The most frequent complaint to the Center for Drug Evaluation & Research Ombudsman's office in 2006 concerned implementation of the iPLEDGE program, the office said in its annual report, issued Feb. 28.

The risk management program launched last March as a way to ensure that acne therapy isotrentinoin (Roche's Accutane and generics) is not prescribed to pregnant patients. The program includes registration requirements for wholesalers, prescribers, and pharmacies (¹ Also see "FDA Requires Multiple Reports On New Accutane Risk Management Program" - Pink Sheet, 22 August, 2005., p. 14).

The number of complaints is not wholly unexpected. According to a survey conducted by the American Academy of Dermatology Association last fall, 95 percent of dermatologists interviewed use isotretinoin in their practices, and of those, 90 percent reported difficulties with iPLEDGE (² Also see "Accutane iPLEDGE Program Glitches Continue Six Months After Launch – AADA" - Pink Sheet, 4 September, 2006., p. 15).

The Ombudsman's office did not review any disputes under its pilot program "Documenting Differing Professional Opinions and Dispute Resolution" in 2005 or 2006, "although there have been several public complaints by reviewers on topics such as the approval of the [Sanofi-Aventis] antibacterial drug Ketek (telithromycin) tablets, and general drug safety review procedures."

In addition, the ombudsman "responded to hundreds of informal jurisdiction questions that helped guide product development" in 2006. The report notes in cases when the regulatory assignment is not clear, a sponsor may submit a Request for Designation to FDA. The agency received 76 such requests in 2006, most of which were drug-device combination products.

Overall, the Ombudsman's office "had less hot topics in 2006 with consumers than in 2004 and 2005, but complaints about the unwanted e-mails from on-line pharmacies and direct-to-consumer advertising were certainly prominent," the report states.

"Numerous consumers requested assistance in reporting drug adverse events, and others commented on the high cost of medication, seizure of medications ordered from Canada, abuse of oxycodone, and the politicizing of FDA," according to the report.

Accutane iPLEDGE Program Tops CDER Ombudsman’s 2006 Complaint List

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