September 28 11:47 AM ET

FDA Approves Abortion Pill RU-486

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WASHINGTON (Reuters) - U.S. health officials approved the abortion pill RU-486 on Thursday, clearing the way for its sale after years of political battles and delays that had kept it off the U.S. market.

The pill, also known as mifepristone, can induce an abortion early in pregnancy without surgery. The government's Food and Drug Administration (FDA) announced the decision to approve the pill in a statement.

Supporters have been trying to bring mifepristone to the U.S. market for more than a decade. The drug made its debut in France in 1988 and now is sold throughout Europe, in China and elsewhere.

But pressure from groups that oppose abortion has helped scuttle the pill's U.S. entry in the past. Passion against abortion is so high that clinics have been bombed, and doctors and clinic workers have been harassed and killed.

With mifepristone, women and doctors may have more privacy from protesters and access to abortion may widen, particularly in rural areas where there are no clinics, the pill's supporters say.

-- (hmm@hmm.hmm), September 28, 2000

Answers

I am glad to hear this news. But I fear that the rearguard action will continue for some time to come. Abortion opponents know that keeping RU-486 off the market is a much easier task than pulling it off the shelves once it reaches the market. I expect they'll file lawsuits in friendly federal court districts that can tie this up for many more years to come.

Another example of better living through chemistry. (I just had to say that...grinning, ducking and running.)

-- Brian McLaughlin (brianm@ims.com), September 28, 2000.

Anyone know what the difference is between this and the "morning after" pill [if any]? I remember one of my daughters telling me that her doctor gave her a "morning after" pill because the condom broke. We had a long talk about why she wasn't using "back-up" contraception at that time. She is NOW!

-- Anita (Anita_S3@hotmail.com), September 28, 2000.

More info

Thursday September 28 12:46 PM ET

FDA Approves Abortion Pill

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON (AP) - The Food and Drug Administration (news - web sites) on Thursday approved U.S. use of the abortion pill RU-486, a major victory for those who battled for 12 years to bring the early- abortion method to this country.

Proponents say the pill, which has been used by millions of women in 13 countries, could transform abortion in the United States by making it more accessible and more private. But it can be used only in the earliest days of pregnancy.

It could be available to doctors within a month.

``For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative,'' said FDA Commissioner Jane Henney.

Anti-abortion organizations have fought to keep RU-486 out of the United States since the drug debuted in France in 1988. They pledged to continue the fight.

``We will not tolerate the FDA's decision to approve the destruction of innocent human persons through chemical abortion,'' said Judie Brown of the anti-abortion American Life League.

Worried about anti-abortion violence that has sprung up in recent years, the FDA has increased security in some of its offices and, in an unusual move, Henney is keeping secret the names of the medical officers who reviewed the drug.

``The climate around the reproductive-rights issue and personal safety issues are in our minds,'' she said.

To ensure the pill is used accurately and safely, the FDA mandated that women be given special brochures called ``MedGuides'' explaining who is eligible for a pill-caused abortion and what side effects to expect and that they must make three trips to the doctor for the procedure.

RU-486, now known by its chemical name mifepristone, can be used only within 49 days of the beginning of the woman's last menstrual period. The woman takes three mifepristone pills. Two days later, she returns to the doctor to swallow a second drug, misoprostol, that causes uterine contractions to expel the embryo. She returns for a follow-up visit within two weeks to make sure the abortion is complete.

The FDA will allow mifepristone to be distributed only to doctors trained to accurately diagnose the duration of pregnancy and to detect ectopic, or tubal, pregnancies, because those women cannot receive mifepristone.

Also, the FDA restricted mifepristone's use to doctors who can operate in case a surgical abortion is needed to finish the job or in cases of severe bleeding - or to doctors who have made advance arrangements for a surgeon to provide such care to their patients.

Studies show mifepristone is 92 percent to 95 percent effective in causing early abortion, by blocking action of a hormone essential for maintaining pregnancy. Without that hormone, progesterone, the uterine lining thins so an embryo cannot remain implanted and grow.

The pill-induced abortion can be painful, causing bleeding and nausea. Heavy bleeding is a potentially serious side effect but one the FDA determined is rare. In safety testing of the first 2,100 American women who took mifepristone, four bled enough to need a transfusion.

