FDA sets deadline for morning-after pill
The FDA will make a decision on switching Barr Laboratories' emergency contraceptive to OTC status by Sept. 1st.
So stated Secretary of Health and Human Services Michael Leavitt in a letter to Sen. Michael Enzi (R-Wyoming), chairman, Committee on Health, Education, Labor and Pensions.
Subsequently, democratic Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York said in a statement that they would allow a vote on the nomination of Dr. Lester Crawford as FDA commissioner.
Although the joint statement notes continuing "concerns about the lack of leadership and independent decision-making that Dr. Crawford and the FDA have shown in this case," the senators said, "As we have now received a date for decision on Plan B, we have agreed to release our hold on Dr. Crawford's nomination."
Pace, a unit of Lowe Healthcare Worldwide that already handles the professional advertising for Plan B, is set to handle consumer advertising. Barr's proprietary division, Duramed Pharmaceuticals, markets the drug.
If Barr's application is approved, the Rx-to-OTC shift for plan B (levonorgestrel) would apply only to women 16 years of age and up. Women age 15 years of age and younger would still need a prescription.
"Were looking forward to getting a decision in September," Barr spokeswoman Carol A. Cox said.
Leavitt said he wrote the status report on the proposed Plan B switch at Enzi's request. "I am not part of this decision-making process," the secretary wrote, saying that it must be made based on scientific evidence. "However, I have spoken to the FDA, and, based on the feedback I have received, the FDA will act on this application by Sept. 1, 2005."