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FDA allows easier access to “morning-after” pill

August 24, 2006

By Lisa Richwine

WASHINGTON (Reuters) – A “morning-after” contraceptive can
be sold to adults in the United States without a prescription,
health officials ruled on Thursday, ending a three-year fight
over wider access and use by teenagers.

The Food and Drug Administration said Barr Pharmaceuticals
Inc.’s Plan B pills must stay behind pharmacy counters to
prevent girls under 18 from getting the drug without a doctor’s
order.

Backers welcomed the decision but balked at the age limit,
saying all females needed quick access in order for the pills
to work. Two Plan B pills – sold by prescription since 1999 –
can prevent pregnancy if taken soon after intercourse.

The decision also angered conservatives, and some groups on
both sides were girding to challenge the decision in court.

FDA officials said Plan B was safe and effective for women
when taken as directed, but should not be used routinely.

Women’s groups said wider access could reduce unwanted
pregnancies and abortions. Studies show Plan B cuts the chances
of pregnancy by 89 percent if taken within 72 hours of sex. It
works best when used within 24 hours.

“There’s no scientific or medical reason” for the age
limit, said Amy Allina, program director for the National
Women’s Health Network.

Barr plans studies to back non-prescription use by a
broader age group, said company spokeswoman Carol Cox.

Conservative groups that fought wider availability said age
enforcement was impossible. They worry it could increase
promiscuity and sexually transmitted diseases, particularly
among teenagers.

The Family Research Council, a Christian lobbying group,
said the FDA overreached and it would pursue legal and
legislative options.

Women who have sued the FDA over repeated delays on Plan B
said they would fight in court to have the age limit lifted.

The FDA said women and men must show proof of age to buy
the emergency contraceptive without a prescription, and younger
girls still need a doctor’s order.

Barr agreed to monitor age enforcement and limit Plan B
distribution to health clinics and stores with pharmacies.
Nonprescription packaging should be available by year’s end.

Barr has not set a price for non-prescription Plan B, Cox
said. The prescription product now sells for about $25 to $40.

Aimee Hess, a health-care analyst at Rochdale Research,
said Plan B was a modest-sized product for Barr with estimated
annual sales of about $30 million. “Sales could double within
the next year or two, and a major emotional issue has been
dealt with,” Hess said.

Approval prompted Democratic Senators Patty Murray of
Washington and Hillary Rodham Clinton of New York to end their
objection to a Senate confirmation vote on President George W.
Bush’s pick to run the FDA, acting Commissioner Andrew von
Eschenbach.

Murray, Clinton and other Plan B supporters argued that
repeated delays since the initial application in April 2003
were triggered by politics rather than scientific concerns.

FDA approval came three days after Bush said he supported
the age limit on nonprescription sales.

“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,” White House spokeswoman Dana Perino said.

Emergency contraceptives are available without a
prescription in about 40 countries. Nine U.S. states already
allow access by those of any age through pharmacists.

Plan B pills contain higher doses of progestin, a hormone
used in prescription birth-control pills for 35 years. Women
are supposed to take the two tablets 12 hours apart.

Like prescription birth control pills, Plan B blocks the
release or fertilization of an egg. Some research suggests the
hormone also may keep a fertilized egg from attaching to the
womb, and some opponents liken that mechanism to abortion.

Plan B is different from RU-486, a pill that causes an
abortion early in pregnancy by blocking the hormone that keeps
a fertilized egg implanted in the uterus.

Barr stock closed down 20 cents at $57.77 a share on the
New York Stock Exchange on Thursday.

(Additional reporting by Susan Heavey in Washington and
Ransdell Pierson in New York)


Source: reuters



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