Fed Panel Backs Easier Morning-After Pill

AP ^ | December 17, 2003 | LAURAN NEERGAARD

[Diamond]

December 17, 2003, 6:38 AM EST

WASHINGTON -- Women may soon have an easier way to help prevent pregnancy after unprotected sex now that government advisers have recommended that morning-after birth control should be sold without a doctor's prescription.

"It's extraordinarily safe," said Dr. Alastair Wood of Vanderbilt University, an adviser to the Food and Drug Administration.

In fact, he said, women probably should keep emergency contraception in their medicine cabinet just in case it's ever needed. "We don't tell people to buy a fire extinguisher after the fire started."

The panel on Tuesday voted in favor of over-the-counter sales of emergency contraception amid concerns from anti-abortion critics and worries from others that easier access to morning-after pills may increase unsafe sex, particularly among teenagers.

But proponents argued there was no evidence that emergency contraception lulls women into complacency about regular birth control or disease. They said wider use of the morning-after pill could cut in half the nation's 3 million unintended pregnancies each year and in turn prevent hundreds of thousands of abortions.

"There is a public health imperative to increase access to emergency contraception," said Dr. Vivian Dickerson, president-elect of the American College of Obstetricians and Gynecologists.

The FDA isn't bound by its advisers' recommendations but usually follows them. A decision is expected in late February.

Asked whether political considerations would be taken into account, FDA Commissioner Mark McClellan said, "We have a lot of information coming in. It's very much a science-based process."

The morning-after pill is simply a higher dose of regular hormonal contraception, and is sold by prescription under the brand names Plan B and Preven. Plan B's manufacturer wants to sell the drug without a prescription, putting it on pharmacy shelves next to the aspirin and cough medicine.

Taken within 72 hours of intercourse, the pills cut the chances of getting pregnant by up to 89 percent. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays, contraceptive advocates and the nation's largest gynecologists group told the FDA on Tuesday.

Morning-after pills prevent ovulation or fertilization, and possibly interfere with implantation of a fertilized egg into the uterus, the medical definition of pregnancy.

If a woman already is pregnant, they have no effect. Consequently, emergency contraception hasn't proved nearly as controversial as RU-486, the abortion pill.

It does have critics who oppose any interference with a fertilized egg, and who argued Tuesday during a daylong hearing that broader access could increase sexually transmitted diseases, especially in teens.

"Without medical advice, use of Plan B by teens will be disastrous," said Dr. John Bruchalski of the Catholic Medical Association.

Some of FDA's advisers did want teen access to nonprescription Plan B restricted, arguing there wasn't enough study of the drug in minors.

Also, "I'm concerned there will be an exploitation of young women's fears about becoming pregnant," leading them to overuse, said panelist Dr. Susan Crockett, a Texas gynecologist.

But the FDA responded that there are no age restrictions on prescription Plan B and that it couldn't enforce any on an over-the-counter version. Other advisers said teens in particular should avoid pregnancy.

The FDA asked its scientific advisers whether women could use the drug properly without professional advice. They could, the panel decided, voting 23-4 to recommend over-the-counter sales.

The key, they cautioned, would be clearer wording on the package so that women understand:

* The drug must be used as soon as possible after unprotected sex. Although it's effective for 72 hours, and possibly a little longer, it works best in the first 24 hours.

* Like other hormonal contraceptives, it does not protect against sexually transmitted diseases.

* It is a backup contraceptive, and should not be used instead of routine birth control.

Cost could deter some women from using emergency contraception too regularly. Each one-time-use pack today costs $20 to $30, about as much as a month's worth of regular birth control pills. It's not clear if the over-the-counter price would change.

Manufacturer Barr Laboratories promised a massive consumer education campaign, including a 24-hour hot line for advice on using the drug.

To improve access, California, Washington, Alaska, Hawaii and New Mexico already allow women to buy the morning-after pill directly from certain pharmacists without a prescription.

The FDA should not require pharmacists to dispense Plan B, most advisers agreed.

[Diamond]

Sorry I couldn't find a better source for the information.

Cordially,

[workerbee]

Morning-after pills prevent ovulation or fertilization, and possibly interfere with implantation of a fertilized egg into the uterus, the medical definition of pregnancy. If a woman already is pregnant, they have no effect.

There it is again, the eternal contradiction so loved by the abortion lobby. The deliberate ignorance pushed by the media about this issue is getting really really old. If you're so all-fired proud of your "right" to end a pregnancy, why can't you have the gonads to admit just what a pregnancy is????

[Diamond]

Exactly. The interference with the implantation of a fertilized egg is not contraception, although it would be difficult to discern that from reading this article.

I have visions of underage girls buying these substances at the local grocery store, attempting to eliminate the 'evidence' of their sexual encounters. What a thought.

Cordially,

[Diamond]

You might want to ping this to your list. I find it an insane policy to allow the sale of these substances over the counter at all, not to mention with NO age restrictions, but then again when it comes to (potential) abortifacients, all is apparently sacrosanct.

