WASHINGTON -- President Bush's nominee to lead the Food and Drug Administration is being blocked from Senate confirmation by two Democrats who said Wednesday that they would hold up a vote until the agency settled the long-delayed question of whether an emergency contraceptive could be sold over the counter.
The Democrats, Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, met with the nominee, Dr. Lester M. Crawford, on Wednesday to discuss what they regard as foot-dragging on the issue of the so-called morning-after pill. An expert panel of scientists recommended over-the-counter sales in December 2003, but the agency has yet to issue a final ruling.
"I'm prepared to hold it for as long as it takes to get a decision made," Mrs. Clinton said. She added, "From everything we're able to determine, the agency has substituted politics and ideology for science and facts."
Dr. Crawford could not be reached, and an agency spokeswoman, Kathleen Quinn, said the F.D.A. would have no comment. But at a hearing last month, Dr. Crawford told senators the decision on the contraceptive "will not be based on politics." He did not say then when a final decision would be made and, Ms. Murray said, did not do so on Wednesday.
"It was very frustrating and very unsatisfactory," she said, adding, "I did not get any timeline at all for a decision, and there was no new information."
The hold complicates the future of the food and drug agency at a time when it is already being criticized for its handling of several drug safety scandals.
The White House had hoped Dr. Crawford, who is the acting commissioner of the agency, would help tamp some of that criticism.
"Dr. Les Crawford is a well-qualified candidate," a White House spokeswoman, Erin Healy, said Wednesday, adding that the Bush administration "will continue to work with the Senate to ensure his confirmation."
But ever since his nomination in February, Dr. Crawford has been confronted with questions not only about the safety scandals, but also about the emergency contraceptive, also known as Plan B. The senior Democrat on the Senate Health, Education, Labor and Pensions Committee, Senator Edward M. Kennedy of Massachusetts, has also raised questions about the morning-after pill.
Mr. Kennedy, who attended Wednesday's meeting, has decided against putting a hold on Dr. Crawford's nomination, a spokeswoman said. But the spokeswoman, Laura Capps, said Mr. Kennedy "conveyed today that he is hopeful that the F.D.A. will do the right thing and make a decision on this product, and until it is settled he believes it's doubtful that Dr. Crawford can be confirmed."
Though Senators Clinton and Murray believe the drug should be made available over the counter, both said that their interest was solely in getting a decision from the F.D.A. and that they would remove the hold regardless of the outcome.
Plan B, manufactured by Barr Laboratories, was approved for use by prescription in June 1999. Consisting of two pills, it is intended to be taken in the 72 hours after unprotected sex, either when regular contraception fails or is skipped. But advocates for women's health say selling it by prescription hampers its usefulness, because it is difficult for women to see their doctors quickly enough to get a prescription.
Opponents of the pill, including religious conservatives, have said it will encourage sexual promiscuity. But in December 2003, two committees of expert advisers to the food and drug agency, meeting jointly, voted 23 to 4 to recommend over-the-counter sales. The agency typically follows the advice of its expert advisers, but the decision has been delayed on several occasions.
More recently, Barr Laboratories has applied to sell the pill "behind the counter"; women seeking to buy it would have to prove they are 16 or older while those under 16 would need a prescription. The agency was supposed to issue a decision on that in January, but missed a deadline.
At last month's hearing, before the Senate health committee, Dr. Crawford said missing such deadlines was unusual. Asked when the new decision would be issued, he said: "I wouldn't want to say days. I would say weeks." But he said he could not guarantee a decision before April 13, when the committee is expected to vote on his nomination.
Copyright 2005 The New York Times Company