By Rob Stein,
In a separate statement and letter to Hamburg, Sebelius said she overruled the FDA because she had concluded that data submitted by the company that makes the drug did not “conclusively establish” that it could be used safely by girls of all ages.
“About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius said. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
The surprising decision is a stunning blow to some doctors, health advocates, family-planning activists, members of Congress and others who backed relaxing the restrictions to help women prevent unwanted pregnancies.
“We are outraged that this administration has let politics trump science,” said Kirsten Moore of the Reproductive Health Technologies Project, a Washington-based advocacy group. “There is no rationale for this move. This is unprecedented as evidenced by the commissioner’s own letter. Unbelievable.”
Susan F. Wood of George Washington University, who resigned from the FDA in 2005 because of delays in relaxing restrictions on Plan B, said she was “beyond stunned” by the decision.
“There is no rationale that can justify HHS reaching in and overturning the FDA on the decision about this safe and effective contraception,” Wood said. “I never thought I’d see this happen again.”
Opponents had urged the agency to reject the move, saying such a decision would expose girls and women to potential risks from taking high doses of a potent hormone, interfere with parents’ ability to monitor their children and make it easier for men to prey on vulnerable minors.
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