Victory for the Ladies (those age 18+)
VictoryGin
Posts: 1,207
The Train opened just in time to celebrate, holla! 
August 24, 2006
Morning After Pill Is Cleared for Wider Sales
By GARDINER HARRIS
WASHINGTON, Aug. 24 The Food and Drug Administration today approved over-the-counter sales of the morning-after contraceptive pill to women 18 and older, resolving one of the most contentious issues in the agencys 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Laboratories, will be sold only in pharmacies and health clinics. To buy it, women will have to show proof of age. Girls under the age of 18 will still need a prescription to get the drug.
Acting F.D.A. Commissioner Andrew C. von Eschenbach said in a memorandum released this morning that he had decided that 18 was the appropriate cut-off age for sales because pharmacies already restrict nicotine and cold medicines that way.
This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older, Dr. Andrew C. von Eschenbach wrote.
Dr. von Eschenbachs predecessor, Dr. Lester M. Crawford, said last year that science supported giving over-the-counter access of the drug to women as young as 17, but that he could not figure out how to ensure that such an age restriction was enforced.
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. A memorandum written by Dr. Steven Galson, director of the F.D.A.s drug center, said that Barr should send to state pharmacy boards any reports that it happens to receive of pharmacists who repeatedly sell Plan B to minors. Barr has agreed not to sell the pills at gas stations or convenience stores, to ensure better compliance with the rules.
Anti-abortion groups strongly opposed Barrs application to switch Plan B from prescription to over-the-counter status, saying that the medicine is an abortion pill whose widespread availability could lead to an increase in sexually transmitted diseases.
Abortion rights advocates pushed equally hard to get the application approved, contending that easy access to Plan B would sharply reduce the nearly 1 million abortions performed each year in the United States.
Both sides are wrong, studies suggest. Couples in the United States have so much unprotected sex half of all pregnancies are unplanned that even if the pills were passed out like lollipops, they would be unlikely to cause a major change in abortion and disease rates.
Emergency contraceptives dont work if, like condoms, theyre left in the drawer, said Dr. James Trussell, director of the office of population research at Princeton University. And studies show that even if women have the pills on hand, the drawer is where they remain.
Indeed, Plan Bs effect on the F.D.A. and its image may well overshadow its public health impact. The agency has been considering the switch for three years, through three different commissioners.
I cannot recall any other issue in my 45 years of watching F.D.A. that has garnered this much attention at all levels of government, said Peter Barton Hutt, a former general counsel for the agency who now teaches drug law at Harvard.
The director of the agencys office of womens health resigned last year to protest what she said was the abortion politics behind the delay in approving Plan B. An investigation by the Government Accountability Office concluded that top agency officials had decided to reject the initial Plan B application months before a scientific review was complete.
Sworn depositions show that some of the agencys science staff members were convinced that no amount of scientific evidence would have persuaded the agencys political appointees to approve the application.
Dr. John Jenkins, director of the agencys office of new drugs, said in a deposition that his boss, Dr. Steven Galson, told him that he felt he didnt have a choice but to reject the application, according to transcripts provided to The New York Times.
And he characterized that in a sense that he wasnt sure that he would be allowed to remain as center director if he didnt agree with the action, Dr. Jenkins said. Dr. Galson, director of the agencys drug center, is Dr. Jenkins boss.
Dr. Florence Houn, director of the office that evaluated the Plan B application, said that she was told by Dr. Janet Woodcock, a deputy F.D.A. commissioner, that a rejection was necessary to appease the administrations constituents, and then later this could be approved.
Drs. Galson and Woodcock both said in their own depositions and public statements that scientific considerations drove their decisions. One memorandum that has since been made public states that Dr. Woodcock told agency employees that she feared that Plan B could take on urban legend status that would lead adolescents to form sex-based cults.
Sen. Hillary Clinton, a Democrat from New York, and Sen. Patty Murray, a Democrat from Washington State, became so concerned about the delays surrounding Plan B that they placed a legislative hold on Dr. Crawfords nomination last year as F.D.A. commissioner.
The senators lifted the hold after Health and Human Services Secretary Michael O. Leavitt promised that the F.D.A. would act on the Plan B application by Sept. 1 of last year. Dr. Crawford was confirmed.
The agency then announced a further delay in the application, something Ms. Murray said in an interview amounted to the worst double-cross Ive ever seen in my time in the Senate. Mr. Leavitt responded that the delay amounted to an action.
When Dr. Crawford unexpectedly resigned weeks later, the senators said that they would not be fooled again. They have held up Dr. von Eschenbachs nomination to become commissioner, saying that this time they want a Plan B decision first.
The agency added to this strange history today when it released several documents supporting its Plan B decision, including an extraordinary 7-page memorandum by Dr. Galson that clarifies some of his earlier statements.
