Senators to stall FDA pick over contraception

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Two Democratic senators plan to block a vote on President Bush’s pick to head the Food and Drug Administration over the agency’s stalled decision on whether to allow a “morning-after” contraceptive to be sold over the counter, one of the lawmakers said on Wednesday.

Sen. Patty Murray of Washington state said after meeting with the nominee, Lester Crawford, that he had failed to reassure her and Sen. Hillary Clinton that the agency would make a definitive decision on whether to allow sales of Barr Pharmaceuticals Inc.’s Plan B without a prescription.

"We will be putting a hold on this nomination when it goes to the (Senate) floor until a decision is reached on Plan B ... any decision,” Murray said. Sens. Clinton of New York and Edward Kennedy of Massachusetts also participated in the meeting.

The senators said last month during a hearing with Crawford, who is currently acting FDA commissioner, they wanted answers from him before the Republican-led Senate held a vote on his nomination.

The Senate Health Education Labor and Pensions Committee is expected to clear his nomination when it meets next week, but Murray and Clinton’s hold would block a full Senate vote.

Murray said Crawford indicated the FDA was concerned about legal issues involving the drug’s label and the possibility of riskier sexual behavior. “I think it’s because of their fear of litigation, not because they don’t have the scientific data,” she said of the delay.

Officials for the FDA and Barr could not immediately be reached for comment.

Plan B, an emergency contraception that may prevent pregnancy when taken within 72 hours of sexual intercourse, has taken on a political hue as both opponents and advocates of the switch from prescription to over-the-counter status have tried to pressure the FDA.

Supporters such as women’s rights groups have said easier access to Plan B would reduce the number of abortions by helping more women get the pills in time.

Conservative lawmakers and other opponents have argued wider availability would lead to more promiscuity and sexually transmitted diseases, particularly among teenagers.

Plan B, approved as a prescription in 1999, contains higher doses of one of the hormones used in birth-control pills called progestin. Women are supposed to take two tablets 12 hours apart.

Agency officials last May rejected an earlier bid by Barr to sell the drug without a prescription, despite an FDA advisory panel’s favorable recommendation.

The company filed another application limiting nonprescription sales to women 16 and older. In December another panel of outside experts voted 23-4 to recommend Plan B as a nonprescription product.

“The bottom line is that the FDA has had the Plan B application for years and the American people simply need an answer yes or no,” Clinton said in a statement.

Murray added Crawford would not give the lawmakers a date for the decision. “Soon is all I heard,” she said.

Shares of New Jersey-based Barr closed down 30 cents or less than one percent at $49.75 on Wednesday on the New York Stock Exchange

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