Plan B decision made before data review: FDA staff

Fri Aug 4, 2006 1:00 AM ET

By Susan Heavey

WASHINGTON (Reuters) - The decision whether the U.S. Food and Drug Administration should approve wider access to a morning-after contraceptive drug was made well before agency scientists finished their final review, two FDA officials said in court documents released on Thursday.

Supporters of over-the-counter sales for Barr Pharmaceuticals Inc.'s Plan B pills have accused top FDA officials of hindering the company's bid for nonprescription sales for years, to please conservative supporters of President George W. Bush's administration.

The documents come just days after the FDA said it would reopen discussions over the drug, which can prevent pregnancy if taken within 72 hours of sexual intercourse. The delay had stirred debate over politics and science and held up the confirmation of two agency chiefs.

In a sworn statement in June, Dr. John Jenkins, director of the FDA's Office of New Drugs, said he learned in early 2004 that then-FDA Commissioner Mark McClellan had decided against approval before the staff could complete their analysis.