The memo explains why he now agrees with Dr. von Eschenbach that 18 is a better age restriction than 17, and offers a detailed rebuttal of a previously undisclosed suggestion by subordinates that complaints about noncompliant pharmacists be sent to the federal agency instead of state pharmacy boards.
In a press briefing on Monday, President Bush was asked whether he supported Dr. von Eschenbachs intention to approve over-the-counter sales of Plan B a rare moment when a president addressed an application pending before the agecny.
Mr. Bush said that minors should need a prescription to obtain Plan B.
And I support Andys decision, he said.
The Plan B application has also seeped into popular culture. Earlier this month, Plan B was the subject of a passionate argument on the popular TV talk show, The View.
Still, confusion about the medicine is widespread. Many womens health clinics pass out cards explaining the difference between Plan B, a contraceptive, and RU-486, the abortion drug.
Plan B is made from a synthetic hormone found in regular oral contraceptives. It should be taken within 72 hours of unprotected sex, and like The Pill, it generally acts by preventing ovulation or fertilization, according to the agency. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted something abortion opponents decry. But regular oral contraceptives would prevent implantation in the same way.
RU-486, on the other hand, causes a woman to miscarry a well-established pregnancy.
August 24, 2006
Morning After Pill Is Cleared for Wider Sales
By GARDINER HARRIS
WASHINGTON, Aug. 24 The Food and Drug Administration today approved over-the-counter sales of the morning-after contraceptive pill to women 18 and older, resolving one of the most contentious issues in the agencys 100-year history.
The drug, an emergency contraceptive called Plan B that is manufactured by Barr Laboratories, will be sold only in pharmacies and health clinics. To buy it, women will have to show proof of age. Girls under the age of 18 will still need a prescription to get the drug.
Acting F.D.A. Commissioner Andrew C. von Eschenbach said in a memorandum released this morning that he had decided that 18 was the appropriate cut-off age for sales because pharmacies already restrict nicotine and cold medicines that way.
This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older, Dr. Andrew C. von Eschenbach wrote.
Dr. von Eschenbachs predecessor, Dr. Lester M. Crawford, said last year that science supported giving over-the-counter access of the drug to women as young as 17, but that he could not figure out how to ensure that such an age restriction was enforced.
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. A memorandum written by Dr. Steven Galson, director of the F.D.A.s drug center, said that Barr should send to state pharmacy boards any reports that it happens to receive of pharmacists who repeatedly sell Plan B to minors. Barr has agreed not to sell the pills at gas stations or convenience stores, to ensure better compliance with the rules.
Anti-abortion groups strongly opposed Barrs application to switch Plan B from prescription to over-the-counter status, saying that the medicine is an abortion pill whose widespread availability could lead to an increase in sexually transmitted diseases.
Abortion rights advocates pushed equally hard to get the application approved, contending that easy access to Plan B would sharply reduce the nearly 1 million abortions performed each year in the United States.
Both sides are wrong, studies suggest. Couples in the United States have so much unprotected sex half of all pregnancies are unplanned that even if the pills were passed out like lollipops, they would be unlikely to cause a major change in abortion and disease rates.
Emergency contraceptives dont work if, like condoms, theyre left in the drawer, said Dr. James Trussell, director of the office of population research at Princeton University. And studies show that even if women have the pills on hand, the drawer is where they remain.
Indeed, Plan Bs effect on the F.D.A. and its image may well overshadow its public health impact. The agency has been considering the switch for three years, through three different commissioners.
I cannot recall any other issue in my 45 years of watching F.D.A. that has garnered this much attention at all levels of government, said Peter Barton Hutt, a former general counsel for the agency who now teaches drug law at Harvard.
The director of the agencys office of womens health resigned last year to protest what she said was the abortion politics behind the delay in approving Plan B. An investigation by the Government Accountability Office concluded that top agency officials had decided to reject the initial Plan B application months before a scientific review was complete.
Sworn depositions show that some of the agencys science staff members were convinced that no amount of scientific evidence would have persuaded the agencys political appointees to approve the application.
Dr. John Jenkins, director of the agencys office of new drugs, said in a deposition that his boss, Dr. Steven Galson, told him that he felt he didnt have a choice but to reject the application, according to transcripts provided to The New York Times.
And he characterized that in a sense that he wasnt sure that he would be allowed to remain as center director if he didnt agree with the action, Dr. Jenkins said. Dr. Galson, director of the agencys drug center, is Dr. Jenkins boss.
Dr. Florence Houn, director of the office that evaluated the Plan B application, said that she was told by Dr. Janet Woodcock, a deputy F.D.A. commissioner, that a rejection was necessary to appease the administrations constituents, and then later this could be approved.
