FDA CONSIDERS ALLOWING MORNING AFTER PILL TO BE SOLD OVER THE COUNTER
 

OUTSTANDING!!!

FDA CONSIDERS ALLOWING MORNING AFTER PILL TO BE SOLD OVER THE COUNTER
Its called Plan B. But some have called it the morning after pill. Women who use it within 72 hours after having unprotected sex can lower their risk of pregnancy by almost 90%. Its already available by prescription. But the push to make it available as an over-the-counter drug has faced stiff resistance from many anti-abortion activists, who say Plan B causes abortion. For at least two years, the Food and Drug Administration has put off approving Plan B as an over-the-counter contraception. But today, the FDA said it will now consider allowing those sales to women 18-years-old and up. The FDA maintains its concerned that Plan B might be sold to teens. So, to address that concern, the FDA says the pill will be sold over-the-counterbut behind the counter, much like cigarettes are now. The FDA says that would allow pharmacists to check buyers ages before selling the drug.

I read in the paper this morning that the timing of this announcement is politically motivated to make it more likely for the Dems to allow an FDA appointment through without obstruction.

Either way, it's good news.

decision **first** THIS TIME, possible confirmation to follow. this is the third fda chief in five years. time to stop passing the buck. we'll see if the OTC permission is granted. And then stealth-nullified by a signing statement. :tinfoil:

You have been able to obtain the Morning After Pill without prescription in the UK since 2000. You have to speak to the pharmacist, be over 16 and pay the full price - about £30 from memory. If you go via a GP then you only pay the precription charge of £6.65.

Some areas recently had a free over-the-counter service for under 24 year olds, where you simply gave your details and received your pill from the pharmacist. This gave them the chance to talk to the girl in question about STDs, contraception, chlamydia testing etc. Our PCT had to withdraw this service due to budget restraints, although it is still available out of hours.

I think it's a great idea having this available without having to visit a GP. I took the morning after pill as a teenager and was in a real state trying to get to the Family Planning clinic on time. Yes I had been irresponsible, but at least no-one else had to pay for that in later years.

I have missed my Sundae Girl! Hope you'll be back soon, sweetie!

Evidently the anti-abortionists don't understand how an IUD works. The morning after pill would be no worse and appear to be less intrusive.

Shhhhhh! You want them to hear? For once the complete ignorance of science of the hard core social conservatives is actually working to the advantage of women who want to have some control over their lives.

The morning after pill is available here over the counter. I think this was a great decision for women. Then again, I'm pro choice anyway, so anything that gives a woman more choices is good in my opinion.

This has been used for several years.

Problem with that here in the Bible-belt is that some nut-job pharmacists won't carry it or give it to them for "religious" purposes... also there is the issue of them knowing their parents.
It needs to be over the counter.
I wish I could find some of the articles where I read that insanity.

Is it misunderstood to be an abortifacient like Mifepristone?
It's intended to prevent pregnancy, not terminate it, therefore no different than other contraception.

It does not even necessarily affect fertilised eggs - even the drug company information is speculative:

from http://www.levonelle.co.uk/output/Page7.asp

It's that third one that has some people upset. That would be "post-conception", and therefore not really a "contra-ceptive", no?

I do see what you mean. And having done some background reading on sites that I wouldn't normally visit (SPUC for example) I also see that the medical and moral definitions of both conception and abortion differ, at least in this country.

Which of course brings us back to the IUD, but we're keeping quiet about that (couldn't find a Sshh! emoticon, insert one with your imagination)

I just wonder why it shouldn't be left up to the individual woman to decide. Not every woman taking the morning after pill will have conceived, and of those that have, the "baby" is unwanted and less than 72 hours old. At this stage isn't the life of the mother more important?

Tcha, I'm pro-choice so I don't think I'll ever understand anyway.

Fertilized eggs not attaching: happens all the time. If you were ever trying to have a baby, it probably happened to you and you never knew it.

It is estimated that up to 50% of all fertilized eggs die and are lost (aborted) spontaneously, usually before the woman knows she is pregnant. Among known pregnancies, the rate of spontaneous abortion is approximately 10% and usually occurs between the 7th and 12th weeks of pregnancy.

source: Medline, definition of spontaneous abortion

Is failing to attach even considered abortion? It seems like there should be some middle word beween contraception and abortion for that. A fertilized egg that hasn't attached is post-conception, but pre-pregnancy.

