FDA issues REMS list

FDA on Wednesday published a list of approved products for which manufacturers will be required to submit a proposed risk evaluation and mitigation strategy (REMS). The FDA Amendments Act (FDAAA) requires that sponsors of drugs that are already subject to risk management procedures must submit a REMS by Sept. 21. REMS can include restrictions on distribution and on conditions of use, including settings where drugs can be administered and/or who can prescribe them, as well as requirements that patients be monitored or enrolled in a registry.

Provisions of FDAAA allowing FDA to require a REMS for new products came into effect on March 25. FDA said on Wednesday that it will determine during the approval process if a REMS is required "to ensure that the benefits of the drug or biological product outweigh the risks. If so, FDA will require the sponsor of the application to submit a proposed REMS and the REMS will be approved when the drug or biological product is approved/licensed." The agency also can require a REMS after a product is approved. FDA said it will issue guidance on the preferred content and format of a proposed REMS, including a template and model REMS, "as soon as possible." ...