April 28, 2016
Public Citizen Sues FDA for Release of Unredacted Curricula Vitae of Advisory Committee Members
Agency Blacks Out Information Concerning Professional Relationships and Grants From Private Companies on the CVs of Experts Serving on Its Advisory Committees
WASHINGTON, D.C. – Public Citizen has filed a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA), asking the agency to post unredacted copies of the curricula vitae (CV) of advisory committee members on its website.
The FDA has approximately 50 advisory committees composed of outside experts who advise the agency on issues such as whether the FDA should approve new medical products or change a product’s labeling. The FDA frequently follows the recommendations of advisory committees. Despite the fact that CVs are created for the specific purpose of being shared, the FDA redacts information from most of the advisory committee members’ CVs posted on its website.
The FDA blacks out information in the CVs about the dates of degrees conferred, the names of professional colleagues and mentors, the amounts of grants received from private companies, and the names of presentations and unpublished articles. Redactions of such information deny the public access to information that may bear on the qualifications, backgrounds and potential biases of advisory committee members, Public Citizen maintains.
Dr. Michael Carome, an advisory committee member and director of Public Citizen’s Health Research Group, told the FDA when he provided his CV that the CV could be made public without any redactions. Yet when the FDA posted it online, the agency redacted it anyway.
“The agency redacted my military awards and service and the amount of one National Kidney Foundation grant long since closed out,” said Carome. “The notion that releasing this information would be an invasion of privacy or that it was confidential would be hard to understand anyway – but after I specifically had stated that the CV could be posted in full, it is ridiculous.”
Believing the redactions to be unjustified, Public Citizen filed suit to obtain unredacted copies of the CVs posted on the FDA’s website. Public Citizen also seeks an order requiring the FDA to post unredacted copies of the CVs on its website going forward, because FOIA requires agencies to post frequently requested records online and the FDA’s website concedes that advisory committee members’ CVs are frequently requested.
The FDA claims that these redactions protect confidential and private information, but CVs are compiled by individuals specifically for the purpose of touting their backgrounds and accomplishments. Each person chooses what information to include and how to state it on her own CV.
“Confidential information does not appear on documents crafted for the express purpose of sharing with other people,” said Rachel Clattenburg, the lead Public Citizen attorney on the case. “The redactions are unjustified and show that the FDA has wasted considerable time going through CVs to black out information. We worry that the FDA’s treatment of advisory committee member CVs is an indication that the agency favors secrecy over disclosure.”