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FDA rethinks 'morning-after pill' restrictions
BY RICK WEISS Washington Post
http://www.twincities.com/mld/twincities/living/15169164.htm
WASHINGTON — 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 Monday 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 this morning.
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; and be kept behind a pharmacy counter so purchasers would have to ask for it and show proof of age. The company also proposed a plan to ensure that pharmacies enforced those rules.
In Monday's letter to Barr — which the agency quickly made public on it Web site — von Eschenbach said the new willingness to consider approval was the result of the agency's request last August for public comments on the issue. At the time, the FDA raised the question of whether it might have to go through a formal rule-making process in order to grant an approval that required consumers to show proof of age.
The agency got about 47,000 comments, the letter said, with "the overwhelming majority" arguing that no new regulation was needed.
However, the FDA held out the possibility it could keep Plan B prescription-only if Barr's plan to restrict over-the-counter sales to adult women wasn't "sufficiently rigorous," von Eschenbach wrote the company.
This report includes information from the Associated Press.
BY RICK WEISS Washington Post
http://www.twincities.com/mld/twincities/living/15169164.htm
WASHINGTON — 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 Monday 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 this morning.
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; and be kept behind a pharmacy counter so purchasers would have to ask for it and show proof of age. The company also proposed a plan to ensure that pharmacies enforced those rules.
In Monday's letter to Barr — which the agency quickly made public on it Web site — von Eschenbach said the new willingness to consider approval was the result of the agency's request last August for public comments on the issue. At the time, the FDA raised the question of whether it might have to go through a formal rule-making process in order to grant an approval that required consumers to show proof of age.
The agency got about 47,000 comments, the letter said, with "the overwhelming majority" arguing that no new regulation was needed.
However, the FDA held out the possibility it could keep Plan B prescription-only if Barr's plan to restrict over-the-counter sales to adult women wasn't "sufficiently rigorous," von Eschenbach wrote the company.
This report includes information from the Associated Press.
