"Only dull people are brilliant at breakfast" -Oscar Wilde |
"The liberal soul shall be made fat, and he that watereth, shall be watered also himself." -- Proverbs 11:25 |
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Former FDA Commissioner Lester Crawford, Dr. Janet Woodcock, deputy operations commissioner, and Dr. Steven Galson, director of the FDA's drug evaluation center, are to testify in court-ordered depositions to be taken by attorneys for the Manhattan-based Center for Reproductive Rights on April 26, 27 and 28 in Washington, D.C. and Rockville, Md.
The women's group seeks to force approval of over-the-counter sales of Plan B, which can prevent pregnancy if taken within 72 hours after unprotected intercourse.
Simon Heller, one of the attorneys, plans to quiz Woodcock about a March 23, 2004, staff memo suggesting she was concerned Plan B might lead to teenage promiscuity.
The FDA is only supposed to consider the safety and efficacy of drugs.
In the memo released by the FDA during the discovery process, Dr. Curtis Rosebraugh, an agency medical officer, wrote: "As an example, she stated that we could not anticipate, or prevent extreme promiscuous behaviors such as the medication taking on an 'urban legend' status that would lead adolescents to form sex-based cults centered around the use of Plan B."
Rosebraugh indicated he found no reason to bar nonprescription sales of Plan B.
"This was the level of scientific discourse, so to speak," Heller said in a phone interview, referring to concerns attributed to Woodcock. "I find it very odd that these people who are supposed to be responsible scientists and doctors are making up wacky reasons."