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September
24, 2006
VOL.
44, NO. 15Oakland,
CA
U.S. bishops’
pro-life official urges
pharmacists not to support Plan B
WASHINGTON
(CNS) -- The Food and Drug Administration’s Aug. 24 decision, with
the apparent support of President George W. Bush, to allow over-the-counter
sales of Plan B, the “morning-after pill,” to women 18 and
older defies common sense and is “completely unacceptable,”
according to a pro-life official of the U.S. Conference of Catholic Bishops.
Deirdre McQuade, director of planning and information for the bishops’
Secretariat for Pro-Life Activities, urged pharmacists “not to confuse
FDA approval with a right to access” and said they should “refuse
to stock this potent drug for distribution on demand.”
Plan B uses large doses of birth-control pills to prevent conception up
to 72 hours after unprotected sex. Over-the-counter sales of the drug
were expected to begin before the end of the year.
In its Aug. 24 announcement the FDA said that, “when used as directed,
Plan B effectively and safely prevents pregnancy.” But McQuade said
that ignores the “potentially abortifacient” effects of the
drug.
“While Plan B can prevent fertilization, the manufacturer admits
it may also prevent a newly conceived embryo from implanting and surviving
in the womb,” she said. “This is properly understood as causing
an early abortion.
“Without the benefit of a doctor’s supervision, many women
will be unaware of this abortifacient action and the other risks posed
by Plan B,” McQuade added.
The FDA said the drug would be made available “with a rigorous labeling,
packaging, education, distribution and monitoring program” called
Convenient Access, Responsible Education, or CARE.
McQuade said Plan B “is a powerful dose of the artificial hormone
levonorgestrel -- 40 times the amount found in comparable prescription-only
birth-control pills.”
“Making the more potent dosage available to women upon request simply
offends common sense, especially when the drug is not designed to treat
a disease or pathological condition,” she said.
In an Aug. 21 press conference, Bush said he supported whatever decision
is made about Plan B by Dr. Andrew von Eschenbach, acting FDA commissioner,
but added he believes the drug “ought to require a prescription
for minors.”
After the FDA decision was announced Aug. 24, White House spokeswoman
Dana Perino said the president “appreciates that the FDA did an
exhaustive review, that they recognize the critical distinction between
minors and adults and the risks a drug like this can pose.”
“The FDA made clear that it will insist on stringent conditions
and restrictions on access to reduce both health risks and opportunities
for abuse, especially to protect minors,” Perino added. “I’m
sure the FDA will follow through on that and make sure these important
conditions are established and enforced.”
The FDA announced July 31 that it would work with Duramed, a subsidiary
of Barr Pharmaceuticals that manufactures the drug marketed as Plan B,
to develop a “framework for moving emergency contraception medication
to over-the-counter status” for women 18 and older.
Barr Pharmaceuticals originally had sought approval for over-the-counter
sales of Plan B to anyone 16 or over. Then-FDA Commissioner Lester M.
Crawford announced in August 2005 that the agency would not grant such
approval and set a 60-day period for comment. Crawford resigned his post
that October.
Von Eschenbach said in a July 31 letter to Duramed that the agency had
received approximately 47,000 comments, and “we concur with the
overwhelming majority of the comments ... that it is not necessary to
engage in rule-making to resolve the novel regulatory issues raised by
your application.”
