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FDA Public Health Advisory
Strengthened Risk Management Program for Isotretinoin
Revised October 28, 2005: To allow more time for registration and activation, the implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered/activated in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. The starting date to begin patient registration and qualification in iPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin.
The Food and Drug Administration is announcing the approval of a strengthened risk management program, called iPLEDGE, for Accutane and generic isotretinoin. The sponsors have agreed to implement a program that requires registration in the iPLEDGE program of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities designed to minimize pregnancy exposures in order to distribute, prescribe, dispense and use Accutane. FDA approved this program under its regulations at 21 CFR 314, Subpart H.
Isotretinoin is approved to treat the most severe form of acne (nodular acne) that has not responded to other acne treatments and that can leave permanent scars. However, isotretinoin can cause birth defects. Previous programs to reduce the risk of fetal exposure to isotretinoin were assessed in February 2004 by the FDA and the results of the assessment were presented at a joint meeting of the Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees. Those committees strongly recommended the need for improvements in the isotretinoin risk management program to strengthen processes to ensure pregnancy testing and counseling of patients before and during treatment to reduce the risk of fetal exposure. The iPLEDGE program is a technology-based, closed system of registered wholesalers, prescribers, pharmacies, and patients.
The following are key elements of iPLEDGE:
- Starting December 30, 2005, only wholesalers registered with iPLEDGE will be able to obtain isotretinoin from manufacturers.
- Starting December 30, 2005 only pharmacies registered with iPLEDGE will be able to receive isotretinoin from registered iPLEDGE wholesalers.
- Starting March 1, 2006, iPLEDGE pharmacies must obtain authorization from the iPLEDGE system before filling any Accutane prescription. If the patient is registered, the pharmacist will receive an iPLEDGE authorization. For females of child bearing potential, this authorization is based on a current, valid negative pregnancy test result. Only prescriptions from prescribers registered in iPLEDGE will be accepted.
- iPLEDGE Prescribers must agree to assume the responsibility for pregnancy counseling of female patients of childbearing potential. Prescribers must obtain and enter into the iPLEDGE system negative pregnancy test results for those female patients of childbearing potential prior to prescribing isotretinoin.
- The sponsors will provide educational programs and materials for all parties in iPLEDGE regarding the risks of isotretinoin and program requirements.
- The sponsors will implement a reporting and collection system for serious adverse events associated with the use of isotretinoin through iPLEDGE. All pregnancy exposures to isotretinoin must be reported immediately to the FDA via the MedWatch 1-800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654 or on the website: www.ipledgeprogram.com.
- The sponsors and FDA will assess pregnancy rates and compliance with program requirements to monitor the success of the program.
Wholesalers, pharmacies, and prescribers can begin registering for iPLEDGE in September, 2005. Patients can begin registering for the program on December 30, 2005. For information on how to register, see www.ipledgeprogram.com.
In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin.
iPLEDGE is a jointly supported risk management program developed for Roche Pharmaceuticals and generic manufacturers Genpharm, Mylan/Barr, and Ranbaxy, by a contractor, Covance, Inc. It meets the recommendation of the
2004 Joint Advisory Committee for a single, mandatory, strengthened risk management plan for all marketed isotretinion products that links access to isotretinoin with pregnancy testing to lower the chances of drug exposure during pregnancy.
FDA is working closely with the manufacturers of isotretinoin to implement and then fully evaluate the iPLEDGE program. A public advisory committee meeting will be held in the future to discuss pregnancy exposure risk reduction under iPLEDGE. More information is available on the website:
http://www.fda.gov/cder/drug/infopage/accutane/default.htm.
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Date created: August 12, 2005, updated: October
28, 2005
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