Selling the Morning After Pill Over the Counter-----

I feel there are strong arguments on both sides of this issue.

"Because taking emergency contraception is time sensitive, it is important for women to be able to have access to it 24 hours a day seven days a week," Gloria Feldt, president of the Planned Parenthood Federation of America, said. "If every woman of reproductive age had access to it when she needs it, we could prevent half the unintended pregnancies and half the abortions."

Opponents say the over-the-counter rule would be an invitation to medical nightmares, with some people, particularly teenagers, using the pills repeatedly and not telling anyone even if they have complications. The safety of repeated use has not been well studied.

But it does bother opponents, whose safety arguments are joined by moral concerns. Opponents fear that women and teenagers may end up repeatedly using the drugs without doctors' supervision and without being monitored for the known risks of birth control pills.

Debate on Selling Morning-After Pill Over the Counter

By GINA KOLATA The New York Times

Two panels for the Food and Drug Administration will consider early next week whether to allow the so-called morning-after pill, now a prescription drug taken after intercourse to prevent pregnancy, to be sold over the counter.

But unlike other more ordinary hearings for drugs like allergy medications to be shifted from prescriptions, this hearing has become entangled in the thorny politics of abortion, raising questions of when a pregnancy begins and who decides.

If approved, the drug would be the first emergency contraceptive sold over the counter. Known as Plan B when Plan A, for contraception, fails or is skipped the drug would not only be sold in drugstores, but could also be as available as aspirin, on supermarket shelves or in convenience stores or gasoline stations. The drug, essentially two high-dose birth control pills, can prevent up to 89 percent of unwanted pregnancies if taken within 72 hours of unprotected intercourse. But the sooner it is taken, the more effective it is.

It is uncertain how the panels will vote after their joint hearing on Tuesday or whether the F.D.A. will take their advice. The Bush administration opposes abortion and is far more conservative on birth control issues than the Clinton administration, which in 2000 approved mifepristone, or RU-486, a pill that induces abortion in the first few weeks of pregnancy.

Although the panels include abortion opponents like Dr. Joseph B. Stanford of the University of Utah, who has said he does not prescribe hormonal contraception, they also include one of the staunchest advocates of emergency contraception, Dr. James Trussell of Princeton.

On both sides of the issue, letter-writing campaigns to the agency, as well as e-mail campaigns to rally support, have intensified. The agency is allotting individuals and groups a few minutes each to speak.

Proponents say over-the-counter approval would make the pills easy to obtain. Many women still do not know about them, and those who do usually do not have prescriptions if they need it.

Opponents say the over-the-counter rule would be an invitation to medical nightmares, with some people, particularly teenagers, using the pills repeatedly and not telling anyone even if they have complications. The safety of repeated use has not been well studied.

Also, opponents say, women opposed to abortion who believe that pregnancy begins at fertilization may not realize they may be preventing an egg from implanting.

Among the groups in favor of selling the pills without prescriptions are the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American Academy of Pediatrics and Planned Parenthood.


Opponents include the United States Conference of Catholic Bishops, Concerned Women for America and 44 members of Congress, including the House majority leader, Tom DeLay, who asked the members of the F.D.A. advisory committee to vote no on the over-the-counter application. One large anti-abortion group, the National Right to Life Committee, has not taken a position.

Emergency contraceptives like Plan B are sold over the counter in Norway and Sweden, said Dr. Trussell, director of the Office of Population Research at Princeton. In about 30 other countries, including France and Britain, pharmacists sell the pills without prescriptions, in a category between prescription and over the counter. In Alaska, California, Hawaii, New Mexico and Washington, women can buy the pills in a similar way.

Individual states can allow sales by pharmacists, but the drug agency cannot, said Richard Merrill, a law professor at the University of Virginia who is a former chief counsel at the agency. "Drugs are either prescription or over the counter," he said.

The reason the agency is considering making Plan B over the counter is that its manufacturer, the Women's Capital Corporation of Washington, applied in the spring for the change. Another company, Gynétics Medical Products N.V. of Achel, Belgium, also makes a morning-after pill, Preven. Its chief executive, Norman Proulx, said he would decide whether to seek over-the-counter status depending on the Plan B case.

The advisory panels will also review research and hear experts on whether Plan B meets the over-the-counter criteria. They include can patients decide for themselves whether to take it? Can they use it properly? Are its side effects relatively minor and self-limited? Proponents argue that studies show conclusively Plan B's safety.

"Because taking emergency contraception is time sensitive, it is important for women to be able to have access to it 24 hours a day seven days a week," Gloria Feldt, president of the Planned Parenthood Federation of America, said. "If every woman of reproductive age had access to it when she needs it, we could prevent half the unintended pregnancies and half the abortions."

