FDA EIR - Portola Pharmaceuticals, Inc. - December 17, 2019

An FDA routine Postmarketing Adverse Drug Experience (PADE) inspection of Portola Pharmaceuticals, Inc. was conducted from December 11-17, 2019, in South San Francisco, California. The inspection assessed the company’s adherence to PADE reporting requirements, covering areas such as written procedures for adverse event surveillance, evaluation, and reporting, and vendor agreements, for its approved products, Bevyxxa (betrixaban) and Andexxa (andexanet alfa).

While no official Form FDA 483 (Inspection Observations) was issued, the inspection revealed several discussion items. Notably, four serious suspected adverse experiences for Andexxa were initially misclassified as expected but were later determined to be unexpected, lacking inclusion in the US Package Insert. Portola Pharmaceuticals is currently investigating the root cause of this misclassification. Additionally, the Bevyxxa 2018 Annual Report was found to be missing the required labeling and distribution data sections, although the subsequent 2019 report rectified this omission. The inspection also identified that several Periodic Adverse Drug Experience Reports (PADERs) for Andexxa were submitted late to the agency. The company's overall procedures for handling adverse event reports were found to be generally adequate.