The U.S. Food and Drug Administration (FDA) has announced that it will seek Risk Evaluation and Mitigation Strategies (REMS) from 25 drugs and biologic products by September 21, 2008.

What is REMS?

REMS, or a Risk Evaluation and Mitigation Strategy, allows the FDA to require manufacturers to submit a strategy when a drug or product first comes on the market or at a later time if safety issues arise. REMS is allowed under the FDA’s 2007 Amendments Act.

Why is it important?

Certain drugs present a dilemma, according to an FDA press release:

They can provide an important benefit to patients, but they 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 the 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.

Drugs involved

The following drugs are included in the FDA’s REMS request:

Generic names: Abarelix Alosetron Ambrisentan Clozapine Dofetilide Eculizumab Fentanyl PCA Fentanyl citrate Isotretinoin Lenalidomide Mifepristone Natalizumab Small pox Sodium oxybate Thalidomide

Brand names: Plenaxis (3 brands) Lotronex Letairis Clozaril, Fazaclo, ODT Tikosyn Soliris Ionsys (3 brands) Actiq Accutane, Amnesteem, Claravis, Sotret Revlimid Mifeprex Tysabri ACAM2000 Xyrem Thalomid

Additional information

To view the FDA’s press release, go to: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01811.html/

If you or a loved one has been injured due to the use of any drug, contact an attorney to discuss your situation. We may be able to help. Consultations with a qualified attorney whose practice focuses in this area of the law are strictly confidential, free of charge and without obligation. To contact an attorney, please click here.