Plan B Decision Delayed Again

Barr says the FDA plans to seek public comment on the drug's potential OTC status.
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A decision on

Barr Pharmaceuticals'

(BRL)

nonprescription Plan B emergency contraceptive has been delayed once again.

The Food and Drug Administration said it's not ready to approve an over-the-counter version of the drug, despite saying the data Barr provided with its supplemental new drug application were acceptable.

Before making a decision, the FDA plans to seek public comment on the drug's potential OTC status. The FDA didn't commit to any timetable for initiating or concluding the proceeding, according to a Barr press release.

Shares of Barr fell $1.06, or 2.4%, to $45.22 in after-hours trading.

In December 2003, two FDA advisory committees voted to support the sale of Plan B as a nonprescription product for all women. In May 2004, the FDA, in a rare move, overruled the committees and rejected Plan B.

The agency said at the time that Barr didn't provide "adequate data to support a conclusion that Plan B can be used safely by young adolescent women" for emergency contraception without a doctor's prescription.