Drug safety: Isotretinoin makers to comply with new FDA monitoring plan

Key Points

National report - Manufacturers of isotretinoin are awaiting more information to determine whether iPLEDGE - the mandatory federal drug registry already in place - will meet the Food and Drug Administration's new safety plan requirements.

Isotretinoin is included on the FDA's first list of drugs and biologic products that must submit safety plans under new authority the agency was granted last year.

Under the 2007 FDA Amendments Act - which authorized changes to the Food, Drug and Cosmetic Act - the FDA can require so-called Risk Evaluation and Mitigation Strategy (REMS) plans when a drug is first introduced to the market or if the FDA becomes aware of new safety data.

Other drugs on the list include the schizophrenia drug clozapine (Clozaril, Novartis), multiple sclerosis drug natalizumab (Tysabri, Biogen Idec) and the pregnancy termination pill mifepristone (Mifeprex, Danco Laboratories).

Drugs are considered to have elements of safe use if:

Plan deadline

Under the requirement, the makers of the drugs, including the isotretinoin drugs Accutane (Roche Pharmaceuticals), Amnesteem (Genpharm), Claravis (Barr Laboratories) and Sotret (Ranbaxy), must submit their REMS plans no later than Sept. 21 or face penalties that could include fines.

But with the clock ticking, companies, including Roche, were still waiting at press time for specific instructions on how to ensure that iPLEDGE complies with the REMS requirement.

"Roche is looking forward to learning more details from the Interim Guidance for Industry, which has yet to be released, to ensure that the iPLEDGE program will comply with the proposed REMS submission," a company spokeswoman told Dermatology Times.

The FDA said it was working to put together guidance for companies regarding the content and format of a proposed REMS.

One issue to be worked out is that there is substantial overlap between REMS and existing regulations that require restricted distribution, and the FDA said it was determining whether any regulation changes would be needed to clarify the requirements.

"While the details of the REMS are still being worked out, we do not believe that the approved REMS will be substantially different from the existing risk management plans unless new safety information suggests that the existing plan is not working," a spokeswoman tells Dermatology Times. "We continue to monitor the safety of all of these drugs and will take appropriate actions when warranted," she says.

The FDA amendments came about after lawmakers, responding to a series of drug recalls, pushed to give the agency greater authority to monitor and manage risks over a drug's life cycle.

"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," says Jane Axelrad, associate director for policy at the FDA's Center for Drug Evaluation and Research, in a press release.

"The FDA approved the drugs identified ... before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS," she says.