'Morning-After'
Pill Approval Prompts Mixed Reaction By Amanda Gardner HealthDay Reporter
FRIDAY, Aug. 25 (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
