Standard Operating Procedures for Federal Agencies ?

Public Citizen Sues FDA Over Redacted Advisory Committee Info

The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency’s practice of redacting information in the curricula vitae (CV) of its advisory committee members.

Public Citizen alleges that the redactions mask information about these outside experts that could reveal potential biases and provide relevant background on their professional qualifications, according to a complaint filed to the US District Court of the District of Columbia on Wednesday.

The Complaint

In its complaint, Public Citizen calls FDA’s practice of redacting the CVs “arbitrary and capricious,” and claims that the agency is failing to proactively disclose the documents under the Freedom of Information Act (FOIA).

Specifically, the group believes that FDA’s reasoning for redacting the CVs does not meet the criteria of any of nine FOIA exemptions for redacting information.

According to Public Citizen, around 90% of the CVs posted to FDA’s website for its advisory committee members contain redactions (Center for Drug Evaluation and Research, 92%; Center for Biologics Evaluation and Research, 86%; Center for Devices and Radiological Health, 98%).

Public Citizen says it first raised the issue to FDA in a letter dated 4 February 2014. Public Citizen says that Sarah Kotler, who was then FDA’s deputy director for the Division of Freedom of Information, responded by saying FDA’s policy is to “categorically redact” certain information in its advisory committee members’ CVs.

Advisory Committee Redactions

FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. The agency typically convenes an advisory committee meeting when it wants input on a new drug or device, or when it is looking into a specific safety issue for an approved product.

While FDA publishes advisory committee members’ CVs on its website, it frequently redacts information, such as “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colleagues and mentors, the amounts of grants received from private companies, and the names of presentations and unpublished articles.”

According to Dr. Michael Carome, director of Public Citizen’s Health Research Group, who sits on FDA’s Pharmacy Compounding Advisory Committee, the agency redacted his CV despite his request that it be made available without any redaction.

“The agency redacted my military awards and service and the amount of one National Kidney Foundation grant long since closed out,” he said. “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.”

One Response

  1. The definition of a free country just changed.

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