FDA under fire for unprecedented role of politics in Plan B decision.(News)

The Food and Drug Administration is once again under fire for its evaluation of the proposed over-the-counter use of the emergency contraceptive Plan B, with advocates for approval accusing the agency of putting politics first.

Fueling the accusations are recently released depositions from a lawsuit filed against the FDA by the Center for Reproductive Rights along with the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health, and individual members of the Morning-After Pill Conspiracy, an advocacy group. The plaintiffs are asking a U.S. District Court in New York to order the FDA to make Plan B (levonorgestrel) available without a prescription to women of all ages.

In an April deposition taken as part of the lawsuit and released in late May, Dr. Steven Galson, director of the Center for Drug Evaluation and Research, testified that he had been leaning toward approval of over-the-counter use of Plan B for older teens and women in early 2005 when Lester Crawford, Ph.D., who was then acting FDA commissioner, took over decision making on the application. "Dr. Crawford ... told me that he was concerned about where we were heading because he knew that I was heading towards this recommendation, and he told me that he was going to make the decision on what to do with the application," Dr. Galson said in his deposition.

Dr. Galson said that this was the first time that the FDA commissioner had ever removed authority over a drug application from him and he did not know of it happening to anyone else in his position. In May 2004, the FDA rejected an application from Barr Pharmaceuticals Inc. to make Plan B available without a prescription.

In August 2005, Dr. Crawford announced that the agency was issued an advance notice of proposed rule making to solicit comments about the ...