Expertise Outweighs Conflict of Interest in FDA Adcom Meeting

The FDA granted a waiver to allow a device expert with a potential conflict of interest to participate in an advisory committee meeting.

Richard Page, chairman of FDA’s Circulatory System Devices Panel, acknowledged a financial conflict of interest because he is employed by the University of Wisconsin School of Medicine and Public Health, which was a clinical site for St. Jude Medical’s Amplatzer PFO Occluder study.

On May 24 the panel will discuss, make recommendations and vote on the PMA.

The FDA noted Page was not directly involved in conducting the RESPECT trials, or providing input on investigator activities. As chair of the Department of Medicine, he also was not personally involved in industry grants, contracts or other relationships.

The waiver cites his expertise in clinical trial design, benefit-risk analysis, in-depth understanding of treatment strategies and knowledge of cardiovascular diseases.

Read the waiver notice here: www.fdanews.com/05-10-16 WaiverCirculatorySystemDevicesPanel.pdf. — Joya Patel