FDA Rejects Narcotic Painkiller Program (REMS), Says Too Weak to Stop Abuse

A Food and Drug Administration (FDA) panel voted July 23 to reject a program that would monitor painkillers and narcotics. The agency responded to the proposed plan, indicating that the risk evaluation and mitigation strategy (REMS) was not strong enough to limit the abuse associated with these medications.

Although the FDA has not approved the REMS proposal to counteract the risks linked to drugs like OxyContin and fentanyl, it has effectively created risk management plans in the past that have restricted patients’ access to other potentially dangerous medications.

A well-known example involves the iPLEDGE Accutane program. iPLEDGE was implemented after patients reported serious side effects linked to the popular acne drug and prompting many to file Accutane lawsuits. Due to the serious birth defects associated with Accutane, the program requires all patients to register online and women who may become pregnant to verify two forms of birth control.

The FDA approved iPLEDGE in 2005. Since Accutane was first released to the public in 1982, the drug has undergone stringent label and boxed warning updates and several revised risk management plans.

iPLEDGE builds off of previous programs, using the established warning information, and combines a strict performance-linked access s system  (PLAS) with a pregnancy registry. PLAS requires wholesalers, pharmacies, prescribers and patients to register with the program or forfeit access to the acne medication.

Although Accutane was taken off the market in 2009, the iPLEDGE program is still in place to monitor patients taking isotretinoin, the generic form of Accutane, and other acne drugs that use isotretinoin like Amnesteem, Claravis and Sotret.

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