so it has been active for quite some time.
http://nwhn.org/who-do-you-trust-womens-he... Who Do You Trust on Women's Health: Dr. Susan Wood Speaks Out to NWHN About the FDA
Women’s Health Activist Newsletter
November/December 2005
By Cindy Pearson
On August 31, 2005, Dr. Susan F. Wood resigned from her position as head of the Office of Women's Health at the Food and Drug Administration (FDA) in protest over the agency's handling of emergency contraception (EC). That month, the FDA announced that it would not approve Barr Laboratory's application to make Plan B emergency contraception available over-the-counter (OTC). In Susan's words: "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled." Susan has been busy since her resignation, talking to groups around the country about how the FDA is ignoring science and the threat this poses to women's health. Cindy Pearson, NWHN's Executive Director, caught up with Susan in Ann Arbor, Michigan, in early November. Below is a portion of their conversation.
Cindy: Susan, how did you see the process go wrong in relation to Plan B Emergency Contraception, and the request to make it available over-the-counter?
Susan: There were a couple of places where the process went wrong. First of all, in 2004, the Director for the Center for Drug Evaluation and Research overruled the decision of the scientific reviewers and the Advisory Committee's recommendation that EC be made available over-the-counter. This overruling was very unusual because there was, essentially, consensus at every level below the Director that EC should be approved for OTC use. So, for the FDA to come out with a non-approvable letter was quite unusual, given the strong agreement in favor of over-the-counter approval at every level and of the Advisory Committee.
The second way the situation was unprecedented was that the FDA asked a question about an OTC product that we've never asked before. The FDA has never asked whether a small, specific group of the general public can understand a product's label and use the product correctly. In this case, we asked about teens aged 16 and under. There is no evidence to suggest that EC is not safe and effective for these young teens, and there is no precedent for pulling them out as a special population and seeking greater restrictions on their use of a product.
http://www.washingtonpost.com/wp-dyn/conte... FDA Official Quits Over Delay on Plan B
By Marc Kaufman
Washington Post Staff Writer
Thursday, September 1, 2005
Susan F. Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, said she was leaving her position after five years because Commissioner Lester M. Crawford's announcement Friday amounted to unwarranted interference in agency decision-making.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.
~~~
Many supporters of the Plan B application -- including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) -- accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford's ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.
Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn't always yes and no. Sometimes it requires additional thought."
So, the FDA finally has turned around from Bush times, but now we have this decision coming from Sebelius at HHS
