Plan B Kerfuffle

December 9, 2011

In an unprecedented move yesterday the US Secretary of Health and Human Services, Kathleen Sebelius, invoked her authority to override the recommendations of the Food and Drug Administration (FDA) and denied approval for the Plan B “morning-after pill” contraceptive to be made available to women of any age without a prescription.

 

FDA Commissioner Margaret Hamburg, MD, issued a press release laying out her disagreement but legally mandated compliance with Sebelius’ decision, creating a rare public conflict between government officials in what is usually an arcane bureaucratic process.

 

Renee Boss, MD, MHS, a faculty member at the Johns Hopkins Berman Institute of Bioethics, said the facts support Hamburg and the FDA’s position. “Nearly half of all girls in the US report that they have had sexual intercourse by age 17, with a higher rate among girls who are depressed, abuse drugs or alcohol, have poor relationships with their parents or who have limited supervision,” Boss said.   “Of those girls under 17 who are sexually active, nearly one-third do not use any form of contraception, a number significantly higher than for older women,” she added.

 

Boss also noted the inequity of the regulation affecting only girls, and the long-lasting negative impact of a teenage pregnancy. “Boys who have unprotected sex may be able to avoid the consequences of unwanted pregnancy –girls cannot.  Girls who become pregnant as adolescents are more likely to drop out of school, to become pregnant again as adolescents, and to live in a cycle of poverty,” Boss said.

 

In her press release Sebelius cited the need for “enough evidence to show that those who use this medicine can understand the label and use the product appropriately.”  That evidence was not supplied to her satisfaction.  “The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” Sebelius said.

 

Boss, however, said there is lack of evidence that girls under 17 cannot understand the labeling.  “There are no data to support the claim that girls under 17 years old will not be able to administer the medication as directed,” Boss said.  “Plan B has been shown to be safe for girls as young as 11 years old.  Disregarding scientific evidence in the name of politics and paternalism is a practice that should not be tolerated. The $50 price tag that comes with Plan B is already a barrier enough.”

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Leah Ramsay
Renée Boss

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