Morning-After Pill Sale Urged Over the Counter
A joint panel of outside experts strongly recommended Tuesday that the Food and Drug Administration make the so-called morning-after birth control pill available over the counter, saying that unhindered access to emergency contraception would dramatically reduce the number of unwanted pregnancies and the demand for abortion.
If the FDA goes along with the recommendation as anticipated, women who have had unprotected sex would be able to go to a drugstore to buy a box of Plan B, a packet of two high-dose oral contraceptives, without a prescription from a doctor or the assistance of a pharmacist. The pills, which cost from $25 to $30 a packet, could be available over the counter as soon as this spring.
Planned Parenthood hailed the recommendation as “a victory for all women and for sound public health policy,” and other supporters said final approval would represent “one of the most significant steps in decades to reduce unintended pregnancies.” The FDA approved marketing of the birth control pill in 1960.
But some religious and antiabortion groups argued Tuesday that easier access to emergency contraception would increase promiscuity and the incidence of sexually transmitted diseases.
Judie Brown, president of the American Life League Inc., said the drug “should not be available under any circumstance” because a woman taking it can “abort a child before that child implants. Human life begins at conception.”
The FDA approved Plan B as a prescription drug in 1999; another emergency contraception product was approved in 1998.
Since then, millions of women in the United States have used such drugs to prevent pregnancy. But because the first pill must be taken within 72 hours -- and preferably within 24 hours -- after unprotected intercourse, millions, potentially, of other women did not have time to see a doctor and get to a pharmacy.
California and four other states allow pharmacists to dispense the drug without a doctor’s prescription. But finding emergency contraception is “still a challenge,” said Dr. Carole Ben-Maimon, president of Barr Research, a unit of Barr Laboratories Inc., which is acquiring Plan B’s manufacturer, Women’s Capital Corp.
In California, which has spent about $1 million to advertise the “Pharmacy Access” program since it went statewide in January 2002, only 14% of pharmacies have emergency contraceptives in stock, she said.
The FDA does not have to follow an advisory panel’s recommendation, but it usually does. The agency’s decision on Plan B -- so named because it is to be used if “Plan A” fails -- is expected by late February, an FDA official said.
The United States has the highest rate of unintended pregnancies in the industrialized world -- 3 million annually. About half of those pregnancies end in abortion.
“There is a public health imperative to increasing access to emergency contraception,” Dr. Vivian M. Dickerson, president-elect of the American College of Obstetricians and Gynecologists, told the panel. “If we are truly dedicated to reducing abortions in this country, let’s prove it.”
By a joint vote of 23 to 4, the FDA’s advisory committees on nonprescription drugs and reproductive health drugs agreed. Scientific studies show that Plan B is safe and effective, but prescription-only use has greatly limited its availability, the panel members said.
“Plan B is an oral contraceptive, not an abortion pill,” Ben-Maimon said in arguing for the drug’s over-the-counter use.
The distinction is considered important, both scientifically and politically.
The so-called abortion pill, mifepristone -- also known as RU-486 -- can be used up to seven weeks after the beginning of a woman’s last menstrual period to induce a nonsurgical abortion.
The FDA approved that drug in 2000 and has since received more than 400 reports of women suffering adverse effects after having taken it.
In September, an 18-year-old Livermore woman died from an inflammation of the uterus several days after taking RU-486.
The FDA has received no reports of deaths among women who have taken the morning-after pill, agency officials said. The most common side effects of the drug are nausea, headache and fatigue.
In very rare cases, some women may experience severe abdominal pain a few weeks after taking it. If that occurs, a woman should see a doctor immediately, the joint panel agreed. If the drug was taken too late and did not prevent a pregnancy, the severe abdominal pain could be a symptom of an ectopic pregnancy, a life-threatening condition caused by the implantation of the egg in the fallopian tube rather than the uterus.
FDA scientists and others say that the pill has no effect on women who are already pregnant, but abortion opponents argue that there are no long-term studies on any children born to women who took the pill during that pregnancy.
Plan B and the other FDA-approved morning-after pill, Preven, contain higher doses of the hormones than are in regular, once-a-day birth control pills. Ben-Maimon and FDA scientists said the morning-after pill prevents pregnancy mainly in two ways.
Taken correctly, they said, the drug most often keeps a woman’s ovary from releasing an egg. If a woman has already ovulated, the drug prevents fertilization of the egg by slowing the movement of sperm toward it.
Clinical studies of more than 7,000 women who took the drug correctly showed that Plan B reduced the rate of pregnancy from unprotected sex from just over 8% to just over 1%, Ben-Maimon said. In one study, when women took the first pill within 72 hours of having unprotected sex and then took the second pill 12 hours later, the drug was 89% effective.
But the drug was shown to be even more effective when the first pill was taken earlier than 72 hours after intercourse. As a result, panel members recommended that Plan B packaging include dosing instructions encouraging women to take the first pill “immediately” or “as soon as possible.”
FDA officials and some other scientists -- as well as most antiabortion groups -- believe that the morning-after pill also can work by preventing the implantation of a fertilized egg in a woman’s uterus.
While Ben-Maimon insisted that “there is no data” to support that view, several panel members recommended that the Plan B package or the package insert include a statement indicating that the drug may act by preventing implantation in some cases.
On another matter of disagreement, a majority of panel members recommended that the Plan B contraceptive be made available to women of all ages.
“I’ve had patients 10 and 11 years old who were pregnant,” said Dr. Leslie Clapp, a pediatrician and member of the nonprescription drug committee. Taking the morning-after pill is “a safer option,” she said.
Another panelist, Dr. Alastair Wood of Vanderbilt University’s medical school, said he would encourage women to buy Plan B to have on hand in case they need emergency contraception.
The FDA prides itself on making its decision based solely on scientific evidence, and, in the end, it was the results of the clinical trials of Plan B that influenced the decision by the advisory panel Tuesday.
But the all-day hearing was also punctuated by passionate testimony on both sides of the issue.
Jill L. Stanek, a registered nurse representing the conservative group Concerned Women for America, said Plan B “would be a welcome tool for sexual predators, who could keep a stash of it in their bedrooms to give victims after each rape.”
Linda Freeman, one of several college students and other young women who traveled from New York and Florida to testify at the hearing, said making the drug more widely available was of vital importance to women’s health and independence.
“We women are aware of when we need to take the morning-after pill,” she said. “Do not insult our intelligence.”
Ben-Maimon said 53% of unintended pregnancies occur when women are using contraception. Even in those situations, a condom can break or come off, or a woman can forget to take a birth control pill, she said.
“Most of these [unprotected sex] events are not occurring from 9 to 5, Monday through Friday,” said Ben-Maimon. “They’re occurring at night and on weekends,” when doctor’s offices and pharmacies are closed.
In attempting to sell Plan B over the counter, “the intention is to try to decrease unintended pregnancies, especially teenage pregnancies,” she said.
