The director of the Food and Drug Administration's office of women's health resigned yesterday to protest the agency's decision last week to further delay approving over-the-counter sales of the morning-after pill.
"I feel very strongly that this shouldn't be about abortion politics," the director, Dr. Susan F. Wood, who is an assistant F.D.A. commissioner, said in a telephone interview. "This is a way to prevent unwanted pregnancy and thereby prevent abortion. This should be something that we should all agree on."
In an e-mail message to staff members, Dr. Wood wrote that she could no longer serve at the agency "when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
In the interview, Dr. Wood said that she "doesn't find persuasive" the explanations offered Friday by the commissioner of food and drugs, Lester M. Crawford, to justify the agency's decision regarding the morning-after pill, known as Plan B. And she said the agency was unlikely to make a decision on the Plan B application "in the foreseeable future."
Agency staff members are glum, Dr. Wood said, about Dr. Crawford's decision and openly worry that it will severely damage the agency's credibility.
Susan Cruzan, an agency spokeswoman, said Dr. Wood's decision to resign was "unfortunate as we work toward solving the complex policy and regulatory issues related to Plan B."
In a hastily convened news conference Friday afternoon, Dr. Crawford announced that the agency would indefinitely delay deciding whether to allow over-the-counter sales of Plan B because the agency could not figure out how to ensure that only women 17 and older were able to buy it and because the application presented unique challenges in making rules.
Dr. Crawford's decision was highly unusual. An advisory committee, the agency's regulatory staff and even the head of the agency's drug center had recommended that the application, submitted by Plan B's maker, Barr Laboratories, be approved. The commissioner almost never over-rules this kind of collective recommendation.
Although agency officials have repeatedly said that their decisions on the Plan B application have been driven by science, many longtime observers of the agency say the decisions were politically motivated.
Whether to allow easy access to the morning-after pill has become the latest touchstone in the nation's abortion debate. Eight states allow over-the-counter sales of the pill, but two moderate Republican governors, George E. Pataki in New York and Mitt Romney in Massachusetts, recently vetoed bills that would have added their states to that list.
Most observers say the vetoes were intended to burnish the conservative credentials of the two governors ahead of possible presidential campaigns in 2008.
Senators Hillary Rodham Clinton of New York and Patty Murray of Washington, both Democrats, released a combined statement yesterday, saying that Dr. Wood's resignation was "just the latest in a long list of examples of the Bush administration suppressing science when it doesn't fit their political agenda."
The two senators had prevented the Senate from voting on Dr. Crawford's nomination to become commissioner because they said they wanted the agency to make a decision - for or against - on the Plan B application. They lifted their holds when the health and human services secretary, Michael O. Leavitt, guaranteed that the agency would act on the application by Sept. 1.
The senators cried foul when the agency's action amounted to further delay, with Ms. Murray calling the decision "the worst double-cross I've ever seen in my time in the Senate." A spokeswoman for Mr. Leavitt said that he believed that the agency's announcement amounted to "an action."
The two senators have asked Senator Michael B. Enzi, a Wyoming Republican who leads the Health, Education, Labor and Pensions Committee, to hold a hearing on Plan B. Craig Orfield, a spokesman for Mr. Enzi, said the senator was considering the request.
Carole Cox, a Barr spokeswoman, said the company had no comment.
The material in this post is distributed without profit to those
who have expressed a prior interest in receiving the included
information for research and educational purposes.
For more information go to:
If you wish to use copyrighted material from this email for
purposes that go beyond 'fair use', you must obtain permission
from the copyright owner.