FDA WARNING_LETTER - GlaxoSmithKline - November 13, 2007

An FDA inspection conducted from August 20 to November 13, 2007, at GlaxoSmithKline's corporate headquarters in Research Triangle Park, NC, focused on Postmarketing Adverse Drug Experience (PADE) and other postmarketing reporting requirements for Avandia (rosiglitazone maleate), NDA 21-071. The inspection revealed the firm failed to report clinical experience data and other information as required by Section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Sections 314.80 and 314.81. Specific violations included incomplete Periodic Reports lacking a history of actions taken due to adverse drug experiences (21 CFR 314.80(c)(2)(ii)(c)), and incomplete Annual Reports from 2001-2007 that failed to include status reports for numerous postmarketing studies (21 CFR 314.81(b)(2)(viii)) and the status of the ADOPT study in the 2007 report (21 CFR 314.81(b)(2)(vii)). The FDA noted GSK lacked appropriate knowledge of Avandia studies, leading to these deficiencies. GSK's response to the Form FDA 483 was deemed inadequate, failing to explain how the firm would ensure submission of all mandatory postmarketing reporting information for its approved drug products. The FDA expects comprehensive corrective actions, including an evaluation of reporting for all approved drug products. Failure to correct these serious violations may result in regulatory actions, impact federal contracts, and delay approval of pending applications. A written response detailing corrective actions and prevention of recurrence is required within fifteen working days.