Risk-Evaluation Plans Now Required

Rockville, MD (Apr. 3)-Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics. As part of the Food and Drug Administration Amendments Act passed last fall, manufacturers may be asked to submit a risk evaluation and mitigation strategy (REMS) to FDA when a drug is first marketed, or later if FDA becomes aware of new safety data about the drug. In a Federal Registernotice published last week, FDA identified several drugs and biologic products for which companies will be required to submit such safety plans by Sept. 21, 2008.

The purpose behind REMS is to ensure that drugs are prescribed and used properly. For example, said FDA in a Mar. 27 release, certain drugs “may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage.” The agency has approved drugs and biologics with REMS before, but the implementation of the Amendments Act gives FDA explicit authority to require the safety plans and to take action against companies who do not comply. The new authority will be applied to drugs approved after Mar. 25, 2008, as well as for already marketed drugs for which new risks are identified after Mar 25, 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 at FDA’s Center for Drug Evaluation and Research, in the release.

FDA asked for comments about whether other drugs or biologics should be added to the list for REMS requirements. The current list is located here.