FDA To Make Decision on Plan B Application by Sept. 1

HHS Secretary Mike Leavitt on Friday in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Health, Education, Labor and Pensions Committee, said that FDA will make a decision by Sept. 1 about whether to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, the AP/Las Vegas Sun reports (Freking, AP/Las Vegas Sun, 7/15).

In the letter, Leavitt said the decision on Plan B "rests solely with the FDA and must be made according to the scientific evidence and FDA's authority." Leavitt clarified that he is "not part of this decision-making process" and said that based on "feedback" he had received from FDA officials, the agency will rule on Barr's application by Sept. 1 (Pear, New York Times, 7/16). The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B to be sold without a doctor's prescription, and FDA in January delayed its decision on Barr's revised application, which would allow EC to be sold without a doctor's prescription to women ages 17 and older but be dispensed only with a doctor's prescription for girls ages 16 and younger.

During a confirmation hearing in March, acting FDA Commissioner Lester Crawford told the Senate health committee that FDA would approve the application "within weeks" (California Healthline, 6/18).

In response to the letter from Leavitt, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) have agreed to lift their holds on Crawford's nomination (AP/Las Vegas Sun, 7/15). Rodham Clinton and Murray in June blocked a full Senate vote on Crawford's nomination and said they would maintain the hold until FDA made a decision on Barr's Plan B application (California Healthline, 6/18).

In a joint statement, Rodham Clinton and Murray said, "It is long past time that the American people had a decision on Plan B, and the FDA has finally agreed to give women across the country what we have fought for from the beginning -- a 'yes' or 'no' decision. While we continue to have concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case, we have been clear all along that our hold on this nomination is about one thing only: the FDA's failure to provide an answer on Plan B."

Sen. Tom Coburn (R-Okla.), who had placed a hold on Crawford's nomination because of concerns about FDA failing to implement congressionally mandated labeling for condoms that clarifies the limits of their effectiveness, also has lifted his hold on Crawford's nomination, according to Coburn spokesperson John Hart (Kaufman, Washington Post, 7/16). Coburn has said current condom labels are not accurate and that the packages must specify their effectiveness in preventing pregnancy and sexually transmitted diseases (California Healthline, 6/18).

According to Hart, FDA has assured Coburn that it will implement the law requiring more accurate condom labeling (Washington Post, 7/16). However, a Senate leadership aide said there could be other senators who might place a hold on Crawford's nomination, although he did not say who or specify what their concerns might be. However, the aide said he was hopeful that a vote on Crawford's nomination will occur this week (CQ Today, 7/15).