Saturday, May 29, 2004

Plan B Approval, Part IV

More reaction to the FDA's decision to deny OTC approval for Plan B:

Obtaining any data in those under age 14 years will be a daunting task, said Dr. David F. Archer, professor of ob.gyn. at Eastern Virginia, Medical School, Norfolk. "The government is setting up a dual standard," he said, explaining that institutional review boards are "very unhappy" to do studies in younger women.

Furthermore, women younger than age 16 who are menstruating are biologically considered adults in terms of ovarian function, and related data from women older than age 16 are applicable to those younger than age 16, he said.


In a written statement, Dr. Vivian M. Dickerson, president of the American College of Obstetricians and Gynecologists, called the FDA's failure to approve OTC status for Plan B "morally repugnant."

"This decision to ignore an advisory panel's assessment of the scientific evidence is not only rare, but it gives credence to recent criticisms that political interference is hampering scientific review within federal agencies today," Dr. Dickerson said.

Read the whole article. In addition to Plan B, it has an interesting discussion about proposed changes to birth control pills labeling. All I have to say is Kafka was nothing compared to these politicians.

UPDATE: Welcome visitors from Trish Wilson's blog, and Alas, a Blog.

ETA: Plan B Approval Part I, Part II, Part III.

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