Lester M. Crawford, the commissioner of food and drugs, said in a news conference that his agency had decided that the science supported giving over-the-counter access of the drug to women 17 and older, but that the agency could not figure out how to do that from regulatory and practical standpoints without younger teenagers' obtaining the pills, too.
The application "presented us with many difficult and novel policy and regulatory issues," Dr. Crawford said.
The agency will open a 60-day comment period for advice, but the commissioner would not predict when the agency might make a final decision.
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The delay infuriated Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, who had allowed the Senate to vote last month on Dr. Crawford's nomination as commissioner only after the health and human services secretary, Michael O. Leavitt, promised that the agency would decide on Plan B by Sept 1.
"They broke their promise to Senator Murray and me, to the Congress and to the American people," said Mrs. Clinton, who described the decision as "outrageous," "disturbing" and "a wake-up call to everybody in this country."
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An agency advisory committee voted, 23 to 4, in December 2003 to approve the Barr [= Barr Laboratories, who manufacture the drug] application to sell the drug over the counter. Staff members at the agency also said the application should be approved. But the director of the agency's drug center, Dr. Steven Galson, announced in May 2004 that he had decided to override the advisory committee and the staff members and reject the application.
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Barr noted that the agency had already approved over-the-counter sales of nicotine gum only to people older than 18 and that cigarettes and alcohol were routinely sold with age restrictions.
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