Cordially,

[Huck]

It appears that they consider pregnancy to be an implanted fertilized egg, not just a fertilized egg. It's my understanding that even without medical intervention, sometimes fertilized eggs don't implant and come out with the wash, so to speak. Those instances aren't really even known, and are not considered pregnancies, right? I realize some people consider pregnancy to begin when an egg is fertilized, which makes regular birth control pills just as bad as this pill. Right?

[Diamond]

After looking at my reply to you, I find that I should clean up my language. The 'implantation of a fertilized egg' is a misnomer, to say the least, because once fertilization occurs, both ovum and sperm cease to exist, having become an new human being.

Cordially,

[sweetliberty]

Isn't it funny that there never seems to have been any such push to make birth control available OTC, but an abortion pill is just peachy.

My level of tolerance for anything liberal/socialist/communist has hit rock bottom. These people can just go to h**l!

[Diamond]

These are not necessarily abortifacients, but since a woman cannot know in advance when any of these drugs will prevent fertilization or block implantation, they cannot be ingested without moral and/or physical consequences.

Cordially,

[longtermmemmory]

ruffie users rejoice!

child abusers rejoice!

[Coleus]

Morning After Pill.org

ALL 1
ALL 2
ALL 3
ALL 4, letter to editor

Weblog: FDA Panel Recommends Over-the-counter 'Morning After' Pill
2
3

[Honestfreedom]

Pardon my curiousity but doesn't the IUD do the same thing? Nobody has ever suggested they should be illegal.

[Romulus]

It appears that they consider pregnancy to be an implanted fertilized egg, not just a fertilized egg.

Introduction of the term "pregnancy" is a sleight-of-hand, a trick to deceive the slow-witted. Pregnancy is not the point. Human life is the point. When an embryo has naturally failed to implant, human life has come to a natural end.

[GovernmentShrinker]

sometimes fertilized eggs don't implant and come out with the wash, so to speak

MOST of the time fertilized eggs don't implant. In fact, in the natural course of things, over the full range of women's reproductive years, only about 1 in 20 fertilized eggs ever become a full term baby.

[GovernmentShrinker]

Plenty of these zealots have suggested that IUDs, birth control pills, and everything else, should be illegal. It wasn't so many years ago that Robert Bork was arguing in court that it was perfectly fine for the state of Connecticut to make it illegal for even married couples to obtain ANY sort of contraceptives.

[longtermmemmory]

IUD has to be put in by the woman. It can't be snuck in.

I have a problem with the fact that this unregulated system provides ready cover for those who engage in any form of abuse. Whether it is a boyfriend, rapist, or someone who wants to make sure the minor they had sex with does not get pregnant.

There are waaaaay too many problems with the unregulated distribution.

Is every pharmasist goint to ask if this is for a minor? What if a man is buying this? Is it for his wife or daughter and they are having the man buy the drug because the woman is too embarassed? There is no way to know or protect the innocent.

What about a frat party where women are all given "plan B" in advance of any activity?

The pill may work and that may be all well and good but just as abortion clinics have to report minors who have sex to police for statutory rape purposes, a similar mechanism has to be in place for the distribution of this pill.

You can't and should not stop adults from KNOWINGLY obtaining this. You should unknowing consumption and facilitating child abuse and/or rape.

[GovernmentShrinker]

Huh? Good old-fashioned latex enables all the things you list. I suppose those should require a prescription too? Or is only options which allow women to have control that you object to being freely available?

[MEGoody]

"Women may soon have an easier way to help prevent pregnancy after unprotected sex"

Excuse me, but if these women aren't smart enough to use protection in the first place, what makes anyone think they are smart enough to use these medications correctly?

[MEGoody]

"MOST of the time fertilized eggs don't implant. In fact, in the natural course of things, over the full range of women's reproductive years, only about 1 in 20 fertilized eggs ever become a full term baby."

Got a link to a study on this? I'm curious as to how they conducted their research.

[BikerNYC]

When an embryo has naturally failed to implant, human life has come to a natural end.

Should we have funerals for those of us who fail to become implanted?

[GovernmentShrinker]

Haven't got a particular link handy, but there are lots of studies out there on the subject of fertilization/implantation/pregnancy rates, and Google will get you to at least abstracts of many of them. Needless to say, the rates are wildly different for young women vs. older women, but when I've looked at the rates for different age groups, it averages out to about 1 in 20.

The biggest factor is that as women get older, an increasing percentage of their eggs are no longer chromosomally normal, and while nearly all are capable of fertilization, most simply stop dividing very early on, often before implantation can occur. Some implant and naturally miscarry later, and a few survive to be born with Downs Syndrome or other serious genetic defects. Nature tries hard to flush out defective embryos.

But another big factor is timing. Even in young healthy women, uterine receptivity does not correlate precisely with ovulation and potential for fertilization. Thus a lot of eggs are fertilized at a time when it is simply impossible for them to implant, no matter how perfect they are.