Morning-after Pill Decision Put On Hold

Discussion in 'Et Cetera, Et Cetera' started by Dr. Dilznick, Aug 27, 2005.

  1. Dr. Dilznick

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    FDA Again Delays Decision
    On 'Morning After' Pill
    Regulators Express Concern
    About Teenagers' Access to Plan B

    By JENNIFER CORBETT DOOREN
    DOW JONES NEWSWIRES
    August 26, 2005 6:56 p.m.

    WASHINGTON -- The Food and Drug Administration again delayed a decision Friday on whether to allow a "morning after" contraceptive pill to be sold without a prescription, saying it still hadn't figured out how to keep younger women from improperly obtaining the product.

    Barr Pharmaceuticals Inc. is seeking FDA permission to sell its morning-after pill, called Plan B, to women ages 16 and older on an over-the-counter basis.

    FDA Commissioner Lester M. Crawford said the agency needs to decide whether the same drug can exist as both a prescription and over-the-counter product and wanted to open up that discussion to the public for the next 60 days.

    During a rare press conference at the FDA's headquarters in Rockville, Md., Mr. Crawford said FDA staff has concluded that the drug could safely be sold to women 17 and older without a prescription. Barr's application asked for permission to sell to women ages 16 and older.

    Mr. Crawford said, however, the FDA won't make a decision until after it deals with the broader regulatory issue of whether the same drug can be sold both over the counter and as a prescription. He wouldn't set a timeline for making a final decision on Barr's application. It also is unclear if Barr will need to submit another application to suggest the drug be sold to those ages 17 and older, rather than its current proposal of age 16.

    Mr. Crawford said the FDA has never allowed the same drug to be sold both over the counter and by prescription with the same indication. He said the agency was uncertain how to keep the pill away from younger women and needed to set up some type of enforcement mechanism with pharmacies.

    "We cannot have this slippage between age groups," he said.

    Barr Disappointed

    Barr Pharmaceuticals said it was disappointed in the FDA's decision not to approve the application to sell Plan B on an over-the-counter basis to women ages 16 and older. The company had proposed having pharmacists "card" women and require them to show a photo ID such as a driver's license.

    "In our submission to the FDA, we provided a detailed legal analysis supporting approval of a dual-label product and continue to believe that a dual-label status can and should be approved for Plan B," said Bruce L. Downey, Barr's chief executive. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product."

    Plan B was approved as a prescription "emergency" contraceptive in 1999. It is made of the hormone progestin, and is designed to prevent pregnancy if taken within 72 hours of unprotected sexual intercourse. Women take two pills 12 hours apart. The pills are similar to birth-control pills but contain higher doses of progestin which blocks a fertilized egg from becoming implanted in a woman's uterus. A handful of states currently allow Plan B to be sold over the counter.

    Barr said Plan B will continue to remain on the market as a prescription drug product while the FDA continues to debate whether and how to allow the drug to be sold over the counter.

    Closely Watched Approval Process

    In 2004, the FDA denied a similar application by Barr to sell Plan B over the counter. At the time, the FDA went against the recommendation of its outside panel of medical advisors -- which voted to recommend Plan B be sold over the counter -- and ignited a debate about whether the Bush administration stepped in and asked the FDA to block the application by Barr.

    Barr amended its application and gave the FDA additional information. The agency was supposed to rule on the new application in January, but again announced a delay. The delay temporarily set back the Senate confirmation of Crawford to head the FDA this spring and summer.

    However, Mr. Crawford told lawmakers then he would rule on Plan B by Sept. 1 and a "hold" that had been placed on his nomination by some Democratic Senators was lifted; he was confirmed to head the FDA in July.

    Opponents of making the pill more readily available argue that such access could lead some young teens to have sex, leaving them more vulnerable to sexually transmitted diseases. Supporters of making Plan B available over the counter said the drug would help women prevent unintended pregnancies and reduce the need for abortions, but to make a real difference, women need to be able to get it quickly.

    --The Associated Press contributed to this article.
    How Plan B Works

    Plan B, commonly called the morning-after pill, is a high dose of birth-control pills taken after having unprotected sex. Scientists think the resulting surge of the hormone progestin may interfere with ovulation, or prevent implantation of the embryo in the uterus if ovulation has already taken place.

    Two doses of the Plan B pill must be taken 12 hours apart. If taken within 72 hours of having unprotected sex, the treatment reduces the risk of pregnancy by 89%. The pills don't work if a woman already is pregnant and won't induce abortion, unlike the controversial RU-486 pill.

    Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com
     
  2. Dr Rock

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    who lives in the east 'neath the willow tree? Sex
    I am so fucking sick of these dipshits.
     
  3. madame_zora

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    Yeah, I'm sure that's exactly the thoughts going through a horny teenager's mind. What kind of glue are these imbeciles sniffing?
     