Women's Capital is selling Plan B to Barr Laboratories of Woodcliff Lake, N.J. The president of Barr, Dr. Carole Ben-Maimon, said it favored over-the-counter status.

The Women's Capital chairwoman, Dr. Ellen Chesler, said, "There is one issue in a switch, and that is safety." Plan B, Dr. Chesler added, is safe. "From a moral standpoint," she said, "I don't think it should bother anybody."

But it does bother opponents, whose safety arguments are joined by moral concerns. Opponents fear that women and teenagers may end up repeatedly using the drugs without doctors' supervision and without being monitored for the known risks of birth control pills.

Dr. Wendy Wright, policy director for Concerned Women for America, said a recent death of a California teenager who took RU-486 without telling her parents or without further medical supervision, showed that teenagers could take major risks when they feared pregnancy. The main moral concern, opponents said, is that they do not consider the drug simply as a contraceptive. It has several actions that prevent ovulation, fertilization and a fertilized egg's being implanted in a uterus. The opponents say that life begins when an egg is fertilized and that the pill can, in fact, abort a life.

"When it comes to contraception as a policy issue access, availability the Catholic bishops do not get involved in that debate," a spokeswoman for the bishops, Cathy Cleaver Ruse, said. "But when it comes to abortion, that's a different matter. It's far greater than just a religious issue. It's a human rights issue."

The drug agency has a policy when pregnancy begins, said William Vodra, an expert on drug law at Arnold & Porter, the Washington law firm. The policy dates from the 1970's, when Mr. Vodra was at the agency and considered special informed consents for pregnant women in clinical trials. The agency asked how to tell when a woman is pregnant, but there is no effective pregnancy test before implantation. It has been the policy, Mr. Vodra said, that pregnancy begins at implantation.

The final decision will be up to Food and Drug Commissioner Mark B. McClellan.

"We told him that women were counting on him to use his leadership to keep the agency on track and make decisions based on science," Cindy Pearson of the National Women's Health Network said. "He said, of course, he understood. He was committed to science. He, of course, was noncommittal on any issue. But he was engaging and personable and relaxed and friendly and open. We never got any, `I wish I didn't have to listen to you' vibes."

 

I'm surprised this will be approved so easily.

The 23-4 vote came after the advisers heard presentations from health experts, the companies and public testimony from both supporters and opponents of making Plan B easier to obtain.

The final decision will be taken by the Food and Drug Administration but the FDA usually follows the advice of its advisory panels.


FDA Panel Backs Easier Access to Morning-After Pill

By Lisa Richwine

GAITHERSBURG, Md. (Reuters) - A U.S. advisory panel on Tuesday voted to recommend allowing the Plan B "morning after" contraceptive pill to be sold without a prescription.

The final decision will be taken by the Food and Drug Administration but the FDA usually follows the advice of its advisory panels.

The pill, made by privately-held Women's Capital Corp., is intended for use by women within 72 hours after sexual intercourse to prevent pregnancy. Women's Capital is in the process of selling Plan B to Barr Laboratories Inc. .

The 23-4 vote came after the advisers heard presentations from health experts, the companies and public testimony from both supporters and opponents of making Plan B easier to obtain.

Opponents argued that women and teenage girls would rely on Plan B and abandon regular contraceptives. If women think they don't need to use condoms, they would risk acquiring sexually transmitted diseases, some opponents said.

"Over-the-counter availability of the morning-after pill will lead to increased promiscuity and its attendant physical and psychological damage," Robert Carroll, a retired physician from Pittsburgh, told the panel.

Others spoke against Plan B because they view emergency contraceptives as equivalent to abortion. Some research suggests the pills prevent implantation of a fertilized egg.


SECOND CHANCE

But supporters argued it should be made available over the counter to give women a second chance to prevent an unwanted pregnancy.

"If we are truly dedicated to lowering the number of unintended pregnancies and abortions in this country, let's prove it by making Plan B emergency contraception available over the counter," said Dr. Vivian Dickerson, president-elect of the American College of Obstetricians and Gynecologists.

Reviews by FDA staffers found Plan B's safety risks were "very limited" and posed no clear danger to a fetus if a woman was already pregnant, FDA reviewer Dan Davis said.

The FDA, headed by a Bush administration appointee, is facing political pressure to keep the morning-after pill as a prescription-only product.

Forty-four members of Congress wrote to the FDA last week saying that sale without a prescription would make Plan B "as accessible to our nation's teenage daughters as aspirin or hairspray."

FDA Commissioner Mark McClellan said the agency was getting lots of input into the decision from various groups but said the decision would be based on science.

"It's a very science-based process and that is what drives our decisions," McClellan told reporters after speaking at a briefing on the administration's efforts to combat influenza.