February 25, 1997 in Nation/World

Fda Approves Pill For ‘Morning After’ Feds Free Doctors To Prescribe ‘Emergency Contraception’

From Wire Reports

An activist Food and Drug Administration made it easier Monday for women to avoid getting pregnant as it championed use of the contraceptive pill as “emergency contraception” after unprotected sex.

The FDA action almost certainly will increase use of a technique already tried by hundreds of thousands of women in this country.

Some researchers estimate that wide use of emergency contraception could cut in half the 3.5 million unintended pregnancies and the 1.6 million abortions that occur each year in this country.

“In my mind, this is the single most important step we can take to reduce the unacceptably high number of unintended pregnancies,” said Princeton University population researcher James Trussell.

Public health groups said the move could prove especially useful in preventing unwanted pregnancies among teenagers, the sexually inexperienced and rape victims.

“I think every person should have this in their medical cabinet,” said Janet Benshoof, president of the Center for Reproductive Law and Policy, a nonprofit group that favors the FDA move. “Everyone should have this - like they have aspirin or Band-Aids.”

But other groups warned that the technique was essentially abortion, and they predicted that it would increase sexual irresponsibility.

“You’re going to lose the battle in having people control their hormones and take a stand against premarital sex and unwanted pregnancy,” said Gracie Hsu, a policy analyst with the Family Research Council, a conservative group that focuses on family issues. “You are encouraging the idea that sex has no consequences.

“You also remove another barrier for women to be resistant to men’s unwanted advances,” she said. “He could say, ‘this won’t be a problem, you could take the morning-after pill.”’

Pill manufacturers, fearing litigation, distanced themselves from the FDA move. At least one company said that it had no plan to market the pills for such use.

In a notice published in the Federal Register, the FDA recommended that if a woman has unprotected sex and doesn’t want to get pregnant, her doctor should give her a strong dose of contraceptive pills within 72 hours, followed by another dose 12 hours later.

The agency says that if 100 women had unprotected sex once during the second or third week of their menstrual cycle, eight would normally be expected to become pregnant. With the procedure, two would get pregnant.

FDA officials said that the approach does not induce abortion, since most medical authorities agree that pregnancy begins at the time the fertilized egg becomes implanted in the uterus. High doses of birth control pills prevent ovulation, fertilization and implantation of the egg in the uterus. If the embryo has already become implanted in the uterine wall, the drugs will not cause an abortion.

Side effects of the procedure include nausea and vomiting. Researchers say it does not affect longrange fertility.

The FDA took the action on its own initiative.

Critics charged that Monday’s decision was purely political, and pointed out that the drug companies who make the pills don’t want to label them for emergency contraception.

“Not one pharmaceutical company has asked the FDA to do this,” said Judie Brown, president of the American Life League, a grass-roots anti-abortion organization. “This has been done by the pro-abortion forces in Washington.”

“Emergency contraception is abortion,” she said. “It interferes with the uterine lining and causes the embryo to die and that is abortion.”

She warned that the group will keep up protests and pickets at stockholders meetings of the companies.

In a statement, Audrey Ashby, a spokeswoman for Wyeth-Ayerst Laboratories, which makes several widely used contraceptive pills, said the company had “no plans to market any birth-control pill formulations for post-coital or emergency contraception.”

She said the company supported the need for American women to have contraceptive choices, but said “excessive litigation over contraceptives in America … has had a chilling effect on contraceptive research and utilization.”

The FDA’s action is its second recent ruling of major importance regarding birth control. Last year, the agency approved the use of the abortion pill, which enables a woman to terminate her pregnancy in a clinic with a special combination of drugs.

The FDA says contraceptive pills have been proven safe over the last three and a half decades. The agency noted that more than 4 million prescriptions for emergency contraception have been written in the United Kingdom since 1984.

The Kaiser Family Foundation estimates that 225,000 American women have used the technique as of last June. Doctors prescribing the technique did so “off-label” - using a drug for a condition different than the one it was approved for.

The FDA said there was “no evidence” that the drugs would “have an adverse effect on an established pregnancy.”

“The target audience is every sexually active person in the United States,” said Benshoof, who unsuccessfully petitioned the FDA in 1994 on behalf of the American Public Health Association and other groups to require companies to label the pills for emergency contraception.

xxxx This sidebar appeared with the story: HOW MUCH TO TAKE? The U.S. Food and Drug Administration’s instructions for using six brands of birth control pills as “emergency contraception” come with a warning. Whether using pills manufactured by Wyeth-Ayerst Laboratories or Berlex Laboratories, it is vital to take the proper color pill in the correct dose because birth control pills come in different colors that indicate different levels of hormones - and, in some brands, placebo pills that women take for one week each month. Women seeking to use birth control pills as “emergency contraception” should consult a physician first.

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