Reject FDA bid to make drug available to young teens.
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The Health and Human Services Department has rejected a bid by the FDA to make the over-the-counter, morning-after pill available to young teenage girls. In a statement acknowledging HHS’s rejection, FDA administrator Margaret Hamburg argued that “there is … science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” In a separate statement, HHS explained that it turned down the proposal because data submitted by the FDA did not “conclusively establish” that the emergency contraceptive could be used safely by girls of any age. The decision came as a surprise to many doctors, health advocates, and members of Congress who had backed relaxing restrictions to prevent unwanted pregnancies.
