to minors.

It's been available to rape victims for years. I completely agree with everything you've said. We have the choice to prevent pregnancy BEFORE we have sex. Maybe it will help in cases of incest, etc but I doubt it because a girl who gets pregnant by a relative is probably not going to get to the doctor the day after.

Edit: I am totally pro-choice- I just think that women should be more responsible in PREVENTING pregnancy.

oh. well, you didn't clarify. the effects of the pill aren't pleasant? maybe so, but i guess that's the person's choice.

BC pill or no BC pill, if i were raped, i would want to take the morning after pill anyway. BC pills can have bad effects on people - it is not a solution for everyone. condoms break, etc (and this is what i was talking about when i said "accidents happen." not, oops, i had unprotected sex!). either way, i don't care whether people take preventative measures or not - it's not my body. also, there is a difference between 100% and 99.9%.

EDIT: i should qualify my statement about not caring whether people take preventative measures or not. i think almost everyone should use some form of BC. people need to stop having babies in general. but i guess when it comes down to it, i don't care if people stop a pregnancy the night before or the morning after, just as long as it happens.

Right - now I don't mean to imply that all women should take the pill in case they get raped - I hope it didn't come across that way.

I just heard thought that even kids under age 17 can't get this pill AT ALL...parents or not - that I do not agree with because of cases of incest and rape.

Another stitch in this whole thing is the MAP will be behind pharmacy counters - and pharmacists can refuse to sell it based on moral reasons - which is not cool in my opinion.

Anyway - I agree, I wish more women would be more proactive in preventing pregnancy - it's really pretty easy to NOT get pregnant.

according to planned parenthood:

i agree about that. it's pretty easy. the problem is, there are a lot of stupid people out there ... i'm just glad there's another way to stop them from procreating. :laugh:

It ISNT readily available to minors. Only adult Women have the ability to buy this w/o an RX. Minors still have to get an RX, and parents usually know about this. I agree with Planned Parenthood however that there ARE cases in which the parents knowing would be devastating for the minor and that in those cases, it should be available IMO. I know from the research Ive done that often times, these minors are either the victims of incest or their family dynamics are such that if they disclosed their pregnancy to their family, they'd be out on the street. Sad but true. Teen pregnancies have decreased but they havent gone away altogether and with the current evangelical fervor gripping the country, Im inclined to let these poor gals get the pill. The alternative (having a baby they're ill-equipped to raise) is even worse IMO.

Most women ARE~! but again, you can get pregnant on any birth control method. Some women are extremely fertile no matter what method they use :shrug: my mother and my sister and even myself all got pregnant on the pill.

Here in Oklahoma...
 

U.S. Senator Tom "Dr.Death" Coburn (R-tard from Muskogee, Gee how could such an asshole come from my hometown) is equating that availibility of this drug being over-the-counter, will be as if a woman could walk into a convienence store & purchase a 6 six pack of alcohol.

The local OKC news has stated that pharmacists in Oklahoma do not have to fill the prescription for the morning after pill, if they feel it is against their moral beliefs. Yet another dumb law on the Oklahoma books...Gee, isnt it any wonder that Oklahoma is constantly #1 of the United States in teen pregnancy.

Wal-Mart & CVS pharmacies have yet to decide if they will carry the pill, Walgreens does carry it, but again it is at the discretion of the pharmacist to determine if the prescription will be filled.



Trivial question: What is the most "Conservative city" in the US? Hint, the city has the letters O-K-C in its name.

Well evidently they can't keep the sperm outta their bodies, so what's a few hormones, right ?:wavey:

I know a lot of girls who don't want to take birth control regularly, it messes with their body. I'm not one of those girls, luckily, but if I was I wouldn't want to take the pill either.

So, if they have an accident, the morning after pill is great. It would be awesome if everyone was 100% responsible all the time, but that just isn't the case. Also, there are people who maybe have unexpected sexual encounters a few times a year or something. So, again, in case of accidents, this is ideal for them.

I really don't get what the judgment is about, honestly. Take birth control before, or after, so what's the diff? And the m.o.p. doesn't end pregnancy, it prevents the egg from being fertilized, just like regular b.c.p.'s.

So, if women aren't more responsible in preventing pregnancy before they have sex, which they aren't, no matter how much you want them to be - I'd rather they have this than an abortion or unwanted child. You can say all you want what people should do, but the bottom line is that they don't, and I think this is a real boon. Also, again, taking the m.o.p. is taking precautions before pregnancy - it prevents fertilization.

Also, I've taken it and haven't had any averse affects. But, everyone's body is different, which goes great for my argument of why some girls don't like to take the pill regularly.
Also, as an aside, I don't like to morally regulate sexuality. And I think taking the m.a.p. is being proactive. And let me tell you, getting a prescription within 72 hours can be a pain in the a**.
oops, I was writing "mop" instead of "map", which is kind of funny if you think about it.

i was thinking, maybe she's saying 'morning OF pill,' because, y'know... morning sex is nice, too. :laugh:

The preceding was some of the strangest postage I have yet seen in cyberspace. "calf porn" OY.

The morning after pill prevents pregnancy so the girl would not be pregnant but will have had sex. And yes, in some families that cannot be disclosed without sever repercussions. The pill prevents a fertilized egg from embedding itself in the uterus. It is 75% effective.

Jannie - did you take it a while ago? I don't want to be nosy, I'm just curious, because we rarely hear complaints about side effects in our clinic, usually just irreg. periods & some nausea. :shrug: It used to be a much higher dose of hormones, so that's why I ask.

I'm so glad. especially after watching the special about botched abortions on 30 Days this week. while I am all about preventative measures, this is another choice for women to make, which is what pro-choice is all about. it all must be looked at on an individual basis. and yes, the "morning after" pill is not pleasant.

Suze, I was talking about "pregnancy" in the event these teen moms DIDNT have access to the m.a.p. or a clinic. Teens are the biggest group affected by this legislation IMO, because they have no voice really. I cant understand why the far right is so hell-bent on CONTROLLING the rest of the nation, as if we must all march lockstep with THEIR moral code......it makes me sick :mad:

Ah, got ya. It really sucks how much "morality" is pushed onto people. Where is that freedom we are always hearing about?

Well, their argument is the fetus, zygote, etc. is a life from the moment of conception and that life has freedoms which must be protected as well. Interestingly, the Court in Roe agreed with this line of thinking. But, in Roe, the Court held that the state's interest in protecting the life of the unborn outweighs the mother's right to privacy only when the fetus is viable outside of the womb, which the Court after a long discussion found was after the first trimester.

Roe really was a landmark case in many ways, the least of which was expanding a right not specifically found in the Const.

If men got pregnant there would be no such argument and you'd be able to get the morning after pill in the candy aisle. :lol: JK, I would argue that since the fetus is wholly dependent on its mother's body it is up to her to choose.

Is a fertilized egg even a zygote? I don't think it is yet.

no joke I have that as a bumper sticker (If men got pregnant, abortion would be a sacrament)


YES! and there you have it in a nutshell folks, without a host body for the developing fetus to draw from it would be dead. And I can remember a compelling argument by Anne Quinlan that said the rights of the already living outweigh the rights of the not yet born. I happen to agree.

I found this:

btw, Im not biting Jason, we've already gone round and round about whether the Supremes did in fact "create" new law by lumping privacy with other rights.

I still find it amusing (in a sad kind of way) that the Religious Right and Conservatives get all up in arms about a freaking egg and sperm but once a kid is born - it's fend for yourself of die....they don't care about actual people.