FDA Identifies Requirements for Safety Plans for Certain Drugs and Biologics

The U.S. Food and Drug Administration (FDA) has identified 25 drugs and biologic products that will be expected to turn in safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a recently published Federal Register.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA can expect manufacturers to turn in a REMS when a drug first goes to market, or later if the FDA becomes aware of new safety data regarding the drug. The manufactures of the 25 drugs and biologic products identified in the notice must submit proposed REMS to the FDA, no later than September 21, 2008.

Specific drugs can present health conflicts – while they can provide important benefits to the patient, they can be especially dangerous if not used properly. For instance, some drugs may be safe for patients, but taken when pregnant can harm the fetus. Rather than deny FDA approval of such drugs, the agency has granted approval but requires the manufacturer to develop a safety plan or REMS to ensure the drugs are prescribed correctly and patients are using them correctly.

“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.”

The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS in more detail, is here.