Drs. Galson and Woodcock both said in their own depositions and public statements that scientific considerations drove their decisions. One memorandum that has since been made public states that Dr. Woodcock told agency employees that she feared that Plan B could take on urban legend status that would lead adolescents to form sex-based cults.
Sen. Hillary Clinton, a Democrat from New York, and Sen. Patty Murray, a Democrat from Washington State, became so concerned about the delays surrounding Plan B that they placed a legislative hold on Dr. Crawfords nomination last year as F.D.A. commissioner.
The senators lifted the hold after Health and Human Services Secretary Michael O. Leavitt promised that the F.D.A. would act on the Plan B application by Sept. 1 of last year. Dr. Crawford was confirmed.
The agency then announced a further delay in the application, something Ms. Murray said in an interview amounted to the worst double-cross Ive ever seen in my time in the Senate. Mr. Leavitt responded that the delay amounted to an action.
When Dr. Crawford unexpectedly resigned weeks later, the senators said that they would not be fooled again. They have held up Dr. von Eschenbachs nomination to become commissioner, saying that this time they want a Plan B decision first.
The agency added to this strange history today when it released several documents supporting its Plan B decision, including an extraordinary 7-page memorandum by Dr. Galson that clarifies some of his earlier statements.
The memo explains why he now agrees with Dr. von Eschenbach that 18 is a better age restriction than 17, and offers a detailed rebuttal of a previously undisclosed suggestion by subordinates that complaints about noncompliant pharmacists be sent to the federal agency instead of state pharmacy boards.
In a press briefing on Monday, President Bush was asked whether he supported Dr. von Eschenbachs intention to approve over-the-counter sales of Plan B a rare moment when a president addressed an application pending before the agecny.
Mr. Bush said that minors should need a prescription to obtain Plan B.
And I support Andys decision, he said.
The Plan B application has also seeped into popular culture. Earlier this month, Plan B was the subject of a passionate argument on the popular TV talk show, The View.
Still, confusion about the medicine is widespread. Many womens health clinics pass out cards explaining the difference between Plan B, a contraceptive, and RU-486, the abortion drug.
Plan B is made from a synthetic hormone found in regular oral contraceptives. It should be taken within 72 hours of unprotected sex, and like The Pill, it generally acts by preventing ovulation or fertilization, according to the agency. Plan B may in rare circumstances prevent a fertilized egg from becoming implanted something abortion opponents decry. But regular oral contraceptives would prevent implantation in the same way.
RU-486, on the other hand, causes a woman to miscarry a well-established pregnancy.
if you wanna be a friend of mine
cross the river to the eastside
cross the river to the eastside
Post edited by Unknown User on
0
Comments
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This is good enough news to actually warrant two threads, if you ask me
"Nothing in the world is more dangerous than sincere ignorance and conscientious stupidity." ~ MLK, 19630 -
In related news, Illinois governor Rod Blaegowrimojowieicvich has mandated that all pharmacies in the state prominently display signs informing women of their legal rights concerning birth control, specifically Plan B.
Holla, indeed."Of course it hurts. You're getting fucked by an elephant."0 -
hippiemom wrote:This is good enough news to actually warrant two threads, if you ask me
Absolutely! It's about time this happened. (And at least it's not two super-hateful threads or anything else of late). if you wanna be a friend of mine
cross the river to the eastside0 -
i agree. Pretty soon, if we can keep the momentum we seem to have going, women will not have to make ANY responsible decisions or choices regarding sex. woooooo hoooooo!"When all your friends and sedatives mean well but make it worse... better find yourself a place to level out."0
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cornnifer wrote:i agree. Pretty soon, if we can keep the momentum we seem to have going, women will not have to make ANY responsible decisions or choices regarding sex. woooooo hoooooo!
That didn't take long... if this momentum continues, women will have more and more options regarding birth control. How is that a bad thing?"Of course it hurts. You're getting fucked by an elephant."0 -
I'm all for this as long as abortion is never viewed as birth control. To me this announcement is pretty much a who cares but if some people want to celebrate it then so be it.Milhouse VanHouten wrote:That didn't take long... if this momentum continues, women will have more and more options regarding birth control. How is that a bad thing?“One good thing about music,
when it hits you, you feel to pain.
So brutalize me with music.”
~ Bob Marley0 -
cornnifer wrote:i agree. Pretty soon, if we can keep the momentum we seem to have going, women will not have to make ANY responsible decisions or choices regarding sex. woooooo hoooooo!
I would consider seeking out Plan B to be a responsible decision.if you wanna be a friend of mine
cross the river to the eastside0 -
surferdude wrote:I'm all for this as long as abortion is never viewed as birth control. To me this announcement is pretty much a who cares but if some people want to celebrate it then so be it.
