From CQ.com:
HHS Secretary Mike Leavitt on Monday defended FDA’s action of indefinitely deferring a decision on Barr Laboratories’ application for nonprescription sales of its emergency contraceptive Plan B, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a “yes or no” decision, Reuters reports (Heavey, Reuters, 8/29). FDA Commissioner Lester Crawford on Friday said the agency is opening a 60-day public comment period and did not give a timetable for a final decision on Barr’s application. The agency in May 2004 issued a “not approvable” letter in response to Barr’s original application to allow Plan B — which can prevent pregnancy if taken within 72 hours of sexual intercourse — to be sold without a doctor’s prescription and in January delayed a ruling on Barr’s revised application, which would allow EC to be sold without a doctor’s prescription only to women ages 17 and older. As a result of the delay, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) in June blocked a full Senate vote on Crawford’s nomination for commissioner. However, the senators in July agreed to lift their holds after Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would act on Barr’s application by Sept. 1. Crawford at a press conference on Friday said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA “with many difficult and novel policy and regulatory issues,” including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 8/29).
Leavitt Comments, Senators’ Reaction
Leavitt on Monday said, “FDA made their commitment to me, and I made my commitment to the senators. The commitment was they would act. They did.” He added, “Sometimes action isn’t always yes and no. Sometimes it requires additional thought.” However, Rodham Clinton and Murray in a joint statement said that Leavitt was playing “word games,” adding, “A delay is not a decision, and no amount of semantics can change that” (Heavey, Reuters, 8/29). Leavitt said that in considering Barr’s application, FDA found that “the science revealed significant policy questions that needed to be dealt with.” He declined to speculate when FDA would issue a final decision on the application, CQ HealthBeat reports (Reichard, CQ HealthBeat, 8/29).
UPDATE: Steve Latham comments that: Susan F. Wood, Ph.D., Assistant
Commissioner for Women’s Health and Director, Office of Women’s
Health, announced her resignation over the Plan B issue yesterday. In
her resignation letter, she wrote: “I have spent the last 15 years
working to ensure that science informs good health policy decisions.
I can no longer serve as staff when scientific and clinical evidence,
fully evaluated and recommended for approval by the professional
staff here, has been overruled.”