FDA EIR - Horizon Pharma USA, Inc. - September 30, 2014

The FDA conducted a postmarketing adverse drug experience (ADE) reporting inspection of Horizon Pharma USA, Inc. in Deerfield, IL, from September 23 to September 30, 2014. This was a performance goal inspection focusing on Postmarketing Adverse Drug Experience Reporting and Drug Quality Reporting System requirements. While no formal inspectional observations (FDA-483) were issued, two significant procedural issues were discussed with company management.

First, the firm's main ADE reporting procedure did not reference its global counterpart, which employees primarily followed. It also lacked clarity regarding the required steps and 15-calendar-day timeline for postmarketing 15-day follow-up Alert Reports. Second, the company's NDA Field Alert reporting procedure inaccurately defined the start of the 3-day reporting clock for Field Alert Reports (FARs), indicating it began upon confirmation of an issue rather than when the problem first became known. This procedure also ambiguously associated all field alerts with product recalls.

Horizon Pharma USA, Inc. committed to revising its ADE reporting procedures to include proper referencing and clarify follow-up reporting timelines. They also agreed to amend the NDA Field Alert reporting procedure to accurately reflect the 3-day submission timeframe and differentiate FARs from product recalls. Management assured that all necessary corrections would be implemented within 30 days.