FDA grilled about Plan B contraceptive -- Newsday.com: "BY KATHLEEN KERR | Newsday Staff Writer | April 24, 2006
Attorneys for a New York women's group plan to grill Food and Drug Administration officials this week about their failure to decide whether an emergency contraceptive pill called Plan B may be sold without a prescription.
...
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." ...
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