It's definitely a big deal to a lot of people, especially after all the politically motivated nonsense that held up the FDA approval."Of course it hurts. You're getting fucked by an elephant."0 -
Just a side question: is that the govenor's real name....if so, I hated to be him in grade school!Milhouse VanHouten wrote:In related news, Illinois governor Rod Blaegowrimojowieicvich has mandated that all pharmacies in the state prominently display signs informing women of their legal rights concerning birth control, specifically Plan B.
Holla, indeed."F**K you, I have laundry to do" -ed0 -
Or the designer of his campaign signs..........yikes.......;)humanlight wrote:Just a side question: is that the govenor's real name....if so, I hated to be him in grade school!All the world will be your enemy, Prince with a thousand enemies, and whenever they catch you, they will kill you. But first they must catch you, digger, listener, runner, prince with the swift warning. Be cunning and full of tricks and your people shall never be destroyed.0 -
Milhouse VanHouten wrote:That didn't take long... if this momentum continues, women will have more and more options regarding birth control. How is that a bad thing?
Come on. There are plenty of options. Problem is they all require responsible decision making BEFORE sex. You're right. I can see where thats a problem. Look, i'm grown, married with three children (all boys, no daughters), and have had a vasectomy. This isn't an issue i get my undies in a wad about. Lets be honest, however. This really isn't about choice and options. Its about completely eliminating responsibility along with any consequences of poor choices."When all your friends and sedatives mean well but make it worse... better find yourself a place to level out."0 -
To play with that argument, then, wouldn't that be one step closer to women joining men and creating a more level playing field regarding sex?cornnifer wrote:i agree. Pretty soon, if we can keep the momentum we seem to have going, women will not have to make ANY responsible decisions or choices regarding sex. woooooo hoooooo!0 -
cornnifer wrote:Come on. There are plenty of options. Problem is they all require responsible decision making BEFORE sex. You're right. I can see where thats a problem. Look, i'm grown, married with three children (all boys, no daughters), and have had a vasectomy. This isn't an issue i get my undies in a wad about. Lets be honest, however. This really isn't about choice and options. Its about completely eliminating responsibility along with any consequences of poor choices.
Tell me what choice a young lady who was raped had before this was legal?
Abortion or Have the baby....this way she simply takes a pill to not get pregnant!"F**K you, I have laundry to do" -ed0 -
RainDog wrote:To play with that argument, then, wouldn't that be one step closer to women joining men and creating a more level playing field regarding sex?
ummmm, ... no."When all your friends and sedatives mean well but make it worse... better find yourself a place to level out."0 -
cornnifer wrote:Come on. There are plenty of options. Problem is they all require responsible decision making BEFORE sex. You're right. I can see where thats a problem. Look, i'm grown, married with three children (all boys, no daughters), and have had a vasectomy. This isn't an issue i get my undies in a wad about. Lets be honest, however. This really isn't about choice and options. Its about completely eliminating responsibility along with any consequences of poor choices.
Plan B won't be used as a substitute for other birth control regimens. Do you think that women are going to hoard Plan B, have unprotected sex, and then take the pill the next morning? That seems pretty ridiculous to me. I'd describe it as more of a backup plan... a PLAN B, if you will, that can be used if a mistake is made or something unforseen happens... like a rape, for example.
EDIT: Of course, if you're 18 or over, you can buy it over the counter and use it any way you damn well please... but that's the whole point of the thread, isn't it?"Of course it hurts. You're getting fucked by an elephant."0 -
humanlight wrote:Tell me what choice a young lady who was raped had before this was legal?
Abortion or Have the baby....this way she simply takes a pill to not get pregnant!
You're absolutely right, because, i'm sure that's exactly why this pill needs to be so easily accessible. For all those rape victims. i'm sure thats EXACTLY who will be using this drug the most. i'm sure every woman alive is rushing to the store, even as we speak, to pick up a bottle of these just in case they are raped this weekend."When all your friends and sedatives mean well but make it worse... better find yourself a place to level out."0 -
they should rename this pill the "no more pulling out pill"
this is a victory for men as well in my opinion
0 -
HM or VG, Do either of you know the success rate of the 'Plan B' pill working? If it is high should this now do away with the idea of child support resulting from one night stands? In that the woman had options after the fact to avoid pregnancy but chose not to take them.“One good thing about music,
when it hits you, you feel to pain.
So brutalize me with music.”
~ Bob Marley0 -
Really? Cool.cornnifer wrote:ummmm, ... no.
So, what's the beef, here? You talk about responsibility regarding sex, yet only mention women. So, either they're going to join men in their irresponsibility - that sexual resoponsibility was always the sole domain of women - or men and women were already on a level playing field and now women can be more irresponsible than men.0
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