A small New York company, Danco Laboratories, will market mifepristone under the brand name Mifeprex. It should be available in about a month. Abortion providers say the pill-caused abortion should cost the same as surgical abortion, but a Danco spokeswoman refused to confirm that Thursday.

The FDA's decision, coming in the midst of the presidential election campaign, is sure to generate fierce new controversy. Republican candidate George W. Bush (news - web sites) opposes abortion; his father's administration banned RU-486 from this country in 1989. The pro-choice Clinton-Gore administration worked for seven years to bring mifepristone here.

Proponents argued that a pill-caused abortion offers a surgery alternative that feels more like a miscarriage and typically is offered earlier in pregnancy than surgical abortion.

Bowing to that pressure, French manufacturer Roussel-Uclaf in 1994 turned over U.S. rights to the drug to the nonprofit Population Council of New York, which launched U.S. clinical trials needed for FDA clearance. Although the FDA actually declared mifepristone a safe and effective abortion method in 1996, final approval was delayed until now because Danco, created to market the drug, had trouble meeting federal manufacturing and labeling requirements.

The vast majority of today's 1.3 million annual U.S. abortions are surgical, although doctors in 1995 began publicizing the fact that a drug already sold to treat cancer, methotrexate, also could be used to induce abortion.

Health experts say mifepristone won't increase abortions - that didn't happen in Europe. But the FDA's formal approval may encourage more doctors who don't offer surgical abortions to offer the pill, thus making it easier for women, particularly in rural areas, to get an abortion without traveling hundreds of miles or entering surgical clinics often staked out by protesters.

The National Abortion Federation, which accredits abortion providers, said 240 of its member clinics were already prepared to offer Mifeprex, and it is training other physicians in how to use the pill.

-- Peg (too@much.spam), September 28, 2000.

>> Anyone know what the difference is between this and the "morning after" pill [if any]? <<

I am relying on memory here.

As I recall, the "morning after pill" is essentially an extra large dose of estrogen (hell, or is it progesterone?), similar to taking several "standard" birth control pills. It only works well if taken very soon after insemination (a couple of days?). By consolidating the dose into one pill, and prescribing it separately from normal birth control pills, it reduces the chances of misdosing oneself.

RU-486 is capable of inducing a miscarriage well beyond the couple of days horizon for the morning after pill. As such, it is seen as more of a substitute for standard abortions in the first trimester or so.

As always, the best source of info would be Planned Parenthood. I bet they have a web site where this stuff is explained better than I can explain it.

-- Brian McLaughlin (brianm@ims.com), September 28, 2000.

Anita,

Emergency Contraception

snip

Types of emergency contraception:

An emergency contraceptive pill (ECP), a.k.a. the Yuzpe regimen. This contains an elevated dose of oral contraceptives containing estrogen (ethinyl estradiol) and a progestin (levonorgestrel or norgestrel) is taken within 72 hours of unprotected intercourse. This is followed by a second dose 12 hours later. This method has been in use for over 20 years. Gravol pills are often given in addition to the ECP, to reduce side-effects. An alternate ECP contains a high dose of either estrogen or a progestin alone, without estrogen. There is less clinical experience with this medication. The insertion of a Copper T Intra-Uterine Device (IUD) within 5 days of unprotected intercourse is sometimes used. The IUD changes the environment of the uterus in ways that are not entirely clear; the result is that a fertilized ovum will not be able to attach itself to the endometrium, the lining of the uterus.

-- Peg (too@much.spam), September 28, 2000.

Unborn life is now so disregarded that we end that life with a pill.

-- J (Y2J@home.comm), September 28, 2000.

Thanks, Peg. I seem to remember the morning-after pill preventing conception rather than aborting it.

-- Anita (Anita_S3@hotmail.com), September 28, 2000.

The FDA stood up and made the right decision, despite the strident outcrys of a vocal minority. I applaud them.

-- Tarzan the Ape Man (tarzan@swingingthroughthejunglewithouta.net), September 28, 2000.

The FDA caved in and made the wrong decision, despite the silent outcrys of an unborn minority. I abhor them.

-- J (Y2J@home.comm), September 28, 2000.

Follow the money.

-- Lars (lars@indy.net), September 28, 2000.

