BioCentury
ARTICLE | Company News

FDA panel votes to ease Lotronex REMS

July 11, 2013 12:02 AM UTC

FDA's Drug Safety and Risk Management Advisory Committee recommended modifying the REMS with elements of safe use (ETASU) for irritable bowel syndrome drug Lotronex alosetron from Prometheus Laboratories Inc. to ease the burden on pharmacists. The panel voted to eliminate the requirement that pharmacists verify the presence of a sticker to indicate that prescribers are following the conditions of safe use for the drug. Of 18 panel members, 13 voted to integrate e-pharmacy management systems to verify prescriber certification, and one member voted to replace the sticker requirement with non-mandatory prescriber training and education. The remaining four members backed other modifications to the REMS, including adding a patient registry (see BioCentury Extra, July 8). ...