1st Emergency Birth Control Pill Approved

The Food and Drug Administration on Wednesday approved the first emergency “morning-after pill” that prevents pregnancy when taken within 72 hours of unprotected sex.

The formula uses higher-than-normal doses of regular birth control pills. It has been known to work for more than two decades but has never been widely prescribed or promoted by the medical community in this country because of the highly charged political and emotional climate associated with birth control and abortion.

Three years ago, recognizing a need for a morning-after alternative, the FDA and several women’s reproductive health groups approached Gynetics, which makes female health products, about developing a safe alternative that was known to work and would presumably prove less controversial than the French “abortion pill,” RU-486.

“We’re not dealing with abortion, we’re dealing with pregnancy prevention,” said Roderick Mackenzie, chairman and president of Gynetics Inc. of Somerville, N.J. “How can that possibly be against anybody’s moral strategies?”

In fact, Mackenzie and women’s groups are assuming that abortion foes will be less inclined to do battle against the morning-after pill, since it works by preventing ovulation, rather than by disrupting the process after an egg has already been fertilized.

Although the FDA publicized the formula for using birth control pills as a morning-after procedure some 18 months ago, Wednesday’s action marks the first time the regimen will be packaged, labeled and marketed in the United States for this use. Gynetics will manufacture and sell the drug, known as Preven, for about $20 a dose.

Calling the news “a major milestone in women’s reproductive health,” Dr. Anita Nelson, associate professor of obstetrics and gynecology at UCLA, predicted that “nearly 50% of all abortions and unintended pregnancies in this country could be avoided” with access to this medication.

Reproductive experts have predicted that widespread availability of emergency contraception could prevent up to 3 million unintended pregnancies and 800,000 abortions annually.

“Every sexually active woman should have this kit in her medicine cabinet, and it should be in every college health clinic, rape counseling center and hospital emergency room,” said Art Caplan, director of the bioethics center at the University of Pennsylvania.

Caplan, who served as an unpaid consultant to Gynetics, called the product “one of the most significant moral advances in reproductive technology in the United States” because of the “crucial distinction” between it and such products as RU-486--which is awaiting FDA approval--that disrupt a pregnancy after fertilization.

The morning-after pills, in fact, will not work on a woman who already is pregnant. “They will not hurt the fetus or harm the pregnancy,” Mackenzie said.

The kit, which will be available by prescription by the end of this month, contains four pills with higher-than-usual doses of regular birth control medication, including progestin and estrogen.

Two pills are taken within 72 hours of unprotected sex, followed by another two pills 12 hours later. The treatment is about 75% effective in preventing pregnancy, the FDA said.

The most commonly reported side effects are nausea and/or vomiting, which can last for a few hours or several days, the agency said.

The kits also contain a pregnancy test to ensure that a woman is not already pregnant.

It is not unusual for the FDA to encourage companies to develop new drugs, particularly when it believes a medical need exists; moreover, these drugs were already licensed and known to be safe and effective.

However, many companies were reluctant at the time to promote or market birth control pills for post-sexual contraception and were nervous about possible litigation and political ramifications.

The National Right to Life Committee, one of the nation’s most vocal abortion foes, issued a rather tame reaction to the approval Wednesday, saying it takes no position on any drugs or devices “that act to prevent fertilization.”

No research has been conducted to determine whether these pills have an effect on the process of the implantation of a fertilized egg. “We have no data, but if any woman was concerned about this, I wouldn’t push this product on her,” UCLA’s Nelson said.

Furthermore, Mackenzie explained: “What most people don’t realize is that pregnancy does not occur at the moment of intercourse--a necessary fact is that there be ovulation,” he said. “It is possible that an egg could be fertilized by an intercourse that took place five or six days before the ovulation.”

In February 1997, in an attempt to gain greater public awareness of the effectiveness of birth control pills as post-sex contraception, the FDA released dosing information and brand names of existing pills already on the market as a prescription guide for physicians so they could dispense them for consumer use.

It also encouraged the manufacturers of the pills to make this information available to its customers.

But few women in the United States were aware of this option, although the practice has been widely used in Europe for years.

Planned Parenthood Federation of America, which has championed the distribution of emergency contraception in recent years, said demand in its clinics has increased fourfold “as word has spread.”

But its president, Gloria Feldt, described the increase as “just the tip of the iceberg.” Millions of women who needed it were “simply unaware that emergency contraception exists,” she said.

Feldt said the organization intends to launch a three-year national public awareness campaign to promote emergency contraception, which will be boosted by the arrival of this product.

* OK FOR TAMOXIFEN: A reluctant FDA panel urged approval of tamoxifen to prevent breast cancer. A21