Accutane/Generics Risk Program Should Include Mandatory Follow-Up Survey
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA advisory committee suggests enhancements to Roche's SMART program to better prevent pregnancies. The proposal calls for a shared brand/generic system for patient registration.
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A single centralized pregnancy risk management program for Roche's Accutane and generic isotretinoin products should include a mandatory post-treatment survey, a joint FDA advisory committee said Feb. 27. "I think it is critical to have a follow-up survey both to get better quality assurance about what is working in the program and what is not because I think there will be need for clarifications down the road. And we need to have the best data possible to make those decisions on, and also as a tool to better ascertain pregnancies," voting consultant Margaret Honein, PhD, Centers for Disease Control & Prevention, said. Members from FDA's Drug Safety & Risk Management and Dermatologic & Ophthalmic Drugs Advisory Committees concurred by a vote of 16 to 8 that a proposed enhancement of Roche's SMART (System to Manage Accutane-Related Teratogenicity) program could serve as the core of a new single centralized system that would be used by all isotretinoin manufacturers to prevent pregnancies and birth defects. A voluntary post-treatment survey was a feature of the SMART program; however, it only achieved a response rate of 28.2% during its first year, well below the 60% benchmark set by Roche. Follow-up should extend for least 30 days post-treatment, committee members suggested. "I am also concerned, as we have said before, about patients after their treatment course beyond the 30 days, that there should be some, at least one, attempt to systematically follow up with those patients" voting consultant Jurgen Venitz, MD/PhD (Richmond, Va.), said. Extended follow-up surveys have not been successful in the past because there is no incentive for patients to complete them, Roche said. FDA convened the joint advisory committee meeting to review the current risk management programs for isotretinoin, which the agency concludes have shown "minimal to no improvement" in preventing pregnancies. [To 1 watch a webcast of this meeting, go to FDAAdvisoryCommittee.com.] During the first year of SMART, 120 cases of pregnancy were reported among patients on isotretinoin, down seven cases from the previous year. There was, however, a decline in prescriptions of 23% during the period (2 (Also see "Accutane Pregnancy Exposure May Have Increased Under Risk Management Plan, FDA Says" - Pink Sheet, 19 Feb, 2004.)). SMART, which began in April 2002, requires patients to pass two pregnancy tests before receiving a prescription. Physicians confirm the test results by applying a sticker to the prescription; pharmacists were not to fill prescriptions that did not have a sticker. Generic isotretinoin manufacturers used identical programs. FDA specifically expressed concern about the SMART sticker program. The agency noted that use of the qualification stickers did not always correspond with two negative pregnancy tests. In response to a Dec. 10 meeting with the agency, isotretinoin sponsors - Roche (Accutane), Mylan/Bertek/Genpharm ( Amnesteem ), Ranbaxy ( Sotret ) and Barr ( Claravis ) - proposed a modified risk management program that would create an interactive registry for all patients on the retinoid. Under the revised program, patients would be entered into the registry when isotretinoin therapy is decided upon and the receipt of a negative pregnancy test. After the first doctor visit, the patient would access the registry and answer questions on appropriate birth control use and dosing during isotretinoin therapy. The patient must then obtain a second negative pregnancy test to receive the prescription. The results from both pregnancy tests would be entered into the registry by the physician, and the pharmacist would contact the registry and receive an authorization before dispensing isotretinoin. Committee members further suggested that in addition to isotretinoin prescribers, pharmacists should be registered. Under the manufacturers' proposal, pharmacies, but not individual pharmacists, would be registered. "It makes no more sense to certify pharmacies than it does to certify physician practices as opposed to physicians. The point is, the individual clinician is the one who is going to be doing the care," drug safety committee member Brian Strom, MD, University of Pennsylvania, said. - Adam Eckstein |