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Morning-after pill
popular but under pressure
A year after
over-the-counter approval, sales soar and critics dig in
By AP from msnbc.com
on the Web, August 23, 2007
NEW YORK, Aug 22 -- In the
year since it was approved for over-the-counter sales, the morning-after pill
has become a huge commercial success for its manufacturer, but its popularity
and solid safety record haven’t deterred critics from seeking to overturn the
milestone ruling.
The pill, marketed by Barr Pharmaceuticals Inc. as Plan B, was the focus of
bitter debate for three years. After repeated delays, the Food and Drug
Administration declared on Aug. 24, 2006 that customers 18 and older should be
able to buy it in pharmacies without a prescription.
Barr began distributing the over-the-counter version last November, and all
national pharmacy chains now stock it. The company projects that sales of
Plan B will total about $80 million for 2007, almost double the total for 2006
and up eightfold from 2004, when Barr acquired the product as a
prescription-only drug.
“Overall, we’ve been very pleased with the acceptance,” said Barr spokeswoman
Carol Cox. “The product may not be for everyone — but if you find yourself
in a position to need it, absolutely it should be available.”
Despite the booming sales, and evidence that the pill is safe if properly used,
critics remain active.
Applying political pressure
A coalition of conservative groups, including the Family Research Council and
Concerned Women for America, has filed a lawsuit in federal court in Washington
seeking to reverse the FDA ruling. The groups contend that the FDA acted
unwisely under political pressure and lacked authority to approve the same drug
for both over-the-counter and prescription-only distribution based on the user’s
age.
“Barr may be making a healthy profit, but women are paying the price,” said
Wendy Wright, president of Concerned Women for America, who believes Plan B is
less effective than its backers assert.
Barr says Plan B, a high dose of a drug found in many regular birth-control
pills, can lower the risk of pregnancy by up to 89 percent if taken within 72
hours of unprotected sex.
Since the FDA ruling, there have been extensive efforts by advocacy groups and
some politicians to ensure widespread availability of Plan B.
Several states have enacted laws to improve rape survivors’ access to the
medication in hospital emergency rooms; a similar bill has been introduced in
Congress.
Also in Congress, supporters of Plan B have introduced legislation to ensure
that women serving in the U.S. military overseas have access to the pills at
their bases. The measure’s backers say servicewomen and military doctors
often can’t obtain the medication when it’s needed.
Planned Parenthood, NARAL Pro-Choice America and their allies have campaigned
to educate women about Plan B and pressure national pharmacy chains to make it
readily available. Overall, activists are pleased with the chains’
response, but they say women continue to encounter pharmacies which refuse to
stock Plan B and individual employees who, for reasons of conscience, refuse to
sell it.
“Many women still don’t know it’s available,” said NARAL’s president, Nancy
Keenan. “There’s a lot of education that needs to be done.”
Hotly debated claims
During three years of FDA deliberations over Plan B, many claims were made
about it. Supporters said it would reduce the number of unintended
pregnancies and abortions; opponents said it would fuel teenage promiscuity
because girls under 18 could obtain it from an older person — male or female —
buying it over-the-counter on their behalf.
Thus far, there have been several studies casting doubt on all these claims —
although activists of varying views say there is a shortage of authoritative
research. Cecile Richards, president of the Planned Parenthood Federation
of America, believes Plan B will contribute to a measurable drop in unintended
pregnancies once accurate information about it spreads widely among American
women.
“We’re talking about very mainstream health care here,” Richards said.
“And yet there is a fringe group of folks in this country who seem determined to
prevent women from getting emergency contraception.”
Some critics — including Roman Catholic leaders — consider the pill tantamount
to abortion, although Barr says it has no effect on women who are already
pregnant. Catholic bishops in Connecticut protested in May when the state
legislature passed a bill requiring all hospitals, including Catholic
facilities, to offer Plan B to rape victims
Deirdre McQuade, planning director for the U.S. Conference of Catholic Bishops’
Secretariat for Pro-Life Activities, also expressed concern about pharmacy
employees, saying they should have the right to refuse to sell Plan B for
reasons of conscience. Some states have passed laws to protect this right
of refusal.
“Pregnancy is not a disease,” McQuade said. “There is no absolute duty to
dispense a non-therapeutic drug, but there is a basic civil right of
conscience.”
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