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View Full Version : Morning-after pill to be available without prescription


Infiniti2001
Aug 24th, 2006, 01:49 PM
Buyers must prove they're 18 or older

Thursday, August 24, 2006; Posted: 9:39 a.m. EDT (13:39 GMT)

http://i.a.cnn.net/cnn/2006/HEALTH/08/24/morning.after.pill.ap/story.pill.gi.jpg
Plan B will be available over the counter to women 18 or older.

WASHINGTON (AP) -- Women may buy the morning-after pill without a prescription -- but only with proof they're 18 or older, federal health officials ruled Thursday, capping a contentious 3-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the pills, called Plan B, the Food and Drug Administration told manufacturer Barr Pharmaceuticals Inc.

The compromise decision is a partial victory for women's advocacy and medical groups that say eliminating sales restrictions could cut in half the nation's 3 million annual unplanned pregnancies.

The pills are a concentrated dose of the same drug found in many regular birth-control pills.

When a woman takes the pills within 72 hours of unprotected sex, they can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

Barr has said it hopes to begin nonprescription sales of Plan B by the end of the year.

The pills will be sold only from behind the counter at pharmacies -- so the pharmacist can check photo identification -- but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, Dr. Andrew von Eschenbach, the FDA's acting commissioner, said in a memo obtained by The Associated Press.

But Barr did prove that over-the-counter use is safe for older teens and adults -- and licensed pharmacies are used to checking for proof of age 18 before selling tobacco and certain other products, von Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction and pledged to continue trying to get the agency to try to eliminate it.

"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," said Bruce L. Downey, Barr's chairman.

As a condition of approval, Barr agreed to track whether pharmacists are enforcing the age restriction, by, among other things, sending anonymous shoppers to buy Plan B.

The FDA said that Barr is to conduct that formal tracking at least twice in the first year of sales and annually thereafter, and report stores that break the rules to their state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise awareness of emergency contraception, among both women and health providers.

http://www.cnn.com/2006/HEALTH/08/24/morning.after.pill.ap/index.html

Personally I believe this is a good move. Let's hope heffers out there do everything in their power to avoid abusing the service :tape:

decemberlove
Aug 25th, 2006, 06:33 AM
Finally.

pla
Aug 25th, 2006, 09:13 AM
So the 18 and older can be safe in a case of an accident but the U18 have to get pregnant :lol:

Anyways, it's a good decision. It has to be started from somewhere :yeah:

saki
Aug 25th, 2006, 09:27 AM
Works fine in the U.K. Been no problems with it. (It's very expensive, though, so if I ever need it, I'll go and get a prescription.)

Infiniti2001
Aug 25th, 2006, 12:58 PM
Works fine in the U.K. Been no problems with it. (It's very expensive, though, so if I ever need it, I'll go and get a prescription.)

It sure is expensive, but you can get it a little cheaper at Planned Parenthood here in the U.S. :shrug:

Wigglytuff
Aug 25th, 2006, 02:06 PM
it a shame that it too this long fore the fda to see rape victims as human but a small step forward is still a step forward

veryborednow
Aug 25th, 2006, 02:43 PM
Works fine in the U.K. Been no problems with it. (It's very expensive, though, so if I ever need it, I'll go and get a prescription.)
Unless I was extremely underage and couldn't get a doctors appointment without my parents knowing I've never heard of a doctor saying no, so can't see the point in buying it straight over the counter.

Ferosh
Aug 25th, 2006, 02:53 PM
I can hear Elizabitch Hasselbeck now.

Helen Lawson
Aug 25th, 2006, 02:57 PM
A drunk wakes up next to a dead body and tries to figure out why with a stranger.

Martian KC
Aug 25th, 2006, 03:03 PM
I can hear Elizabitch Hasselbeck now.

Oh Lord!:lol:

Infiniti2001
Aug 25th, 2006, 03:14 PM
I can hear Elizabitch Hasselbeck now.

Thank God the View is on hiatus now :lol:

Hannah-Louise
Aug 25th, 2006, 10:38 PM
yea my friend told me the other day that here in Boots (very famous highstreet pharmacy) if u are under 18 but can prove ur 16 or over then u can have it free rather than like £25. or see ur GP for it free!

