FDA releases list of 25 products to submit safety plans

WASHINGTON The Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy, the FDA said in a Federal Register notice published today.

Under the Amendments Act of 2007, FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” said Jane Axelrad, associate director for policy, Center for Drug Evaluation and Research, FDA. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”

Some of the drugs on the list include: Biogen Idec’s multiple sclerosis drug Tysarbi, Celgene’s multiple myeloma medicine Thalomid, Roche’s severe acne treatment Accutane, and Cephalon’s pain medication Actiq.

The Federal Register notice, which includes a list of all 25 drugs and biologic products that will be required to submit REMS, is available at www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf.