PLAN B PROPOSAL BACKFIRES ON FDA; OPPOSITION TO VON ESCHENBACH PERSISTS
The FDA's proposal to approve the controversial contraceptive Plan B for OTC use has inflamed critics of the agency, leading to a number of new questions about the agency's decisionmaking and the continuation of a threatened hold against Andrew von Eschenbach's nomination to be the FDA commissioner.
The agency announced July 31 that if Barr Pharmaceuticals met certain requirements regarding the age of purchasers of its Plan B (levonorgestrel) contraceptive and undertook enforcement efforts, the drug would be approved for OTC use. However, these requirements led the agency's opponents to again question whether the FDA's decisionmaking was based on morality rather than science.
While the Plan B announcement was meant to head off discussion of the issue during von Eschenbach's Aug. 1 nomination hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee, it instead led to questions about the new age limit for OTC use and the agency's requirement that Barr's subsidiary, Duramed Research, be responsible for overseeing the drug's use.
The framework calls on Duramed to change the minimum age for OTC use of Plan B to 18. The company had originally requested that women 16 years and older be able to obtain the drug OTC. A year ago the agency had said that women 17 and older could use the drug OTC, lawmakers said.
While numerous senators praised von Eschenbach as being extremely qualified to be commissioner, they argued Plan B must be addressed first for the sake of the agency's credibility. "You are caught unfortunately in a situation that gives us great pause for the future of this agency," Sen. Hillary Rodham Clinton (D-N.Y.) said. Sen. Edward Kennedy (D-Mass.) called Plan B a "test case for the FDA's integrity."
HELP committee Chairman Sen. Mike Enzi (R-Wyo.) argued that von Eschenbach needed to be confirmed to ensure the best possible protection of public health. "We need a strong leader at the FDA -- one who has a mandate to act on difficult and complex issues," Enzi said in a statement. "Without a Senate-confirmed leader, we can't expect the FDA to be as effective as it should be to protect the public health." Enzi is planning to seek a vote in committee on von Eschenbach's nomination in September, the senator said.