Democrats Block Nomination over Morning-After Pill
By Sheryl Gat Stolberg
The New York Times
Thursday 07 April 2005
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.
http://www.truthout.org/docs_2005/040705G.shtml
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