'Morning-After'
Pill Approval Prompts Mixed Reaction.
By Amanda Gardner, HealthDay Reporter, Friday, Aug. 25, 2006
(HealthDay News)
The U.S.
Food and Drug Administration's approval of over-the-counter
sales of the emergency contraceptive Plan B, sometimes called
the "morning-after" pill, has been met with mixed reaction.
After a
three-year delay, the approval Thursday came with stiff restrictions:
Women under the age of 18 cannot purchase the pills without
a doctor's prescription, a condition set to respond to conservative
groups' concerns that the contraceptive's easy availability
would encourage premarital sex.
"Our assessment
is that this younger age group would strongly benefit from consultation
with a health-care provider before using the product," Dr. Steven
Galson, director of the FDA's Center for Drug Evaluation and
Research, said during a news conference Thursday. "The application
did not contain enough information about this age group to make
us comfortable to do the switch fully for those younger people."
The drug
can only be dispensed over-the-counter by a licensed pharmacist
from a pharmacy.
The age
restriction is meant to ease concerns for pharmacists as well,
Galson said. "We have all kinds of restrictions that click in
at 18," he said. "We thought for this program to practically
work, the age 18 made sense. We have heard feedback from pharmaceutical
groups that the proliferation of other restrictions was going
to make it difficult for them to keep it straight. We thought
this had the greatest chance of working successfully."
Reaction
from groups that have been advocating for the over-the-counter
sale of this contraception was swift in coming. "The American
Society for Reproductive Medicine [ASRM] is pleased that FDA
has approved making emergency contraception available to women
aged 18 and over," ASRM President Dr. Joseph S. Sanfilippo said
in a statement released Thursday morning.
"We are
encouraged that FDA has heeded the advice of its Reproductive
Health Drugs Advisory Committee and the Over-the-Counter Advisory
Committee, and has recognized that the morning-after pill is
a safe and effective way to protect against pregnancy in an
emergency. ASRM has, from the beginning, advocated for the over-the-counter
availability of Plan B and has taken every opportunity to comment
to [the] FDA in writing and through its representatives."
But other
supporters of Plan B, such as Planned Parenthood, said the FDA's
decision to require age restrictions will hamper efforts to
reduce the nation's 3 million annual unplanned pregnancies,
and, by extension, the number of abortions.
"While we
are glad to know the FDA finally ended its foot-dragging on
this issue, Planned Parenthood is troubled by the scientifically
baseless restriction imposed on teenagers," Planned Parenthood
President Cecile Richards told the Associated Press. "The U.S.
has one of the highest rates of teen pregnancy in the Western
world. Anything that makes it harder for teenagers to avoid
unintended pregnancy is bad medicine and bad public policy."
Conversely,
Plan B opponents fear that the condition to require a doctor's
prescription for young women under 18 will do little to limit
teen promiscuity, the AP said.
"If the
FDA thinks that enacting an age restriction will work, or that
the drug company will enforce it ... then they are living in
a dream world," said Wendy Wright, president of Concerned Women
for America, which led the opposition to the contraceptive.
According
to Galson, the FDA approval "concludes an extensive process
that included getting expert advice from two of the FDA's advisory
committees, and an opportunity for public comment. Duramed's
[the company that will be marketing the drug] application raised
novel issues regarding simultaneously marketing both prescription
and non-prescription drugs. The FDA remains committed to a careful
and rigorous scientific process."
Both over-the-counter
and prescription versions of Plan B will be sold in a single
package.
"It's up
to the company as to when they can get the packaging and labeling
done," Galson said. "The new packaging will have to be available
before the drug can be sold."
The controversy
over the morning-after pill has been particularly heated during
the past year, after the FDA announced it would delay any decision
on the matter, despite the fact that two FDA advisory committees
had concluded the product was safe enough to sell over the counter.
The FDA
originally approved Plan B as a prescription drug in 1999. In
2001, more than 60 health groups petitioned the U.S. government
to make emergency contraceptives available without a prescription
and, in December 2003, the FDA advisory committees concluded
that Plan B was both effective and safe. They overwhelmingly
recommended that the agency make Plan B available without a
prescription.
But in an
unusual move, the FDA ignored the advice of the committees,
and instead told drug maker Barr Pharmaceuticals it was delaying
its decision. Soon after, the FDA added another condition by
informing Barr that the drug couldn't be sold over-the-counter
until more studies were done. At the time, the FDA denied that
the move was politically motivated but said that it arose from
concern that teen girls would not be able to use the product
safely.
The pro-choice
Center for Reproductive Rights had sued the FDA to allow over-the-counter
sales of Plan B, and recently subpoenaed White House e-mails
and other documents on the matter. Plan B is an extra high dose
of regular birth control that needs to be taken within 72 hours
of unprotected intercourse to be effective. Essentially, the
drug prevents pregnancy by delaying ovulation. It does not interrupt
an already implanted pregnancy.
"Emergency
contraception is a method of preventing pregnancy after contraceptive
fails or after unprotected sex," Galson said. "Plan B acts primarily
by stopping the release of an egg from the ovary. It's important
to note that Plan B is not intended for routine use.
It's an
emergency contraception." The FDA's decision on Plan B could
also end the stalemate over President Bush's nomination of Dr.
Andrew von Eschenbach to head the agency.
Sens. Hillary
Rodham Clinton, (D) -N.Y., and Patty Murray, (D) -Wash., said
Thursday that they would lift their block on the nomination,
making it likely von Eschenbach will win confirmation as FDA
chief, possibly as early as next month, the AP said. More information
For more on Plan B, visit the FDA.
SOURCES:
Aug. 24, 2006, news conference with Steven Galson, M.D., director,
FDA Center for Drug Evaluation and Research; Aug. 24, 2006,
statement, American Society for Reproductive Medicine
