FDA Expands Risk Evaluation and Mitigation Authority

The U.S. 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 (REMS), FDA said in a notice published in the Federal Register on March 27.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), 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 the notice must submit to the agency a proposed REMS by Sept. 21, 2008.

FDA says that certain drugs present a dilemma as they can provide an important benefit to patients, but can be especially dangerous if not used properly. For example, certain drugs may be safe and effective for patients, but if taken while pregnant can harm the fetus or cause miscarriage. Rather than deny FDA approval of such drugs, the agency has granted approval and required that the manufacturer develop a safety plan, or REMS, to help ensure that health care professionals prescribe the drug correctly and that patients use it safely. While FDA has previously approved some drugs and biologics with these safety plans, the new law makes explicit FDA's authority to require them and contains specific enforcement authority when violations or noncompliance with the plan's requirements occur.

"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."

In addition, FDA also is implementing the new authority for drugs that will be approved after March 25, 2008, as well as for already marketed drugs for which new risks are identified after March 25.

FDA is advising the public to notify the agency if they believe other drugs should be considered to have REMS under the new statutory provisions. The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.htm.

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