November 14, 2005

FDA’s contraceptive review called ‘unusual’

WASHINGTON (Reuters) - The U.S. Food and Drug
Administration's initial review of Barr Pharmaceuticals Inc.'s
bid to sell the Plan B "morning-after" contraceptive without a
prescription was "unusual," congressional investigators said in
a report released on Monday.

"FDA's high-level management was more involved in the
review of Plan B than in those of other (over-the-counter)
switch applications," the Government Accountability Office said
in a report.

The GAO report probed the FDA's May 2004 decision to reject
Barr's initial application to sell Plan B over the counter.
Barr later amended its bid, and the FDA indefinitely postponed
a ruling on that request in August.

The GAO said there were "conflicting reports" about whether
the decision to turn down the initial application was made
before agency staff completed their reviews.

The investigation was done at the request of congressional
Democrats, who say the FDA has been swayed by objections from
political conservatives rather than science.

The GAO said the FDA disagreed that the involvement of
senior officials was atypical.