NDA rejections don't signal tougher reviews

Medical Marketing and Media, Sep 2001 by Dickinson, James G

Could a recent spate of drug "not approvable" decisions by the Food and Drug Administration (FDA) and its expert advisory committees signal a more cautious agency? Not at all, FDA director of drugs Janet Woodcock told Dow Jones Newswire on August 2. While the agency does not track favorable or non-favorable advisory committee decisions to look for trends, Woodcock said there are those who look at high-profile advisory committee or agency rejections and "think they discern a trend." But Woodcock said she doesn't see it.

"We try to aim for consistency of review, and we don't believe there is a shift in the standard," Woodcock told Dow Jones. "We believe we have to have the same high standard. We haven't changed our definitions for 12 or 13 years."