WASHINGTON — Whether the federal Food and Drug Administration will hold another round of public hearings on allowing young women 16 years and older to purchase an “emergency contraceptive” without a prescription isn't known. But Janet Smith knows one thing: The proposal is “an abdication of adult responsibility.”

Smith is professor of life issues at Sacred Heart Major Seminary in Detroit and a long-time apologist for Pope Paul VI's much-maligned 1968 encyclical Humanae Vitae (On the Regulation of Birth).

Teen-agers, she said, “are in a delicate point in their reproductive growth, medically speaking, and putting all of these alien hormones in their body cannot be good for their development. Morally, adults are putting a huge stake in the hands of adolescents, when we are very careful about everything else in their lives.”

Duramed Pharmaceuticals Inc., a wholly owned subsidiary of Barr Pharmaceuticals, filed an amended application with the FDA July 22, asking that the company's Plan B emergency contraceptive pill — also known as the “morning-after pill” — be available over-the-counter to women 16 years and older.

The revised submission came after the FDA concluded May 6 that Duramed's supplemental new drug application was unacceptable because the company did not provide “adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug.”

The agency is scheduled to make a decision by mid-January 2005.

According to the FDA letter, Barr Research Inc.'s clinical study included 585 subjects. Only 29 of them were between 14 and 16 years of age, and no one was under the age of 14.

In its response to the FDA decision, Duramed submitted additional clinical information specifically for the age group, which the company says supports the safe sale and marketing of Plan B over-the-counter to women 16 and older. Duramed currently markets Plan B as a prescription-only product and, according to the FDA, the emergency contraceptive has been used safely since coming on the market in 1999.

‘Semantics Game’

Plan B consists of two pills of the drug levonorgestrel (a form of progesterone, a female hormone involved in conception), 0.75 milligrams each. Duramed recommends that the first tablet be taken as soon as possible within 72 hours of intercourse and the second pill 12 hours later.

According to Duramed, the regime works essentially by preventing ovulation or fertilization. If fertilization occurs, the drug may prevent a fertilized egg from attaching to the womb. If the fertilized egg is implanted prior to a woman taking the contraceptive, Plan B will not work. In that way, Duramed says that Plan B does not cause abortion, as pro-life critics charge.

A “fertilized egg,” however, is actually an embryo, a child in the first eight weeks of conception — a unique boy or girl with his or her own DNA, life expectancy and right to life.

Cathy Cleaver Ruse, director of planning and information for the U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities, maintains that supporters of Plan B would argue that pregnancy begins at implantation and not at conception or fertilization. “It has become a game of semantics, unfortunately,” she said. “Their drugs do not interrupt a pregnancy that is under way after the point of implantation. Many medical texts today go with the new — and what I say is ‘politicized’ — definition of pregnancy which ignores the first 10 days of human life.”

Ruse also said the pill has been associated with an increased risk of ectopic pregnancy. Some of the side effects that the company warns of — such as nausea and abdominal pain — also are symptoms of ectopic pregnancy and women who take Plan B may think their reactions are normal, she said.

Making the morning-after pill more easily available also concerns Dr. Gene Rudd, associate executive director of the Christian Medical & Dental Associations and an ob/gyn clinician.

“Every drug you take into your body has some potential side effects,” he said. Those of levonorgestrel “are probably not significant, in terms of direct physical harm to the individual who is taking them unless — and we don't know this — there is significant repeated use.

“We feel comfortable that pregnancies that inadvertently get exposed to birth control pills don't seem to have any short- or long-term side effects,” he said. “You're talking about considerably more progesterone hormone in morning-after pills. If someone is in an early pregnancy and takes one regimen and then decides a few days later that she needs another one, we don't know what the five-, 10- or 15-year impact is on that unborn life.”

Missing Element

Those in favor of lowering the bar for Plan B say women need faster access to the drug, especially in situations such as a weekend sexual encounter when doctors may not be available. Rudd's primary concern is that women who have prescriptionless access to Plan B would be less likely to see their physicians, especially since the leading reason young women see a doctor is for advice related to reproduction.

“My No. 1 concern is that we are removing the patient from their very best chance to get health care and protect their mental health and physical health, in terms of their sexuality,” Rudd said.

Rudd also cited a recent study from the University of North Carolina and the Kaiser Family Foundation, which surveyed 500 young people between 15 and 17. The report found that while the majority of respondents were familiar with birth control pills, more than one in four of that majority didn't know that oral contraceptives offer no protection against sexually transmitted diseases.

By making Plan B available overthe- counter, he adds, “we're pouring kerosene on the fire.”

Whether the availability of Plan B will alter teens' sexual activity will be up for debate. Dr. David Grimes, vice president of biomedical affairs at the North Carolina-based Family Health International, cites recent research — three randomized, controlled trials and one non-randomized controlled trial, all conducted within the past four years — that addresses the potential impact of providing teens with easy access to advanced pregnancy prevention.

“All of (the trials) are in concert that there is no adverse effect and that it does not promote risky sexual behavior. To suggest that it does, I think, is derogatory to women,” Grimes said. “Rarely in clinical medicine do we have an important question in which we have quick, rapid, high-quality responses to lay that issue to rest.”

Grimes also is critical of the FDA's May decision to postpone its ruling on Barr's over-the-counter proposal. He asserts that the regulatory agency ignored the favorable recommendations of its advisory committees — including a 23-4 vote in favor of the over-thecounter proposal — and succumbed to political considerations, rather than heeding the medical evidence.

“The science is clear and incontrovertible,” Grimes said. “No one woman anywhere in the world has ever been seriously hurt or killed by this product.”

Grimes said the same cannot be said for aspirin, which is available over-the-counter to anyone — including children — who can potentially buy a lethal quantity of aspirin with no questions asked. “So, why did the FDA hold this medicine to a different standard?” he asked. “Why? Because it relates to sex, and it relates to women.”

But Janet Smith said that if a family is facing a possible pregnancy, part of the responsibility is accepting the consequences of one's actions, and abortion is “never the right thing to do.” Adoption or raising the newborn within the family are the most appropriate options.

The over-the-counter proposal is “off balance,” she said. “Girls need their parents' permission to get their ears pierced,” but now can get abortions and emergency contraceptives without their parents' permission: “What's wrong with this picture?”

Wayne Forrest writes from Providence, R.I.