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Oral poster presentation: Evaluation of US Package Inserts Following the Physician Labeling Rule
James Buchanan, PharmD, Sr. Vice President Pharmacovigilance and Risk Management and Sally Van Doren, PharmD, President & CEO, BioSoteria, Inc.

Background: FDA issued a guidance document entitled Adverse Reactions (AR) Section Labeling for Human Prescription Drug and Biological Products and Format in January 2006. This guidance is intended to assist both applicants and reviewers in drafting the AR section of the prescribing information in the new format specified by the new labeling rule.

Objectives: To determine if new or updated US package inserts released after January 2006 FDA guidance, follow the new labeling rule with regard to threshold and criteria for AR inclusion in product labeling.

Methods: Drug products with new or updated US package inserts after January 2006 through December 2007, were identified by a search of the FDA website; only those in the new labeling format were further evaluated. The clinical safety AR sections was reviewed to determine if the FDA guidance criteria and thresholds for AR inclusion were followed.

Results: Thirteen US package inserts were identified in the updated labeling format. Clinical trial AR tables were selective in those ARs included. The use of a threshold event rates was common with all labels; however, different thresholds were used across labels. Labeling was found to be inconsistent in approach for inclusion of ARs with higher incidence compared to placebo. There was even greater variability in AR inclusion when treatment groups compared to active comparator.

Conclusions: The review of recently updated US Package inserts following the FDA new labeling rule indicates that many, but not all, of the guidance concepts are being applied with regard to AR inclusion and display. It is anticipated as both FDA reviewers and marketing applicants become more familiar with this new process, that the resulting labels will more closely match the intent and direction of the guidance document.