Blonde_Ambition7
Aug 25th, 2006, 10:58 PM
I'm not sure how I feel about this yet.
I hope it's not abused.

Reuchlin
Aug 25th, 2006, 11:17 PM
There was a program here on the CBC which ran an editorial about plan B. It was some of the most one sided journalism I have ever SEEN. They kept harping on the fact that Christian Fundamentalists wanted to stop plan B from becoming over the counter because they thought it would lead to more casual sex outside of marriage. NOT ONCE WAS THE REAL OBJECTION TO THE PILL MENTIONED: If sperm has already fertl. the egg than the pill causes AN ABORTION. This is what is most troubling about the pill.
Now, whether you are pro-life or pro-choice I think you WOULD want to see women making informed descisions about their reproductive choices that are in line with their values. That is why it is unfortunate that the true 'science' of the pill is not talked about widely.

veryborednow
Aug 25th, 2006, 11:18 PM
I'm not sure how I feel about this yet.
I hope it's not abused.
How does one abuse the morning after pill?

Only incredibly rich people could rely on it as a regular contraceptive, s'pose that's why they keep the price up there.

H-L yeah I thought it was free too, but I deleted that post cos I wasn't sure. Can't see the reason not to go to the GP even more now.

Wigglytuff
Aug 25th, 2006, 11:23 PM
There was a program here on the CBC which ran an editorial about plan B. It was some of the most one sided journalism I have ever SEEN. They kept harping on the fact that Christian Fundamentalists wanted to stop plan B from becoming over the counter because they thought it would lead to more casual sex outside of marriage. NOT ONCE WAS THE REAL OBJECTION TO THE PILL MENTIONED: If sperm has already fertl. the egg than the pill causes AN ABORTION. This is what is most troubling about the pill.
Now, whether you are pro-life or pro-choice I think you WOULD want to see women making informed descisions about their reproductive choices that are in line with their values. That is why it is unfortunate that the true 'science' of the pill is not talked about widely.
:lol: :lol: :smash:

Blonde_Ambition7
Aug 25th, 2006, 11:31 PM
How expensive is it?

Infiniti2001
Aug 25th, 2006, 11:38 PM
There was a program here on the CBC which ran an editorial about plan B. It was some of the most one sided journalism I have ever SEEN. They kept harping on the fact that Christian Fundamentalists wanted to stop plan B from becoming over the counter because they thought it would lead to more casual sex outside of marriage. NOT ONCE WAS THE REAL OBJECTION TO THE PILL MENTIONED: If sperm has already fertl. the egg than the pill causes AN ABORTION. This is what is most troubling about the pill.
Now, whether you are pro-life or pro-choice I think you WOULD want to see women making informed descisions about their reproductive choices that are in line with their values. That is why it is unfortunate that the true 'science' of the pill is not talked about widely.

Uh it has been talked about, but Christian fundermentalist are not listening... There's a difference between Plan B and the abortion pill. Plan B prevents pregnancy if taken as soon as possible within 72 hours of sex-- it won't help if a woman is already pregnant. Now the abortion pill is another story :tape:

Infiniti2001
Aug 25th, 2006, 11:40 PM
How expensive is it?

I got 2 for 20 bucks at Planned Parenthood one time. Dunno about pharmacies :shrug:

Reuchlin
Aug 25th, 2006, 11:46 PM
Uh it has been talked about, but Christian fundermentalist are not listening... There's a difference between Plan B and the abortion pill. Plan B prevents pregnancy if taken as soon as possible within 72 hours of sex-- it won't help if a woman is already pregnant. Now the abortion pill is another story :tape:

Plan B prevents a fertilized embryo from implanting itself in the uterus. This can be problematical for those who believe that life begins at conception.

Infiniti2001
Aug 25th, 2006, 11:56 PM
Plan B prevents a fertilized embryo from implanting itself in the uterus. This can be problematical for those who believe that life begins at conception.

Then they shouldn't worry about taking it --instead they need to mind their GODDAMN business :rolleyes: Another thing, if the fertilized egg is already implanted, Plan B won't work.

