FDA rethinks 'morning-after pill' restrictions
The Food and Drug Administration on Monday said it was ready to
engage in discussions with the maker of the "morning-after pill" that
could lead to over-the-counter sales of the controversial emergency
contraceptive to women at least 18 years old.
The shift in stance, conveyed in a letter sent to a subsidiary of
Barr Laboratories of Pomona, N.Y., stopped far short of a promise that
the agency is ready to allow nonprescription sales of the drug, which is
sold as Plan B and can prevent conception if taken within 72 hours after
unprotected sex.
But by reversing an earlier suggestion that it might lack the legal
foundation for an approval, the FDA raised hopes among the drug's
proponents that the agency's unusually glacial review of Plan B might
soon accelerate.
The letter from acting FDA commissioner Andrew von Eschenbach came on
the eve of his Senate confirmation hearing, scheduled for last week.
The timing led many of the drug's supporters, including several
members of Congress, to discount the agency's announcement as a
political ploy timed to defuse what was widely anticipated to be a
difficult interrogation.
The timing "is not a coincidence," said Sen. Hillary Rodham Clinton,
D-N.Y., who with Sen. Patty Murray, D-Wash., has promised to block a
vote on von Eschenbach's confirmation until the FDA makes a decision on
Plan B.
"I think they are slow-walking this," Clinton said on a conference
call, referring specifically to the White House and an array of
conservative social and religious groups that oppose nonprescription
sales of Plan B. "They're trying to get their nominee through the
political process." FDA spokeswoman Susan Bro said today's hearing had
indeed provided the impetus to invigorate the nearly three-year review,
but she denied the timing was disingenuous.
Rather, she said, von Eschenbach did not want a prolonged discussion
of Plan B to swamp his hopes of conveying to Congress his vision for the
agency.
"He wants to focus on what is his very ambitious agenda for this
agency and get support for moving it forward," Bro said, adding that if
upcoming talks with the manufacturer went well, approval could come
within a few weeks.
The morning-after pill is a high dose of the most common ingredient
in regular birth control pills. When taken within 72 hours of
unprotected sex, the two-pill series can lower the risk of pregnancy by
up to 89 percent.
The pills, which do not work if a woman is already pregnant, prevent
ovulation or fertilization of an egg. They also may prevent the egg from
implanting into the uterus, considered the medical definition of
pregnancy, although recent research suggests that's not likely.
Laws in nine states allow pharmacists to dispense Plan B without a
doctor's prescription under certain conditions.
Contraceptive advocates and doctors groups say easier access to Plan
B could halve the nation's 3 million annual unintended pregnancies.
Opponents say wider access to the pill could promote promiscuity.
Plan B has come to symbolize what many critics of the Bush
administration say is a wide pattern of politics trumping science.
An FDA expert advisory committee, whose advice the agency virtually
always accepts, recommended approval of over-the-counter sales of the
drug for women of any age more than two years ago.
Dozens of professional societies, including the American Medical
Association and the American Academy of Pediatrics, also came out in
favor of non-prescription sales, saying there is no evidence backing
conservatives' promiscuity claims.
Yet in an apparent break from its tradition of hewing strictly to the
science, which a recent Government Accountability Office report termed
"unusual," the agency repeatedly refused to approve the switch.
That refusal has persisted even as the manufacturer offered to
restrict sales to women at least 16 years old; require that the drug be
sold only at pharmacies and not at convenience stores or other
non-medical outlets
(Washington Post)
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Possible birth of a new era
The so-called "morning after" pill could soon be available without a
prescription.
The Food and Drug Administration is considering whether to allow
over-the-counter sales of the pill, called "Plan B" to women over 18
years old. "Plan B" is a high dose of regular birth control. When taken
within 72 hours after unprotected sex, the pill can lower the chance of
a pregnancy by nearly 90-percent.
FDA officials say they want to meet with the pill's manufacturer
within the next seven days to work on the details necessary to move
forward. Any approval would come with restrictions. Only women over 18
would be able to get the pill without a prescription. The pill would
also be kept behind the pharmacy counter.
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