Pfizer, Inc. – FDA Warning Letter, Aug 10, 2009

This FDA Warning Letter to Pfizer, Inc. details significant violations observed during a June 29 - August 10, 2009, inspection regarding Postmarketing Adverse Drug Experience (PADE) reporting and Prescription Drug Marketing Act (PDMA) compliance.

**PADE Violations (21 CFR 314.80, 314.81):** * **Failure to submit ADE reports:** Numerous serious and unexpected ADEs, including for Dalacin, Camptosar, Lyrica, Lipitor, and Viagra (specifically NAION-related visual events), were not submitted within 15 days. Some Viagra reports were misclassified as non-serious. * **Inadequate written procedures:** Procedures for identifying, assessing, and reporting adverse events were insufficient, particularly for fosphenytoin (Purple Glove Syndrome), with inadequate training provided to global pharmacovigilance staff. * **Late submission of 15-day Alert Reports:** A significant percentage of serious and unexpected ADE reports (4% in one period, 9% in another) were submitted late, some by hundreds of days. This issue persisted despite a new tracking system and prior FDA 483s. * **Late submission for waiver products:** Reports for Provera (30-day waiver) and Bextra (60-day waiver) were also submitted late. * **Failure to submit reports from postmarketing