Reuchlin
Aug 26th, 2006, 12:01 AM
Then they shouldn't worry about taking it --instead they need to mind their GODDAMN business :rolleyes: Another thing, if the fertilized egg is already implanted, Plan B won't work.
very mature response. :o :o :o

Reuchlin
Aug 26th, 2006, 12:02 AM
Then they shouldn't worry about taking it --instead they need to mind their GODDAMN business :rolleyes: Another thing, if the fertilized egg is already implanted, Plan B won't work.

Ok, but you are missing the point: conception has occured already. And some people are protesting (something they have a right to do) the pill becoming over the counter for a number of reaons the most important is people using it without knowing how it works.

Infiniti2001
Aug 26th, 2006, 12:04 AM
very mature response. :o :o :o

Oh well-- I'm just sick of people trying to regulate other peoples' sex lives :rolleyes: I mean, why can't they just live by whatever principles they want to and live others alone?? They just have no right to make anyone else live by them :shrug:

Reuchlin
Aug 26th, 2006, 12:07 AM
Oh well-- I'm just sick of people trying to regulate other peoples' sex lives :rolleyes: I mean, why can't they just live by whatever principles they want to and live others alone?? They just have no right to make anyone else live by them :shrug:

I'll make one comment and that is it (don't want to get into a whole debate). The point is that we are not only talking about people and their sex lives (for all I care you can have sex with as many adults whenever you want). However, when we are talking about what some people believe causes the END of another person's life it is no longer a part of "personal morality"-- as general murder, rape etc. are not. And I am sure you have no problem when the government "regulates" those.

Infiniti2001
Aug 26th, 2006, 12:09 AM
Ok, but you are missing the point: conception has occured already. And some people are protesting (something they have a right to do) the pill becoming over the counter for a number of reaons the most important is people using it without knowing how it works.

I am not missing anything--- the pill should be taken to prevent pregnancy. If one is pregnant, she has no business taking it :help:

pla
Aug 26th, 2006, 12:16 AM
I'm not sure how I feel about this yet.
I hope it's not abused.

If it is, it's none of your, mine or anyone's business, right? ;)

Diam's
Aug 26th, 2006, 12:17 AM
It's free here without prescription/parental authorization for girls 18 and younger.

Chris 84
Aug 26th, 2006, 12:21 AM
It's free here without prescription/parental authorization for girls 18 and younger.

And that's the way it should be everywhere :)

pla
Aug 26th, 2006, 12:22 AM
And that's the way it should be everywhere :)

Amen :devil: ;)

hablo
Aug 26th, 2006, 01:03 AM
Uh it has been talked about, but Christian fundermentalist are not listening... There's a difference between Plan B and the abortion pill. Plan B prevents pregnancy if taken as soon as possible within 72 hours of sex-- it won't help if a woman is already pregnant. Now the abortion pill is another story :tape:
I guess you must have missed the threads about abortion, or you would know about this poster and his views :hug::p:tape:

Blonde_Ambition7
Aug 26th, 2006, 01:17 AM
If it is, it's none of your, mine or anyone's business, right? ;)

No, it isn't really. But I tend to care about what goes on in society. But whatever, people can do what they want.

I don't even really understand how this pill works. So you take it to prevent pregnancy..not to end one?

Reuchlin
Aug 26th, 2006, 01:48 AM
No, it isn't really. But I tend to care about what goes on in society. But whatever, people can do what they want.

I don't even really understand how this pill works. So you take it to prevent pregnancy..not to end one?

the pill prevents a post-conception embryo from implanting in the uterus.

Infiniti2001
Aug 26th, 2006, 02:31 AM
I guess you must have missed the threads about abortion, or you would know about this poster and his views :hug::p:tape:

Now I know :lol: :help:

Wigglytuff
Aug 26th, 2006, 02:37 AM
the pill prevents a post-conception embryo from implanting in the uterus.
nutter.

see thats why you people have no credibility, you worry more about a clump of cell than you do about the living. seriously how many children have you adopted??

Blonde_Ambition7
Aug 26th, 2006, 02:48 AM
the pill prevents a post-conception embryo from implanting in the uterus.

Huh?