I've noticed that there seems to be a lot of anger and upset about this decision from the compulsory pregnancy camp. Here's an illuminating quote from a CNN story:

For Cirmo, the abortion pill, means that anti- abortion groups like hers will not be able to counsel women. "It will be harder to reach those women considering an abortion," she told CNN. She called on "those who do value life to go to the polls" and elect an anti- abortion president, who could overturn the FDA decision.

I've been a clinic escort for quite some time now, and I've seen more than my fair share of the "counseling" these women are subjected to. I've seen women shouted at, threatened, called everything from sinner to whore. I've seen objects hurled and blame tossed all over the place. I've never seen anything even close to the quiet dialogue the word "counsel" brings to mind.

If RU 486 keeps even one woman from going through the harrowing experience, then the whole ten year battle for approval was worth it.

-- Tarzan the Ape Man (tarzan@swingingthroughthejunglewithouta.net), September 28, 2000.

Yes! Follow that money trail. I suspected that it would be a matter of time before the abortion pill was approved here because of the vast, untapped market.

But no complaints from me! Even if the pill has been approved for the "wrong" reasons, I am thankful that American women have this option.

-- (raven@never.more), September 28, 2000.

I think this is a good thing. It puts the choice squarely with the woman where it belongs.

Ape-man,

I agree with you. My brother and sister-in-law lived in a small apt above a OBGYN office. Those religious nuts are awful, sneaky, boorish people.

For Cirmo, the abortion pill, means that anti- abortion groups like hers will not be able to counsel women. "It will be harder to reach those women considering an abortion," she told CNN. She called on "those who do value life to go to the polls" and elect an anti- abortion president, who could overturn the FDA decision.

The two party bullshit sucks. I either get a guy who wants to take away my Second Amendment rights, or one who wants to send women back to the alleyways.

Go Harry Browne.

-- Uncle Deedah (unkeed@yahoo.com), September 28, 2000.

Unk-

Harry Browne is against abortion.

-- Tarzan the Ape Man (tarzan@swingingthroughthejunglewithouta.net), September 28, 2000.

Harry wants the issue left to the states, as it should be per a small document called the US Constitution.

-- Uncle Deedah (unkeed@yahoo.com), September 28, 2000.

BTW, as a clarification. Libertarians are as divided over the abortion debate as is the population in general. Mostly we are pro- choice in everything. I think a woman has a right to chose, Harry thinks it should be left to the states. What we agree on is that the federal government has no business outlawing it.

-- Uncle Deedah (unkeed@yahoo.com), September 28, 2000.

Oh, sorry. I must have misunderstood Browne in the evote.com chat where he said, "I oppose aborion strongly," and his book, Why Government Doesn't Work, where he said that life begins at conception and abortion is wrong, very wrong. He does seem to think that the states should decide whether to legalize abortion in their borders or not, unless I'm misunderstanding that, too.

-- Tarzan the Ape Man (tarzan@swingingthroughthejunglewithouta.net), September 28, 2000.

Unc.....

It's not for the State or Fed to chose... It's for me and Mine...... It's a PERSONAL !!!!!!!!!!!!!... choice....... get it right next time.... ;-)

-- Netghost (ng@no.yr), September 28, 2000.

It might be construction to remember that the clinical/legal definition of death is when the heart stop beating.

-- Hiway (Hiway441@aol.com), September 29, 2000.

OK, seems like I need to point out that in my post, four above this one, I stated that Libertarians are divided on this issue.

Ape-Dude,

In the interviews I have seen, Harry states that even though he personally hates abortion and believes that it is wrong, he would hate it even more if the federal government had the power to enforce his view on others, therefore he would leave it to the states to decide. Is that a perfect position? Probably not, but considering the fact that most folks who dislike abortion want it outlawed on the federal level, I thought it was a pretty reasonable stance.

My statement "Go Harry Browne" reflected my disgust with the fact that we as a nation have limited choices, it's just that you would never hear me say "Go Ralph Nader".

-- Uncle Deedah (unkeed@yahoo.com), September 29, 2000.

I have not yet heard "Go OTFR!" on this forum, no matter how hard I try. Being a moderator taught me that it is impossible to completely please even one single person, because to be fair to everyone, compromises need to be made. In that sense I feel for politicians. But they're masochists to choose that career.

Just thought Id take this opportunity to get this off my chest. Going back to my hole now ;-)

-- Old Time Forum Regular (freespeech@yahoo.com), September 29, 2000.

Go OTFR

-- (hmm@hmm.hmm), September 29, 2000.