ACCELERATED APPROVAL REG REQUIRES PROMOTIONAL PRE-CLEARANCE

Executive Summary

Sponsors of accelerated approval drugs must continue to submit promotional materials to FDA for review after their products reach the market, the agency indicated in its proposed regulation for accelerated approval published in the April 15 Federal Register. The agency noted that "because drugs approved under the restricted use provision [of the reg] may be highly toxic or otherwise potentially harmful, FDA is concerned that certain promotional claims could cause inappropriate and, therefore, unsafe use." FDA also expressed concern that inappropriate promotion could "readily" affect the risk/benefit ratio for drugs approved on the basis of surrogate endpoints. The extent of review will vary on a case-by-case basis. FDA does not intend specifically to approve promotional materials, the reg states, but only to require their submission. "Accordingly, the sponsor must submit promotional materials to FDA during the approval process and subsequent to approval," the reg states. Materials developed after approval must be submitted 30 days prior to dissemination. "Inappropriate" labeling or advertising could be cause for withdrawal of the NDA, the reg notes (see related story, p. 8).