It's miscarriage, is what it is. Now the question becomes:

Much of the time, the lining of the womb just naturally does not accept the implantation of the zygote, and it winds up expelled as menstruation. The "morning after" pill makes it possible for the woman to create conditions where it doesn't implant.

So if God makes the conditions of the womb, and more than half the time, He creates a condition for this very type of early miscarriage, why would it be a mortal sin for the woman to create that condition?

If He knows that it will abort naturally, does He still provide the conceived zygote with a mortal soul?

I though miscarriage was when it lost its hold on the wall, not when it doesn't attach at all? Or is it both?

Both I think. Medline says,

A spontaneous abortion is the loss of a fetus during pregnancy due to natural causes. The term "miscarriage" is the spontaneous termination of a pregnancy before fetal development has reached 20 weeks. Pregnancy losses after the 20th week are categorized as preterm deliveries.

It's not the scientific details that are motivating these people from blocking it, they believe that sex before marriage is wrong and will oppose anything and everything that promotes it or makes it easier. Simple.

So much for stem cell research.....won't be any raw material.

No big loss. If we had stopped Reeve from misinforming so many people about it it wouldn't be so bad.

I wouldn't have thought that it was considered a fetus or a pregnancy before implantation.

Shrug. I dunno, it's the same Medline entry that says spontaneous abortion happens 50% of the time.

That is the legal opinion in this country:
From here

Whoa, there's been a hell of a lot of information floating around, and continues to be forthcoming, that has nothing to do with Reeve. You don't believe it? :confused:

I'm making more of a reference to the information used during the last election. Reeve made rounds with the Democrats playing up Bush's opposition to using federal money for stem cell research. He made outragous statements leading people to believe that people like him 'could have a cure' if only Bush wasn't stopping it. Complete bullshit. The state of the technology is this, we want to learn what it is about totipotent and pluripotent cells that allows them to become very specialized structures such as muscle or nerve bundles. They were giving people the idea that this would logically lead to the growing of whole organs and tissue replacements within a localized timeframe. That would have been like a scientist saying we need to research transistors so that we can build human-level AI systems.
I'm just saying he gave alot of people a very unrealistic view of what we can do or intend to do once given the ok with this.

I'm also ticked that everyone thinks this is all Bush's doing, it was Clinton and the Dickey Ammendment which made it illegal to use federal money to fund stem cell research which involves destroying an embryo.

Morning-after pill to be available without prescription
Buyers must prove they're 18 or older

Friday, August 25, 2006; Posted: 1:28 a.m. EDT (05:28 GMT)

Plan B will be available over the counter to women 18 or older, the Food and Drug Administration says.

Differences between the morning-after pill and the abortion pill, which are different drugs:

The morning-after pill prevents pregnancy but has no effect if a woman already is pregnant. Sold under the brand name Plan B, it's a higher-than-normal dose of a hormone found in regular birth-control pills and prevents ovulation or fertilization of an egg. It also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, but recent research suggests that's not likely.

The abortion pill, RU-486 or Mifeprex, can terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It's a two-pill process. First is Mifeprex, which blocks production of a hormone required to sustain pregnancy. Then a second medicine, misoprostol, to cause contractions and finish the abortion.
WASHINGTON (AP) -- Women can buy the morning-after pill without a prescription, the government declared Thursday, a major step that nevertheless failed to quell the politically charged debate over access to emergency contraception.

The manufacturer, lawmakers and other advocates said they will press the government to allow minors to purchase the pills over the counter.

The Food and Drug Administration said that women 18 and older -- and men purchasing for their partners -- may buy the Plan B pills without a doctor's note, but only from pharmacies.

Girls 17 and younger still will need a prescription to buy the pills, the FDA told manufacturer Barr Pharmaceuticals Inc., in ruling on an application filed in 2003.

Still at odds
The compromise decision is a partial victory for women's advocacy and medical groups, which say easier access could halve the nation's 3 million annual unplanned pregnancies.

"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. The U.S. has one of the highest rates of teen pregnancy in the Western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," president Cecile Richards said.

Opponents contend that nonprescription availability could increase promiscuity and promote use of the pills by sexual predators.

"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, who led the opposition.

Pregnancy risk reduced
Plan B contains a concentrated dose of the same drug found in many regular birth-control pills. Planned Parenthood estimates 41 other countries already allow women to buy emergency contraception without a prescription.

