Monday, March 23, 2009

FDA Lacks Credibility, Says Judge in Ruling to Allow Access to Plan B by 17-year-old Women

See also OverTheCounter Today Blog.
A federal judge today ordered FDA to allow distribution of the Plan B emergency contraceptive without a prescription to 17-year-old women.

Judge Edward R. Korman ordered the agency to rescind its restriction on nonprescription access to Plan B to women 18 years old and over because "no useful purpose would be served by continuing" to require that 17 year olds have prescriptions for the drug.

FDA must comply with the order within 30 days. In the U.S. District Court for the Eastern District of New York, Korman also directed FDA to reconsider whether to make the drug available to women of all ages without a prescription.

Korman said the requirement that the product be distributed only by pharmacists can continue.

The judge ruled on a complaint filed by the authors of a citizen petition asking FDA to make Plan B available without a prescription to 17-year-old women. The agency did not act on the 2001 petition.

Korman said "FDA is free ... to exercise its expertise and discretion regarding" disposition of the petition, but the record of the Plan B switch application "shows that FDA officials and staff both agreed that 17 year olds can use Plan B safely without a prescription."

He added that FDA's "justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility."

Will Margaret Hamburg, who was named FDA Commissioner just last week, and who -- while NYC Health Commissioner -- opposed a "morality oath" demanded by the NYC Board of Education in 1992 while the city was debating abstinence-focused sex education in schools, act swiftly on the disposition of THIS petition? Or is she not yet seated on the throne?

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