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
Holla, indeed.
Absolutely! It's about time this happened. (And at least it's not two super-hateful threads or anything else of late
cross the river to the eastside
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?
when it hits you, you feel to pain.
So brutalize me with music.”
~ Bob Marley
I would consider seeking out Plan B to be a responsible decision.
cross the river to the eastside
It's definitely a big deal to a lot of people, especially after all the politically motivated nonsense that held up the FDA approval.
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!
ummmm, ... no.
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?
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.
this is a victory for men as well in my opinion
when it hits you, you feel to pain.
So brutalize me with music.”
~ Bob Marley
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.
when it hits you, you feel to pain.
So brutalize me with music.”
~ Bob Marley
i didn't say anything about birth control being the sole responsibility of women. A man, obviously will not be taking this pill. He can certainly encourage its use, however. Men can, and will, rely on this just as much as women. It allows them to be irresponsible as well.
Its kind of like how men are the ones to wear condoms, but a woman should insist on it.
I know that...and I know this may be more convient for some women, but for those who are raped...by a stranger, boyfriend, husband, etc. this gives them another option. I know that IF (god forbid) it happened to me, I would want to take the pill.
Now, you are just twisting my words. I feel that I am a very moral person. I do not feel that abortion is okay for birth control. but I also understand there are people in this country that have very different morals than me. I just don't feel like my moral standards should be imposed on others. Let there be 50 choices! I know my morals and I will stand by them. I just don't feel like limiting choices (in any situation) is a better option.
i would as well. i would also, under such circumstances, expect to be able to obtain it from a doctor or some other emergency authorities.
In a perfect society that may be true...hell in a perfect society Plan B would not even be needed. But there are always people who cannot afford to see a doctor. These are also people who probably cannot afford birth control. I work in very very rural KY, and most of the adults I see have not been to a doctor in years b/c they cannot afford it.
Here is another scenerio where Plan B is a good thing:
A commited couple is have sex and using condoms at thier form of protection. the condom breaks! they were being responsible, but something happened. does that constitue a doctor's visit. Like someone else said on here. the pill is called Plan B, meaing (oh crap...something happened that we did not expect).
How Well Emergency Contraception Works
Progestin-only EC reduces the risk of pregnancy by 89 percent if started within 72 hours of unprotected intercourse. For example, eight out of 100 women will become pregnant after having unprotected sex once during the second or third week of their cycles. But only one woman out of 100 will become pregnant after taking progestin-only EC.
Combination EC reduces the risk of pregnancy by 75 percent if started within 72 hours of unprotected intercourse. Only two out of 100 will become pregnant after taking combination EC.
Emergency contraception is meant as backup birth control only. EC is not as effective as the correct and consistent use of reversible contraception — the IUD, the shot, the pill, the patch, or the ring.
EC does not continue to prevent pregnancy during the rest of the cycle. Other methods of birth control must be used.
Emergency contraception offers no protection against sexually transmitted infections. You may want to consider testing for sexually transmitted infections if there is a possibility that unprotected sex put you at risk.
http://www.plannedparenthood.org/pp2/portal/files/portal/medicalinfo/ec/pub-emergency-contraception.xml#1156433779353::-6418514816611008894
In response to your other questions, I'd say 'no'. The bottom line for me is that women cannot be forced to either be pregnant, or not be pregnant, and they should not be punished for their reproductive choices.
cross the river to the eastside
Seems to me that a lot of people have a problem with women being able to have sex whenever they feel like it.
This is a blessing to rape victims, particularly those unfortunate enough to be taken by ambulance to a Catholic hospital where it never was and probably never will be offered, but of course it isn't only for them. It's for when the condom breaks. It's for when the suitcase with your pills doesn't get to Hawaii until three days after you do. It's for when an unexpected opportunity arises and you don't have your diaphragm with you. It's for when Mr. Cuervo convinces you that something is a good idea, and the next day you realize that it probably wasn't.
Maybe you think a lifetime of unwanted parenthood is a just penalty for a single night of drunken stupidity, but I don't. I don't have a need for this pill anymore, but I sure am glad it's there for my daughters and for every other woman who wants it.