If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is different from the abortion pill: If a woman already is pregnant, Plan B has no effect.

The earlier the pills are taken, the more effective they are. Allowing nonprescription sales mean women won't have to hustle to get a prescription, something especially difficult on weekends and holidays, advocates said.

The FDA's long delay in deciding on Barr's application ensnared President Bush's nominee to head the regulatory agency. On Thursday, two senators said they would lift their Plan-B-related block on Dr. Andrew von Eschenbach.

In recent weeks, anti-abortion groups, angered that approval was imminent, had urged Bush to withdraw von Eschenbach's nomination. Bush said Monday that he supported the doctor's decisions.

Only at pharmacies
Barr 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, but not at convenience stores or gas stations. Pharmacists will check photo identification.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo. Over-the-counter use is safe for older teens and adults, the acting FDA commissioner added in explaining the age cutoff.

"This approach should help ensure safe and effective use of the product," wrote von Eschenbach.

Barr and others were disappointed that FDA imposed the age restriction. Bruce L. Downey, Barr's chairman, pledged to continue working with the agency to try to eliminate it.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press. Galson has acknowledged overruling his staff scientists, who concluded in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue.

Age-limit enforcement
As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.

"I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced," said White House spokeswoman Dana Perino.

Barr hasn't said whether it will raise the price of the pills, which now cost $25 to $40 in prescription form.

Planned Parenthood, the largest dispenser of the pills, expects some insurers to continue covering prescription sales. Whether that would be cheaper will depend on a woman's insurance.

Nine states -- Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont -- already allow certain pharmacies to sell Plan B without a doctor's prescription to women of any age.

Minors won't see any change in those states, because the pharmacist already technically writes the prescription, the American Pharmacists Association said.

The FDA approved prescription-only sales of Plan B in 1999. The quest to change its status began in 2003. That year, agency advisers endorsed nonprescription sales for all ages, and FDA's staff scientists agreed.

Higher-ranking officials rejected that recommendation, citing concerns about young teens using the pills without oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce the age restrictions.

FDA's handling of Plan B sparked a firestorm, with allegations of political meddling, high-profile resignations, lawsuits and congressional investigations.

The controversy appears to have helped Plan B sales, which are up an estimated 30 percent this year, according to IMS Health Inc., a health care consulting company. Barr estimates pharmacists dispense about 1.5 million packs a year.

Copyright 2006 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

Obviously it's a Yay! from me, but I wonder if it will actually make any difference. I admit ignorance on the way your legal system works, but I guess if 9 States had already legalised it, then surely if the others wanted to they would have? I also seem to remember something on TV that suggested while abortion is legal, one State (one of the Dakotas maybe?) now had no Doctors willing to perform the procedure, and in fact the only willing Doctor covered 3 States and was about to retire. This is from memory, but am pretty sure that was the case.

The only other comment I can make is that I don't think statistics bear out the assumption the morning after pill reduces teenage pregnancy. Again, I may be wrong, but my PCT has one of the highest teenage pregnancy rates in the country and as stated before we were running a free of charge OTC service... EHC mops up after responsible people who worry about unsafe sex and whether they are pregnant. [generalisation] That doesn't seem to include most teenage mothers. [/generalisation]

I say get them all fitted with a 3 year implant. I'm only half joking (I have one myself)

ROB KIM / LANDOVThe FDA approved Plan B, an emergency contraceptive used to prevent pregnancy available without a prescription to women 18 and older, on August 24, 2006.
Nation
Why the Plan B Debate Won't Go Away
As the FDA approves the morning-after pill for over-the-counter sales to adults, conservatives beat up on the federal agency and the drugmaker begins its push to make Plan B available to younger women
By LAURA BLUE

Posted Friday, Aug. 25, 2006
The Food and Drug Administration may have ended a three-year health-policy dispute when it approved the "morning-after pill," Plan B, for over-the-counter sale yesterday. But fallout from the political feud surrounding Plan B will play out for months. Democratic Senators Patty Murray and Hillary Clinton dropped their objections Thursday to confirming Andrew von Eschenbach, acting FDA commissioner since September 2005; the Senators had vowed to stall von Eschenbach's nomination at the committee stage until the emergency contraception was made available over the counter. But more bitter response erupted immediately from conservative and faith-based groups, some calling on President Bush to withdraw von Eschenbach's nomination altogether because of the pills that, if taken within 72 hours of unprotected sex, can greatly reduce the chance of pregnancy.