  4. brainzz_n_dong

    brainzz_n_dong New Member

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    Yeah, I'd not lend any credence to the notion that if, in the mind of your average teenager, you remove one more barrier to having unprotected sex that it could somehow lead to them engaging in just that.

    It's funny...if a male or female under the age of 18 is raped or molested in this country, we call them children. But, when it comes to delaying "this needed reproductive option for women", to quote Teddy Kennedy, that 16 year old girl suddenly becomes a "woman". I guess you get an upgrade in status if the subject at hand has been signed off on by liberal activists.
     
  5. warmsunshine

    warmsunshine New Member

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    Huh? First off, what in the hell does one have to do with the other? And by the way, the age of consent is NOT 18 for the majority of the states in this country. AND being able to decide what is right for yourself (ie abortion) is not the same as something involving force or coersion (ie rape / molestation).
     
  6. madame_zora

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    The obvious difference is between being old enough to make a decision (16 for many states) and being protected from a crime, where anyone under 18 IS a minor.I If a rapist or molestor gets an extra zing on his sentence because of that, I'm all for it. You appear to be standing up for molesters' rights? My, you do make "your side" look as ugly as "my side" perceives it to be.
     
  7. KinkGuy

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    Oh, it's just part of the "morality" stampede. Hell, the same people who are prohibiting the sale of this drug are the ones who have tried (and in several states won) the controlled sale and distribution of condoms. Sheesh. Did you know that in about 15 states in (or what's left of) this country, AIDS clinics and public health organizations, nor the state themselves, can distribute free condoms to anyone who asks? The legal age is 18 and requires "parental consent" under that age. Abstinence only education will prevent horny teens from fucking. Right?
     
  8. jay_too

    jay_too New Member

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    *** whine ***

    I was gonna say that! Late outta the starting gate again.

    jay
    :yourock:
     
  9. warmsunshine

    warmsunshine New Member

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    That? INSANELY stupid. Bordering right up there with the Catholic Church saying things like there are holes in condoms that permit the AIDS virus to go through (but mainly in Africa).
     
  10. jonb

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    Interesting you should bring up rape. That's one of the things the morning-after pill's used for.
     
  11. brainzz_n_dong

    brainzz_n_dong New Member

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    You guys never fail to disappoint...

    It figures the usual suspects in this chat forum would miss (or shall I say misinterpret) anything I would try to say if it doesn't "amen" a position you hold. Would any impartial reader really be surprised, no, probably not. Same shit different day.

    Anyway, since so many of you seem to have problems understanding plain points, I shall try again. From the moral point of view (as much as a moral point of view sickens so many of you unfortunately a few of us have them) is it really necessary to make the morning-after pill available to teenagers as young as 16, without a doctor's prescription, where having that option might lead to riskier sexual behavior than they would otherwise engage in?

    Teens are famous for thinking they're indestructible. We've spent years and untold amounts of money trying to get active teens to use condoms that not only help prevent pregnancy but protect against a whole host of STD's. Now, since many teens never think they can get sick or die from something, the mere presence of the morning-after pill and it's (proposed) easy availability might compel them NOT to be as strict about the use of condoms, which will in turn possibly lead to more teens with STD's, not to mention the king of STD's, AIDS.

    Simply turning age 18 doesn't automatically convey maturity upon a young woman or man. However, in our country we've decided (with the exception of the drinking age) that age 18 represents the age of majority, where you gain the full legal rights of an adult. If this pill is going to become available, is it so much to ask that it also be tied to the age of majority? A lot of growing up takes place between ages 16-18. On the other hand, perhaps many of you feel that once a 16 year old girl first gets her driver's license the first trip she should make is to her local Wal-Mart pharmacy to buy the morning-after pill...ahhh...that must be it. That must be the "old enough to make a decision" criteria a certain someone spoke of.

    It's not surprising (but it is sad) to read that the FDA advisory committee in 2003 voted 20-4 to sell the pill to girls of ANY age, as young as 11. It was FDA drug evaluation/research director Steven Galson that rejected the panel's advice in May 2004. He cited a lack of data about whether the drug can be safely used by girls ages 11-15 without a doctor's supervision.

    I've read and re-read the second paragraph of my original post on this subject. On one hand it wasn't me at my most eloquent, but on the other hand I see the point I'm attempting to make, which I expanded on greatly above. That mz and jay-too see it as me supposedly defending molester's rights, IF I so much as gave an inkling of that it was not my intent. The best I'd ever offer anyone in that category is life in prison without parole. Events of this year have highlighted how wacky judges have let monsters go for no good reason and the horrible results to family after unfortunate family. However, knowing how much delight people like mz and her followers take in twisting or reinventing meanings in other people's posts I suspect more of the latter.

