FDA Orders Drug Safety PlansMar 31, 2008 | Parker Waichman LLP
The US Food and Drug Administration (FDA) just named 25 drugs and biologic products, including some well-known and popular medications, whose makers will be required to submit safety plans later this year. The product list as published in the Federal Register and includes the multiple myeloma medication thalidomide (Thalomid), the anti-psychotic medication clozapine (Clozaril), and the abortifacient drug mifepristone (Mifeprex). The plans, called Risk Evaluation and Mitigation Strategy—or REMS—plan must be submitted to the FDA no later than September 21 on pain of "enforcement action," which includes monetary penalties, the FDA said.
The move comes under amendments to the Food, Drug, and Cosmetic Act, which was passed last year and which also gave the FDA authority to require a REMS plan when a drug first goes to market or when the FDA is made aware of new safety data. The goal of REMS is to ensure the safe use of medications that have risks if used improperly, according to Jane Axelrad of the FDA's Center for Drug Evaluation and Research. "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," Axelrad said. "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," she added.
Drugs are deemed to need an REMS if:
• Clinician prescribers need specific training or experience or are specially certified.
• Pharmacies, practitioners, or healthcare settings dispenses the drug are specially certified.
• The drug is dispensed to patients only in certain healthcare settings, such as hospitals.
• The drug is dispensed to patients with evidence or other documentation of safe use conditions, such as laboratory test results.
• Patients using the drug are subject to certain monitoring or are enrolled in a registry.
The drugs on the list were all approved before March 25; however, medications approved after this date will have the REMS requirement imposed at the time of approval, the FDA said. Drugs that will need an REMS are:
Abarelix (Plenaxis), which is approved but not currently sold in the U.S.
Several formulations of Clozapine (Clozaril and Fazaclo ODT)
Fentanyl PCA (Ionsys), which is approved but not currently not sold in the U.S.
Fentanyl citrate (Actiq)
Several formulations of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)
The live smallpox (vaccinia) vaccine (ACAM2000)
Sodium oxybate (Xyrem)
Recently, lawmakers were concerned by the rash of drug recalls and have been urging regulators to implement standards to alleviate these issues. This influencing of actual drug usage is a change from the FDA's traditional role as that of monitor, or gatekeeper, for new drugs and medical products. Until now, the FDA developed the labels that detail how drugs are meant to be used, but it left the final prescribing decisions to doctors, who are not bound by federal guidelines and can prescribe medications for off-label—uses other than what is FDA approved—uses.