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Regulatory News | 09 May 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest.
Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effectiveness of devices for use in the circulatory system and makes recommendations to FDA with regard to approval.
On 24 May, the committee will evaluate the premarket approval application (PMA) for St. Jude Medical’s Amplatzer Patent Foramen Ovale (PFO) Occluder device, which is a permanently implanted cardiac device intended to close patent foramen ovale for the prevention of recurrent stroke in some patients.
But Page’s employer, the University of Wisconsin School of Medicine and Public Health, ran a clinical site that participated in the trial supporting the device’s PMA, and according to FDA, was awarded between $10,001 and $25,000 in 2015 and between $5001 and $10,000 so far in 2016 in funding from St. Jude Medical for trial-related activities.
Although Page was not personally involved in the trial, the study’s investigator is on the faculty of the Division of Cardiovascular Medicine and reports to the Chief of the Division, which is one of 23 divisions within the Department of Medicine, of which Page is the chair.
“Due to the large number of study sites, it was very difficult to identify panelists with relevant expertise who had no affiliation with a clinical study site for the PFO Occluder Advisory Panel,” FDA said in granting the waiver for Page. “In our panel preparation process, we approached multiple individuals who have experience in these areas, but were unsuccessful in finding the range of experience equivalent to that of Dr. Page.”
FDA has had issues with adding new members to device advisory committees for years.
And Page’s understanding of the benefit-risk issues associated with PFO closure and his previous experience chairing “a very challenging and controversial advisory panel meeting,” which shared many of the same considerations as the PFO Occluder panel on 24 May, was factored into granting the waiver, the agency said.
“We expect that the Panel deliberations will be complex and potentially contentious, such that an experienced Chair like Dr. Page is essential,” FDA said. “It is also critical to have an advisory panel that has a good balance between surgical and non-surgical perspective because while PFO closure has traditionally been in the surgical field of practice, this device is intended for use by a cardiologist. The AMPLATZER PFO trial included 925 subjects at 62 US sites.”
And although Page is employed by a participating study site, he does not have any involvement or oversight with the trial, FDA noted. In addition, the Wisconsin study site enrolled a total of 23 (2.5%) subjects, a small percentage of the trial's overall US sample size. No additional subjects have been enrolled since August 2011, and no additional subjects are being recruited to participate in the study at the site, FDA said.
“Dr. Page’s knowledge of cardiovascular diseases and clinical trial design will provide the necessary expertise for this important discussion,” the agency concluded.
And although some may believe the conflict of interest will influence Page's vote and chairmanship of the panel, studies proving conflicts of interest have an impact on how advisory committees vote have been going back and forth for years, and most of the issues seem to stem from undisclosed conflicts of interest.
2016 Meeting Materials of the Circulatory System Devices Panel
Tags: medical device panel, St. Jude Medical, Amplatzer, PFO Occluder, FDA advisory committee, conflict of interest