The Debate Over Plan B

This story originally aired on Nov. 27, 2005.

Did the Bush White House pressure the Food and Drug Administration to block the "Morning After Pill," known as Plan B, from being sold over-the-counter at your local drug store? That question is the focus of a hearing in federal court on June 13, where birth control advocates have sued the FDA to make the drug available without a prescription.

Millions of women have used Plan B as an emergency contraceptive to prevent a pregnancy in situations like a condom break or a rape. Right now, it's only available by prescription, but because it must be taken within 72 hours, the drug's manufacturer asked FDA for permission to sell Plan B over-the-counter.

That was three years ago. And, even though the drug is considered totally safe, the FDA has repeatedly postponed a decision, including taking no action since 60 Minutes aired this story in the Fall of 2005.

Plan B's problems began when it was targeted by anti-abortion-rights groups and became part of a wider debate over whether religious beliefs are encroaching on scientific decision-making.

Correspondent Lesley Stahl reports.

"If you need it on Saturday morning, Monday morning is too late. Getting to a physician to get a prescription, getting that prescription to a pharmacy and getting it filled takes time, as we all know. Then what are you going to do?" says Wood.

That's a question a woman named Evelyn faced in 2004, when she was raped at a New York nightclub.

Evelyn, 22 at the time, was rushed to St. Vincent's hospital, the nearest emergency room.

She says the hospital did not offer her an emergency contraceptive.

"It was something that they were supposed to offer," says Evelyn's mother, Sandi. "In the situation as my daughter's, as Evelyn's situation, they were supposed to offer, you know, and let the person make the decision as to whether or not they wanted it. I didn't know that it was optional."

Sandi says she knew about a New York law that says all hospitals must offer rape victims emergency contraception like Plan B.

Sandi called the nurse who had treated Evelyn at St. Vincent's. "I said, 'Why did you not give it to her?' And she very rudely said to me, 'Well, we're a Catholic hospital. We don't do birth control.' At which point, I told them what they could do with being a Catholic hospital and their views on birth control — I'd rather not say that on the air," she recalls. "I was absolutely livid."

Because of Evelyn's case, St. Vincent's is under investigation by the state of New York. The hospital told 60 Minutes it is now complying with the law.

Evelyn finally got a prescription for Plan B, and took it 10 hours after the rape. Had she not gotten Plan B and had gotten pregnant, Evelyn says she would have had an abortion. "I'm glad that that didn't have to happen, I never had to experience that," she says.

The Catholic Church opposes Plan B not just because it's birth control, but because it considers use of Plan B to be, in Cardinal Egan of New York's words, "a chemical abortion."

But Wood says this is not an abortion pill. "There is an abortion pill called RU-486, and this is not it," she says. "An abortion pill interrupts an established pregnancy. This product is contraception. It does not interrupt an established pregnancy."

She says even if you took it and were already pregnant, it would not end the pregnancy. "The only connection this product has with abortion is that it can prevent them by preventing an unintended pregnancy," says Wood.

There is some debate about that interpretation. Most of the time, Plan B works by stopping ovulation so that a pregnancy cannot occur. In a small percentage of cases, when a woman is ovulating on the day she has unprotected sex, a fertilized egg could form. In that case, Plan B might prevent the egg from implanting in her uterus.

While most doctors do not consider that an abortion, anti-abortion-rights doctors do, such as David Hager, a gynecologist from Lexington, Ky., who won't prescribe Plan B for his own patients.

"One of the mechanisms of action can be to inhibit implantation, which means that it may act as an abortifacient," says Dr. Hager. He says abortifacient means it causes an abortion and that this medication may act to inhibit implantation.

In 2002, Dr. Hager got a call from the Bush White House asking him to serve on the FDA advisory committee charged with reviewing Plan B's over-the-counter application along with two other anti-abortion-rights physicians. But when Hager argued against Plan B at committee meetings, he didn't talk about abortion.

"I was concerned about 10, 11, 12-year-old girls buying this product," says Hager.

He raised moral questions. "I'm not in favor of promotion of a product that would increase sexual activity among teenagers," he says.

Hager speculated about an increase in sexually-transmitted diseases. "I'm saying that it is possible that with the use of Plan B the individual may put herself at greater risk," he says.

But the advisory panel reviewed 40 studies that refuted his objections and showed that Plan B does not lead to more cases of sexually transmitted disease, or more risky sexual behavior.

Even Dr. Hager admits Plan B is totally safe. The FDA says there have been no deaths, no heart attacks, no strokes and no evidence of misuse or abuse.

But he says one of his major concerns is that young women wouldn't go to their doctors if such a drug were readily available.

"If we approve this for over-the-counter sale, then what is that going to do as far as what I call access to medical care for younger adolescent women?" Hager asks.

Wood disputes that view. "Is this cutting the doctor out? Would it cut out their relationship?" she asks. "Well, in fact, I think there's strong argument that the physicians themselves want this product to be over the counter."

