Public Health Coalition Says US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff
BISA is part of the Patient, Consumer and Public Health Coalition. The Coalition recently sent a letter to the FDA’s Commissioner Robert Califf expressing concerns about Advisory Committees.
The Patient, Consumer, and Public Health Coalition is an informal coalition of nonprofit organizations representing the interests of patients, consumers, health-care professionals, scientists, public health experts, and advocates.
Sue Stutter of Pink Sheet wrote an article summarizing the letter, highlighting the Coalition’s concerns. “In a letter to Commissioner Robert Califf, the Patient, Consumer and Public Health Coalition says medical product center directors and other senior staff should refrain from trying to sway advisory committee votes and be reminded that overruling decisions of their own scientific staff undermines the public trust.”
“FDA advisory committee members often agree with scientific and statistical concerns and conclusions expressed in the FDA scientific memoranda provided to them to review, and it is the center directors or other officials that are overriding the views of FDA scientific reviewers.”
According to Sutter, “the letter offers four recommendations for Califf to consider as he weighs changes in the advisory committee meeting process:
Provide training to advisory committee members to help them understand the statistical analyses that are an essential part of all meetings and ensure they respect the importance of understanding and considering scientific evidence as part of their advisory role.
Require that the FDA scientific and statistical staff who write advisory committee briefing documents have the freedom to express their own views and that those views are accurately presented in oral presentations at the meeting.
Encourage center directors and other FDA officials to refrain from making comments at advisory committee meetings that can be interpreted as encouraging panelists to vote in a particular way.
Remind product center directors and other FDA officials that overruling the views of their own scientific and statistical staff undermines the public trust and should be avoided, especially when the scientific staff are in consensus.”
Read the full article.
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“The FDA continues to explore ways to optimize its advisory committees to ensure the agency gets timely and sound advice from these committees and will communicate any updates when available.”
BISA’s Recent Involvement with Patient, Consumer and Public Health Coalition
May 2023 -
BISA Represents at Patient Consumer and Public Health Coalition Meeting with the Center for Medicare and Medicaid Services (CMS)
March 2023 -
Coalition Meeting with Commissioner Califf and Key FDA Officials
Resources
FDA: Food & Drug Administration
Pink Sheet - Pharma Regulatory and Policy Insights
Pink Sheet: US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says
Patient, Consumer and Public Health Coalition
Breast Implant Safety Alliance (BISA) is a 501(c)3 women-owned nonprofit, patient-centered organization dedicated to improving breast implant safety and awareness—through direct collaboration with consumers, medical professionals, manufacturers, regulators, and advocates. BISA is a 100% volunteer organization not funded by implant manufacturers.
Contact: Maria Gmitro, President | 843.501.6873 | maria@bisanonprofit.org