    If the Democratic party is going to push and push and push for this drug, well, that is their right. They are pandering to their political base and they're inside their rights to do so. However, if they attempt to get into a game of re-defining the age of "woman" ever lower, in order to match the pandering of the moment, then at what age do you stop? If the FDA advisory panel originally had a working notion of how to make this drug available to children as young as 11, it makes one wonder.
     
  12. GottaBigOne

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    The only advantageous thing I can think of about making it an over-the-counter drug is that young women who are afraid of their parents finding out they got pregnant, or even had sex will be able to take care of it without their parents finding out. As someone without kids, I really don't care if little Shelly Loosepanties wants to keep shit from her parents, but should the government help her do it?
    Is there any other reason for not needing to go to a doctor first?

    Oh and Brainz, don't feel bad if people here misinerpret you, it happens a lot here, people like to jump to conclusions and label everyone who doesn't agree with them a monster. I understood the point you were trying to make and I was about to expound on it, until i get down to your post.
     
  13. madame_zora

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    Shamrock, I don't see where my not sharing your morals means I don't have any, it just means they are different. As far as misinterpreting your intention, all I can say is I've been called out for not saying what I mean, so if you weren't defending molesters, you should have used an example that demonstrated what you DID mean. I doubt your intention was made clear by your post, that is all.

    I don't know much about this drug, so I can't say whether it is a good idea to make it available to anyone without a doctor's care. If it is deemed safe enough for adults, then physicians should be the ones determining at what age it would be safe, not politicians, or us. I don't think anyone's "morals" should be any factor at all. Those are opinions, not facts.
     
  14. Dr Rock

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    who lives in the east 'neath the willow tree? Sex
    until anyone can offer any evidence to suggest that this supposed "riskier sexual behavior" is a direct consequence of birth control pills, and that its hazards do indeed outweigh the KNOWN and PROVEN benefits of making the pill available to teenagers: hell yes. nobody cares what you think about teenagers having sex; we're just sick of anal-retentive dipshits in authority shoving THEIR morals down everyone else's throat.

    I assume you mean HIV. you can't get AIDS from sexual transmission.
     
  15. warmsunshine

    warmsunshine New Member

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    Interesting. You seem to be saying that those people who disagree with you have no morals. How fucking self-righteous is that? I guess superiority complex is necessary if you want to be a right-winger.

    I'm trying to figure out why you think young people need a reason to have sex. People do it anyway for almost any reason. And no amount of restricting condom sales or abstinence-only "education" or morning-after pill restrictions is going to prevent it. I prefer to give people good, quality INFORMATION rather than promoting ignorance.

    No, actually I think that a 16 year old should be able to get an abortion without her parents' permission. I think that hell, a 12 year old should be able to get life-saving medication or surgery without her parents' permission (in the case of those Christian Scientist parents, remember?). Just as you mentioned the drinking exception, I think there needs to be some sort of exception with pregnancy.
     
  16. warmsunshine

    warmsunshine New Member

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    Gottabigone
    Seems to me that the government would be "helping" if they either paid for the pill or hurting her if they denied her the pill in the first place. I think they should stay out of it entirely and make it available to people who need it without letting the religious wingers in on it in the first place.
     
  17. GottaBigOne

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    The fda comes into play because thye make the decision about whether or not it is available without a prescription. Certain drugs shouldn't be.
     
  18. warmsunshine

    warmsunshine New Member

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    The fda comes into play because thye make the decision about whether or not it is available without a prescription. Certain drugs shouldn't be.
    [post=339080]Quoted post[/post]​
    [/b][/quote]

    They may come "into play" but I don't think it qualifies as either "helping" or "hurting". All the FDA is supposed to do is to certify whether it's (the drug) safe or not for people to take. It's clear that it is safe for 16 year olds to take, but the decision is being delayed not due to safety reasons with the drug, but the conservatives and their views on abortion / sex.

    Frankly the head of the FDA should be removed in my opinion. One of the reasons that the Dems dropped their "hold" on the nomination was that he promised to make a clear decision on this matter and he swore to it under oath and then he pops up with this shit. Ridiculous.
     
  19. KinkGuy

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    So,

    We don't educate our youth about "sex" and it's consequences
    We deny access to condoms, nor do we even discuss them
    We limit, restrict and deny access to the morning after pill.

    Everyones "morals" are intact

    Who's going to pay for and care for, all the forced deliveries of unwanted babies?

    Love the fetus, hate the child.
     
  20. KinkGuy

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    On a slightly different note,
    My 80 something mother is and has always been a supporter of sex education and birth control availability for our youth AND is completely anti-abortion.

    Why?

    Because, this old woman's view is "that if we educate our youth and prepare them for the responsibilities of becoming adults and sexual, it will the thereby demystify and remove any stigma regarding birth control, thereby making it commonplace and accepted"

    "Then we won't have the need for abortion as a form of birth control."

    Smart lady.
     
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