Isotretinoin manufacturers expect to implement an enhanced risk management plan in mid-2005 that includes patient and pharmacy registries.

"All prescribers, patients and dispensing pharmacies will be registered in a single, centralized 'clearinghouse,'" a Nov. 23 FDA "¹ Talk Paper" outlining the new isotretinoin risk management program states.

Implementation of the enhanced program was held up by Celgene patents covering the STEPS (System for Thalidomide Education and Prescribing Safety) risk management program for Thalomid , which employs a central registry for physicians, patients and pharmacies(² Also see "Accutane Risk Management Program Changes Held Up By Celgene Patents" - Pink Sheet, 13 July, 2004.).

The four isotretinoin manufacturers - Roche ( Accutane ), Barr ( Claravis ), Mylan/Bertek/Genpharm ( Amnesteem ) and Ranbaxy ( Sotret ) - reached agreements with Celgene to license patents covering the STEPS program.

The manufacturers will pay Celgene an up-front fee and royalties. The financial arrangements will be consistent among the manufacturers, Celgene said.

Covance will design, build, implement and operate the risk management program.

Enhancements to Roche's SMART (System to Manage Accutane Related Teratogenicity) and identical programs employed by the generic manufacturers were recommended by a joint advisory committee Feb. 27 (³ Also see "Accutane/Generics Risk Program Should Include Mandatory Follow-Up Survey" - Pink Sheet, 27 February, 2004.).

SMART, which began in April 2002, did not result in a significant decrease in the number of fetal exposures in its first year of implementation.

In addition to the registries, the new plan will require patients to submit negative pregnancy test results from "certified laboratories" to prescribers and pharmacies before receiving the prescription each month.

As under the current SMART program, the patient must complete "informed consent, education and risk management components," FDA's Talk Paper says.

The four manufacturers formed a steering committee to develop the risk management program in consultation with FDA.

The risk management plan is likely to face greater scrutiny following FDA Associate Director for Science David Graham's, MD, congressional testimony that several marketed drugs, including Accutane, have serious unresolved safety concerns (⁴ Also see "Crestor, Serevent Are Among Problem Drugs Cited By FDA Safety Reviewer" - Pink Sheet, 18 November, 2004.).

- Andrew Kasper

Enhanced Isotretinoin Risk Management Plan To Commence In Mid-2005

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