Both sides of the debate were quick to decry the FDA's ruling as political. "Clearly in this case corners were cut," says Family Research Council health policy analyst Moira Gaul, claiming the FDA overlooked what her group calls a lack of safety evidence. Backers of Plan B, on the other hand, were angered by the FDA's age restrictions on the drug: patients under 18 must still have a prescription to get the drug, even though the FDA's own scientific advisers never recommended such a policy. "They have been playing politics with this issue for 40 months," says Jackie Payne, director of government relations for the Planned Parenthood Federation of America, of FDA leadership. "They're continuing to play politics with teens."

Plan B is a synthetic form of progesterone, a hormone commonly used in birth-control pills, and it works by by preventing ovulation, preventing fertilization of the egg, or stopping a fertilized egg from lodging in the uterus. The FDA first approved Plan B, now owned by Delaware's Barr Pharmaceuticals Inc., for use with a prescription in 1999, but the controversy erupted in 2003. That's when FDA officials rejected the recommendation of their scientific advisers and refused to grant Plan B approval for over-the-counter use. The acting director of the Center for Drug Evaluation and Research at the time, Dr. Steven Galson, said the drug should not be sold over the counter because there was insufficient evidence to suggest that teenagers would be able to self-administer the drug safely. Critics slammed Galson and other FDA officials, and said going against the medical experts' opinion was a sign that FDA leadership had caved to conservative political pressure.

In fact, the FDA considered exactly the same studies when it approved the drug Thursday as it did when it denied the drug over-the-counter sales in 2003. The difference? When Barr resubmitted the application for over-the-counter approval, it limited its request to those patients 16 and older. (A Barr spokeswoman tells TIME it was hard to recruit many girls aged 15 and younger for the kind of studies the FDA wanted, since young teens make up such a small segment of the population needing emergency contraception.) The decision to limit over-the-counter sales to women 18 and up was a compromise reached by the FDA and announced by von Eschenbach — and it's a decision that Barr still intends to challenge. "We'd like to continue to do clinical work now to address the younger patients," says spokeswoman Carol Cox. In the meantime, Cox says, Barr plans to have its brand-new single-purpose prescription and over-the-counter packaging ready to ship out by the end of 2006.

The ethical debate, however, is going nowhere fast. Pro-lifers who believe life begins at conception, consider the contraceptive tantamount to abortion, and social conservatives fear that emergency contraceptives will encourage promiscuity. (A California study published in 2005 in Obstetrics and Gynecology found no link between the availability of the morning-after pill and sexual activity.) Meanwhile, even as groups like Planned Parenthood are heralding yesterday's decision as a victory for reproductive rights, they are angered that teens still face obstacles to getting emergency contraceptives. Perhaps the one thing they all agree on is that Plan B could have been handled better.

This came to my attention this week:

From the Guardian re pregnant mothers who abuse drugs are considered to be commiting child abuse

Precis:
I just can't see that women who are addicted to hard drugs are going to suddenly turn their life around because of a possible conviction. Those who care about their unborn child may find the strength to do so - but they would have done it without threat of punishment.

Isn't this just a "feel good" solution for the law abiding middle classes? In the same way that refusing to provide the morning after pill to girls legally entitled to have intercourse is?

It costs £81 in Britain (US $152) to have an implant for 3 years. It can be removed at any point and the woman will be fertile from the moment of removal. It costs so much more to deliver a baby, put someone on trial and imprison them. Why aren't more women at risk of unwanted pregnancies being helped not hindered?

Sorry, I know it's a hobby horse. I would honestly be interested in arguments against.

So, it is your belief that someone who breaks the law habitually is, somehow, just someone with bad habits that we should feel sorry for?
Class has nothing to do with it... breaking a law is breaking a law, white collar crime or any other should be treated the same.
I feel some laws are wrong and fight to change them, sometimes I break them but know what will happen if caught & will have no one to blame but myself.

I just wonder what this new law hopes to achieve? It's specifically targeting people who have not shown any previous regard for the law.

I'm not suggesting that as law breakers they require cosseting - just in the case of addiction I believe it's more sensible to offer help rather than punishment. De-tox isn't a soft option. If they go to gaol the chances of them detoxing - sadly - are minimal. It's certainly more cost effective in the long run to get someone off drugs than to keep locking them up.

