Regulatory Focus™ > News Articles > Group Nominates More Than 60 Scientists to Fill Advisory Committee Vacancies

Group Nominates More Than 60 Scientists to Fill Advisory Committee Vacancies

Posted 19 June 2012 | By

Just how hard is it to find un-conflicted experts for the US Food and Drug Administration's (FDA) Advisory Committees? The question is at the heart of a long-running skirmish between FDA, industry, and public interest groups-all of whom have different interpretations regarding how easy it is to find unconflicted experts to staff the agency's advisory committees, and if it even matters to begin with.

Now, the public interest group Union of Concerned Scientists (UCS), has moved to nominate dozens of scientists to advisory committee vacancies in light of what it refers to as overblown concerns from industry.

"Pharmaceutical and medical device companies, and some in Congress, argue that it's difficult to find independent experts to serve on FDA's scientific advisory committees due to strong financial conflict of interest standards," Mark Halpern, program manager for Scientific Integrity at UCS wrote in a statement. "Our experience proves otherwise."

Halpern said UCS was able to find enough un-conflicted experts to fill fully half of FDA's advisory committee vacancies, which currently stands at more than 100, in just a single email to its distribution list. It said it has nominated the 61 scientists who responded to its letter for inclusion on the advisory committees to "ensure that [FDA's] panels are free from inappropriate financial influence.

Accounts of conflict of interest are not unknown to FDA, who in January faced an uproar over reports that several panelists on an advisory committee assessing the safety of drospirenone products had ties to the companies whose products they were evaluating for safety and effectiveness. FDA responded by saying the conflicts were minor and did not require a waiver.

Shortly thereafter the agency moved to release new guidance on disclosing conflicts of interests to the public through a standardized mechanism. While UCS said it expects the final version of the Food and Drug Administration Safety and Innovation Act (FDASIA) to contain looser conflict of interest requirements than are currently allowed, it says it is incumbent upon FDA to "aspire to select as few conflict experts as possible."

"Financial ties should never play a role when evaluating the safety of pharmaceutical drugs [or] medical devices," said Halpern.


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