US official defends “morning-after” pill delay
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U.S. Health and Human Services Secretary Mike Leavitt on Monday defended the Food and Drug Administration’s delayed ruling on over-the-counter access for a “morning-after” pill, saying officials never guaranteed a “yes or no” decision by this week.
On Friday, the FDA postponed a ruling on Barr Laboratories’ Plan B emergency contraception because it said officials are unsure how to enforce a prescription requirement for younger girls while easing access for women over 16.
“We did take a step forward in the process,” Leavitt said. “Sometimes action isn’t always yes and no. Sometimes it requires additional thought.”
The FDA, which is part of Leavitt’s department, called for 60 days of public comment but gave no further deadlines.
Supporters and critics of the controversial drug expected the FDA to rule by Thursday, when Leavitt and FDA Commissioner Lester Crawford said the agency would act.
“FDA made their commitment to me and I made my commitment to the senators,” Leavitt said. “The commitment was they would act. They did.”
Democratic Sens. Patty Murray of Washington and Hillary Clinton of New York, who both dropped objections over Crawford’s nomination as commissioner based on that pledge, said Leavitt was playing “word games.”
“A delay is not a decision and no amount of semantics can change that,” they said in a joint statement.
Plan B, approved as a prescription in 1999, contains higher doses of a hormone used in birth-control pills called progestin. The bid to allow over-the-counter sales has lingered for more than two years amid growing debate.
Women’s rights groups and doctors say easier access would prevent unwanted pregnancies and abortions. Religious conservatives and others charge it would trigger promiscuity and sexually transmitted diseases.
Republican Reps. Mike Pence of Indiana and Joe Pitts of Pennsylvania said Plan B should never have been approved and allowing nonprescription sales would be “irresponsible.”
Barr chairman and CEO Bruce Downey said the FDA’s action was “unexpected.” Restricting certain products from youth is already done with alcohol, tobacco and other items, he told Reuters. “I think that’s a manageable problem.”
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