And in the specific case of pregnancy, more cost effective to a) get them off drugs or b) offer them the chance not to produce drug addicted babies.

Of course I'm coming from a UK perspective where free contraception is avilable to everyone.

Well, they got Al Capone on tax evasion... it makes it possible to attach a much more serious penalty onto drug laws, which have been historically hard to enforce. Actually, I think this law is going to have a pro-abortion effect, not an anti-. If Jane the Crack User gets pregnant, she knows that rather than yet another court-ordered probation/substance abuse clinic/short jail term, she can now be convicted of murder if she keeps using, which she knows she will. She may decide it's better to get an abortion than to just pray the baby will be okay (or have it for the sole purpose of getting a support check from the father.)

Which is probably a positive thing, with one slight caveat. Once we get our laws straightened out and the aborted fetuses are put to scientific use we'll need to know what substances the mother was addicted too. Shouldn't be much more complicated than tacking $10 onto the price of an abortion for maternal blood tests though.

Or they can just scrape a sample off the coathanger, if the life proponents have their way.:eyebrow:

Sorry... this is a really long post.

Just because someone has shown no previous regard for the law doesn’t mean that they shouldn’t be punished. I have had first hand experience with a drug addict, my sister. She never gets the punishment she deserves because the judge doesn’t think it will do any good. And I am not just speculating their reasoning, they said so themselves. And because she always gets off light, she continues to do the same things that have her end up in a courtroom. I think that the more they are punished, the more likely they will be to stop doing what is illegal. Now, it will take time for this to occur. But at least they would be more careful about how they acted if they knew that they would go to jail for a year for one offense.

I know that the one time that they actually gave her a long sentence (1 year and 145 days but she got out in six months) she didn’t break the law for several months after she got out (which is a record for her, I can assure you). She has been in detox and drug rehab over a dozen times but it doesn’t do anything. She will stay clean for the duration of de-tox but as soon as she gets out she starts up again. When she goes to rehab she just tells then what they want to hear. She has been through their program so many times that she has memorized everything she can say to get them to let her out.

Basically the only thing that has even put a dent in her attitude was jail. She needs to be locked up so she isn’t a nuisance to society (and to her family as well for that matter). I will admit that a large problem with her is our grandmother won’t say no to her. Whenever she needs a place to stay, she goes to our grandmother. Whenever she needs a ride, she goes to our grandmother. When she needs money, or food, or help in any way she goes to our grandmother. Sometimes my grandma will say no to giving her money or rides, but for the most part my sister walks all over her. And we are all helpless to stop it. We are actually in the process of moving my grandma to an apartment so she won’t have room for my sister. Then she has a legitimate excuse to tell her to go away. Oops, here I go rambling on and on about my family and getting off subject.

Back to the subject… contraception is also available to everyone here for free (that can’t afford it) as well, at least in Kansas. The problem is that the contraception offered is condoms and birth control pills, and the drug addicts aren’t responsible enough to use them as they need to be used and they end up pregnant anyway. Or they are too lazy to actually go to the clinic and get it. If they were offered the shot or the implant I think that would help things tremendously. Of course then there would be those who didn’t go back on time, but since they last so much longer than condoms or pills it is less likely they will get pregnant. Or at least they wouldn’t get pregnant but every 3 to 5 years.

Sorry to hear about all you've been through with your sister Iggy. I do appreciate you know more about addicts than I do.

I just feel that in creating a law that makes a woman responsible legally for the health of her unborn child in order to get more addicts into prison, we are at the top of a slippery slope.

I also feel - because of the culture I've grown up in - that money spent on prevention, counselling, programmes and therapy is worth more than threats, especially once someone has already dropped out of normal society.

I'm not refuting any of your testimony, just didn't want to leave a long and interesting post unanswered.

Thank you for your post Sundae Girl. I definitely see what you mean about money spent on prevention is worth more than threats. The only problem with that is addicts are not rational people. I wish that we could use counseling and prevention methods to stop what is happening, but seeing as how they are not rational in their behavior I fear that those wonderful programs would go unused.

If only we could prevent them from getting pregnant then things would be so much better. And I do agree that prevention would be better, but with my experience I doubt that it would help considering that the people who would be using it are addicts.

I just wanted to let you know that your opinion is valid and would work in situations where there were rational people. But as I said, addicts are not rational. But thank you again for responding.