A
Contraceptive Clears a Hurdle to Wider Access
By
GINA KOLATA, NYTimes on the Web, December 17, 2003
GAITHERSBURG, Md., Dec. 16 — In a 23-to-4 vote, two
expert advisory committees to the Food and Drug Administration
recommended Tuesday that a so-called morning-after pill to prevent
unintended pregnancies be sold over the counter.
The F.D.A. usually follows its committees' advice,
although the final decision rests with its commissioner, Dr. Mark B.
McClellan. But the overwhelming vote by the agency's outside advisers
led proponents as well as opponents to expect that Dr. McClellan would
go along with the committees, making his decision within weeks to
months.
The drug is an emergency contraceptive known as Plan B, to
be taken when regular contraception either fails or is skipped.
Consisting of two high-dose birth control pills, Plan B is meant to be
used within 72 hours after unprotected sexual intercourse and may
prevent up to 89 percent of unplanned pregnancies.
If approved, widespread availability of Plan B could have
an impact second only to the advent of the birth control pill, advocates
say. The proponents, including groups like Planned Parenthood, argued to
the panel that Plan B was safe and could prevent as many as half of the
three million unintended pregnancies in the United States each year.
Kirsten Moore, president of the Reproductive Health
Technologies Project, an advocacy group, said she was delighted but
feared that political considerations would have held more sway. "I
guess I just didn't have a lot of faith that people would let the facts
speak for themselves," Ms. Moore said.
The Bush administration is an opponent of abortion and has
been more conservative on birth control than the Clinton administration,
which in 2000 approved a pill that induces abortion in the early weeks
of pregnancy.
Opponents of the morning-after pill, including religious
groups, told panel members that over-the-counter sales could encourage
irresponsible sexual behavior. They also say that women may not
understand how this type of pill works. While it usually acts by
preventing ovulation, it also may prevent a fertilized egg from
implanting. Those who believe that pregnancy begins with fertilization
say the pills in doing this can induce abortions.
The company that will market Plan B, Barr Laboratories,
says it will provide detailed information to women on what the pills do
and on how to use them. It wants to sell the drug only in stores with
pharmacies but adds that it plans to advertise widely to women and
doctors. The prescription now sells for $25 to $35, the company said but
added that it had not decided what to charge for over-the-counter sales.
If the F.D.A. agrees, both sides say they expect enormous
medical and social consequences.
Dr. James Trussell of Princeton, a member of the advisory
committee who voted for the motion, said he had waited for years for
this day to arrive. "It's hard to believe it actually
happened," Dr. Trussell said. Allowing Plan B to be sold over the
counter, he added, "sends a signal to women that it is safe."
But Dr. W. David Hager of the University of Kentucky, one
of four committee members who voted against the motion, said he was
worried about the implications for sexual behavior. Dr. Hager said Plan
B would have a similar effect to the birth control pill, which he said
ushered in "a new day and age for the expression of sexuality among
young people."
"What we heard today was frequently about individuals
who did not want to take responsibility for their actions and wanted a
medication to relieve those consequences," Dr. Hager said. He said
he was worried in particular that it would encourage sexual activity
among adolescents, who could just buy the drug on their own.
While Plan B and a similar drug, Preven, made by Gynétics
Medical Products N.V. of Belgium, were in theory available to women by
prescription, medical experts say the drugs are underused, even in five
states that passed laws to make them easier to obtain. Those states —
Washington, California, Alaska, New Mexico and Hawaii— allow
pharmacists to provide emergency contraceptives to women without a
prescription.
Dr. Carole Ben-Maimon, the president of Barr Laboratories,
which is in the process of buying Plan B from Women's Capital
Corporation, its current owner, said that even with publicity directed
at consumers and health care professionals in California, only 14
percent of pharmacies and pharmacists in the state provide the drugs
without a prescription.
"In a state as large as California, finding emergency
contraception without a prescription is still an enormous
challenge," Dr. Ben-Maimon said. Another obstacle for women, she
said, is that they are required to talk to the pharmacists, who decide
whether emergency contraception is indicated. "In my pharmacy,
there aren't any areas where I can hold a private conversation with my
pharmacist," Dr. Ben-Maimon said.
At the meeting on Tuesday, two F.D.A. committees, the
Nonprescription Drugs Advisory Committee and the Advisory Committee for
Reproductive Health Drugs, heard evidence from F.D.A. staff members;
Barr, the company marketing the drug; and the public. The panels consist
of experts in a variety of fields, including obstetrics and gynecology,
pharmacology, pediatrics and internal medicine. They also represent a
spectrum of views on birth control.
The company provided data from studies that showed the
label to women ages 12 to 50 in shopping malls and then assessed their
comprehension. It also provided a study of more than 500 women in family
planning centers who took the drug, asking whether they followed
instructions. The studies, the company argued, indicated that women
could understand the label and take the drug as intended.
Extensive studies with contraceptives also indicate that
side effects, like nausea and vomiting, were limited and minor, the
company said, adding that it knew of no deaths.
"Women deserve access at any time, at any age, for
any reason," a young woman from the Gainesville, Fla., area chapter
of the National Organization for Women told the panel. "I braved
football-game traffic to go to the campus infirmary," she said, but
it was closed. "I had no idea where I could get it," and so,
she said, she just hoped for the best.
Opponents said the data did not convince them that the
drug was safe enough to be so freely available.
Judy Brown, president of the American Life League, said,
"The pill acts to prevent a pregnancy by aborting a child."
Ms. Brown added that while Plan B may be called emergency contraception
"the emergency in this case is a baby."
Committee members urged that the drug's actions be
described so that women understood that a fertilized egg might be
disrupted.
Others argued that for teenagers pregnancy was a far worse
alternative.
"It is
the rare adolescent that ever comes to see me before she has sex the
first time," said Dr. Abby B. Berenson, a professor of obstetrics
and gynecology at the University of Texas Medical Branch in Galveston.
"Usually that's because she hadn't planned to have it in the first
place. It just happens, usually on a Saturday night when I'm not
available."
The
F.D.A. advisory panels concerning the
"morning
after" pill heard from Kim
Gandy,
president
of the National Organization for
Women.
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