Infiniti2001
Aug 26th, 2006, 02:57 AM
No, it isn't really. But I tend to care about what goes on in society. But whatever, people can do what they want.

I don't even really understand how this pill works. So you take it to prevent pregnancy..not to end one?

1. What is emergency contraception?

Emergency contraception is a method of preventing pregnancy to be used after a contraceptive fails or after unprotected sex. It is not for routine use. Drugs used for this purpose are called emergency contraceptive pills, post-coital pills, or morning after pills. Emergency contraceptives contain the hormones estrogen and progestin (levonorgestrel), either separately or in combination. FDA has approved two products for prescription use for emergency contraception Ė Preven (approved in 1998) and Plan B (approved in 1999).

2. What is Plan B?

Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce a womanís risk of pregnancy when taken as directed if she has had unprotected sex. Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription

3. How does Plan B work?

Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

4. What steps did FDA take in considering switching Plan B from prescription to nonprescription (over-the-counter (OTC)) status?

FDA received an application to switch Plan B from prescription to nonprescription status. FDA staff reviewed the scientific data contained in the application which included among other data, an actual use study and a label comprehension study.

On December 16, 2003, we held a public advisory committee meeting with a panel of medical and scientific experts from outside the federal government. The members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. Although the joint committee recommended to FDA that this product be sold without a prescription, some members of the committee, including the Chair, raised questions concerning whether the actual use data were generalizable to the overall population of nonprescription users, chiefly because of inadequate sampling of younger age groups.

Following the advisory committee meeting, FDA requested additional information from the sponsor pertaining to adolescent use. The sponsor submitted this additional information to FDA in support of their pending application to change Plan B from a prescription to an over-the-counter product. This additional information was extensive enough to qualify as a major amendment to the NDA. Under the terms of the Prescription Drug User Fee Act (PDUFA) performance goals, major amendments such as this may trigger a 90-day extension of the original PDUFA deadline.

Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable.

5. Why didnít FDA follow the recommendation of the Advisory Committees?

The recommendations of FDA advisory committees are advisory in nature and the Agency is not bound to follow their recommendations. FDA makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

6. Why did FDA issue a Not Approvable letter?

The agency issued a Not Approvable letter because the supplemental application did not meet the criteria for approval in that it did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner. The issuance of a Not Approvable letter does not mean that a supplemental application cannot be approved. The Not Approvable letter describes what the applicant would need to do to obtain approval for the supplemental application. In this case, the applicant would have to either provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug or provide additional support for the revised indication to allow for marketing Plan B as prescription-only for women under the age of 16 and as nonprescription for women 16 years of age and older. Not Approvable Letter.

7. Was there a difference of opinion within the Center for Drug Evaluation (CDER) and Research regarding the final decision?

Yes, there was a difference of opinion within CDER. The scientific interchange of ideas is widely encouraged during the review process to ensure a thorough vetting of the issues. However, ultimately, a final decision must be made based on the evaluation of the data, taking into account all of the views expressed.

8. Is this FDAís final decision regarding the availability of Plan B for OTC use?

No. The Not Approvable letter to the sponsor outlines what the sponsor must do to obtain approval of the supplemental application.

Wide availability of safe and effective contraceptives is important to public health. We look forward to working with the sponsor if they decide to pursue making this product available without a prescription.

9. Oral contraceptives have been used for four decades, and this product has been approved and used safely since 1999. How could FDA turn it down?

Oral contraceptives as a class of drugs are only available by prescription. This product has been used safely by prescription only and for the reasons already stated, it is not being made available for OTC use at this time.

10. The sponsor has talked about making the product over-the-counter for young women over a certain age and behind-the-counter for younger girls. Is there evidence to support such a scheme? Does FDA have the authority to carry it out?

The sponsor has submitted a plan and the FDA is examining its regulatory authority to approve a product marketed in this manner.

11. Did the FDA bow to political pressure in making this decision?

No. This decision was made within the Center for Drug Evaluation and Research.

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?

No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm

Hannah-Louise
Aug 29th, 2006, 03:06 PM
yea found out...it definately isnt free in Boots-1st hand experience how ironic i read this thread then a few days later im needing it!

Kart
Aug 29th, 2006, 05:03 PM
Wise move.