PLAN B FRAMEWORK NOT LIKELY TO SPEED VON ESCHENBACH NOMINATION
The FDA, in a move that mirrors a promise the agency made during former Commissioner Lester Crawford's nomination hearing, is pledging to decide within weeks whether to allow OTC sales of the controversial contraceptive Plan B.
However, the move seems unlikely to sway critics. Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) are still pledging to hold up the administration's nomination of Andrew von Eschenbach to be commissioner, the senators said in a release.
The FDA announced July 31, the day before von Eschenbach's confirmation hearing, the framework for approving Barr Laboratories' contraceptive Plan B for OTC use. The plan sets restrictions on the use of the drug and requires strict oversight by the company. The FDA also decided that its decision would not require formal rulemaking, a step that can take several years.
"The agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks," the FDA said in a statement. The agency is calling for an immediate meeting between it and Duramed Research, a Barr subsidiary.
However, the agency made the same pledge in 2005 right before Crawford's hearing, leaving some lawmakers skeptical of the FDA's motives. "Today's announcement is nothing more than another delay tactic. The FDA continues to shirk its duty to serve as an independent agency dedicated to no other goal than the promotion of sound science and the well-being of the American people," Clinton and Murray said. "We will maintain our hold on Dr. von Eschenbach's nomination until a decision is made."
The Center for Reproductive Rights (CRR), which is suing the FDA over the delayed Plan B decision, also questioned both the timing and the sincerity of the announcement. "While we hope the FDA has finally decided to stop playing politics with Plan B, we remain skeptical, especially given the new requirements the FDA is placing on Barr Pharmaceuticals in order to obtain approval," CRR President Nancy Northup said. "We believe that by imposing these additional hurdles the FDA will continue to violate the constitutional rights of women in need of emergency contraception."
The letter from the FDA to Duramed is available at www.fda.gov/oc/planb/duramed073106.html (http://www.fda.gov/oc/planb/duramed073106.html).