The nomination of Lester M. Crawford to be commissioner of the Food and Drug Administration was put on indefinite hold yesterday by two Democratic senators to protest the administration's long delay in deciding whether to allow non-prescription sales of the emergency contraceptive Plan B.
Sen. Patty Murray (D-Wash.) announced the hold after a 30-minute meeting with Crawford yesterday that she said ended without a commitment regarding when the Plan B issue might be resolved. She said Sen. Hillary Rodham Clinton (D-N.Y.) joined her in blocking a vote on the confirmation until the FDA acts.
 
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Murray said that the administration appears to be making a "political and ideological decision" regarding Plan B, and that "there is no scientific reason for this approval to not go forward." She said the FDA's credibility as a science-based agency "is on the line."
Crawford, FDA's acting commissioner, left the meeting in Murray's office without commenting. Clinton and Sen. Edward M. Kennedy (D-Mass.) also attended the meeting.
The FDA approved emergency contraception in 1999 as a prescription-only drug. Its manufacturer, Barr Laboratories, applied for approval to sell Plan B without a prescription in April 2003, and an agency advisory panel voted 23 to 4 to support the application later that year. FDA's scientific staff also strongly recommended approval.
Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, surprised many by rejecting the application last May. The FDA was supposed to decide on a revised application in January, but it has taken no action.
The question of whether emergency contraception should be available without a prescription has become contentious -- with social conservatives saying it would encourage young women to be promiscuous and advocates of wider use saying it would prevent pregnancies that could result in abortions.
If taken within 72 hours of unprotected sex, Plan B works like a contraceptive and prevents ovulation, fertilization or implantation of a fertilized egg. The most generally accepted definition of when life begins is when a fertilized egg is implanted in the uterus, but some religious conservatives believe it happens when the egg is fertilized and consider emergency contraception a form of abortion. Most medical professionals do not.
During his confirmation hearing, Crawford appeared to say that the Plan B application would ultimately be approved, but Murray said he was unclear on that question yesterday. She said the FDA voiced two remaining concerns -- that the easier availability would effect the behavior of young women and that a lawsuit filed by advocates of Plan B against the FDA in January had made the review more complicated.
That lawsuit focuses on how the drug would be sold. Advocates want Plan B to be available on pharmacy shelves, while Barr Laboratories -- in its second submission -- proposed that it be available without a prescription but only from a pharmacist.
After the meeting, Clinton said that "the FDA has had the Plan B application for years and the American people simply need an answer, yes or no. Science should never take a back seat to politics and ideology."