Wood says the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Medical Association have all endorsed making this product available over the counter. That includes pediatrics, meaning younger girls.

If Plan B is sold over the counter anyone — any age — could buy it easily in a drugstore, like cough syrup or bubble bath. A big part of this issue is whether pharmacies will stock it. What if they refuse to carry Plan B?

In a survey of drugstores in Kentucky, Dr. Hager's home state, the American Civil Liberties Union found that most pharmacies didn't carry Plan B; 83 of them said they would even refuse to order it for women with prescriptions. These include Wal-Mart, which has a nationwide policy against dispensing Plan B.

The American Civil Liberties Union got a prescription for a woman named Fran, and sent her to five pharmacies undercover. 60 Minutes went along with a hidden camera to see what would happen.

Only one pharmacy, Kmart, had Plan B in stock; another drug store offered to order it, but the pharmacist told Fran it would take several days before they could possibly get it.

Remember, it has to be taken within 72 hours.

At another store, Fran was turned down by a pharmacist who explained that she believes it's an abortion pill. "The morning after pill is after you have that fertilized egg, and that is a baby. You are not allowing it to implant. So it is considered abortive," the pharmacist said.

The next day, Fran and 60 Minutes went back to that pharmacy together and found the same pharmacist.

"Anyone can walk in off the street and we can refuse to fill a prescription," the pharmacists said. Asked whether a prescription could be refused on religious grounds, the pharmacists said, "On any grounds. Personal preference. Any reason, we can refuse to fill a prescription."

But the Kentucky state pharmacy board told 60 Minutes that pharmacists must have a professional medical reason, not simply a personal preference, to turn away a prescription for Plan B or anything else.

The pharmacy did offer birth control but the pharmacist did not consider Plan B birth control.

So, with Plan B mired in the abortion debate, the FDA advisory committee took its vote on recommending whether it should be sold over the counter.

Dr. Hager voted "no." But his colleagues on the committee rejected his arguments, voting 23 to four in favor of offering the drug over the counter.

Such a lop-sided vote should have meant the application would sail through. But then the saga of Plan B took a strange turn.

Dr. Hager says someone at the FDA — he won't say who — asked him to write a "minority report" in which he asked for more studies and more data on the use of Plan B by young girls.

A few months later something totally unexpected happened: The FDA ignored the committee's overwhelming vote and rejected the proposal to sell Plan B over the counter, citing the very concerns in Hager's report.

Some people believe Hager raised these objections because of his religious beliefs, but that's something he denies. "The religious aspect did not enter into that decision for me," he says.

But in to a speech he gave to a Christian college, he seemed to admit his role was all about religion. "God has used me to stand in the breach for the cause of the kingdom," Hager said at the time.

He was talking about Plan B.

"But I argued it from a scientific perspective. And God took that information and He used it through this minority report to influence a decision. You don't have to wave your bible to have an effect as a Christian in the public arena," Hager told the audience.

Hager says he did not mean to suggest that God wanted Plan B to fail, and that he was His instrument. "I thought that God used me, He'd used my individual gifts of, whatever, in an individual way to be able to express my opinion."

But with the speech, Hager may have fueled the fire of those who say that all he did was try to cloak religious beliefs in scientific language.

"If the idea in the population of this country is that a person can't be a person of faith and also be a person of science, I strongly disagree with that," says Hager.

Should agencies like the FDA be completely divorced from the debates that go on in society?

"Again, the question the agency has to deal with is, is it safe? And is it safe for teens? Yes, it is," says Wood. "Have we asked that question about other contraceptive methods? Are we going to label, take condoms behind the counter? Make them prescription? I don't think we should.

"I think most Americans would like to leave those decisions as private decisions, and decisions within the family," says Wood.

Plan B's manufacturer, Barr Pharmaceuticals, submitted a new application to the FDA with an age cut-off, so that girls 16 and younger would still need a prescription to get the drug. This seemed to address Hager's objections and those of the anti-abortion rights lobby.

But last August, then-FDA Commissioner Lester Crawford surprised just about everyone when he announced that the agency had postponed a decision on the new application for what could be months or years. He took the unprecedented step of overruling his own scientific staff.

"I think the Plan B decision to cut the scientists out is sort of a poster child of this concern about science and politics," says Wood.

She's talking about fears that religious forces are hijacking government decision-making. Wood was so outraged by the FDA postponement that she promptly resigned as director of the Office of Women's Health in protest.

"What I saw was the science being ignored. That the scientific and medical staff (was) being cut out of decision making," says Wood.

But since this story aired, several states have taken action on their own, pressuring pharmacies to honor Plan B prescriptions. One result: Wal-Mart, the nation's largest pharmacy chain, has reversed its long-standing policy and now carries Plan B.
By Karen Sughrue By Karen Sughrue