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New York Times, April 7, 2005
Democrats Block
Nomination Over Morning-After Pill
Author : Sheryl Gay Stolberg
DATELINE: WASHINGTON, April 6
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.
<< New York Times -- 4/7/05 >>
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