Wednesday, 7 December 2011
Plan B ruling: FDA overruled by Obama administration
The federal government
Wednesday rejected a request
to let young teenage girls buy
the controversial morning-after
pill Plan B directly off drugstore
and supermarket shelves
without a prescription.
In a rare public split among
federal health officials, the
Health and Human Services
Department overruled a
decision by the Food and Drug
Administration to make the
drug available to anyone of any
age without a restriction.
In a statement, FDA
Administrator Margaret A.
Hamburg said she had decided
the medication could be used
safely by girls and women of all
ages. But she added that Health
and Human Services Secretary
Kathleen Sebelius had rejected
the move.
“I agree ... there is adequate
and reasonable, well-supported,
and 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,” Hamburg
said.
“However, this morning I
received a memorandum from
the Secretary of Health and
Human Services invoking her
authority under the Federal
Food, Drug, and Cosmetic Act to
execute its provisions and
stating that she does not agree
with the Agency’s decision to
allow the marketing of Plan B
One-Step nonprescription for all
females of child-bearing
potential,” she said.
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