REMS Strength Driven More By Drug’s Benefits Than Risks, FDA Suggests

05 Nov 2012

• By Martin Berman-Gorvine

FDA is unwilling to subject organ transplant patients to the delays caused by requiring prescriber and pharmacy certification, and so the REMS requirements for mycophenolate products are less strict than for other, less critical teratogenic drugs.

A new Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate drugs such as Novartis Pharmaceuticals Corp.’s Myfortic (mycophenoic acid) and mycophenolate mofetil (Genentech Inc.’s CellCept and generics) due to the risk of birth defects is milder than the REMS for two other teratogens due to the critical nature of the indication – prevention of organ transplant rejection.

FDA does not want a delay in administering the drugs, such as might be caused if the mycophenolate REMS included...