Posted 05 February 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is being unnecessarily opaque with some information related to its advisory committee members, a prominent consumer group charged this week.
In addition to FDA's own regulatory staff, it is assisted in its review of new medicines and regulatory decision making by advisory committees composed of subject matter experts. Those committees give FDA advice that, while non-binding, is followed by the agency in the majority of cases.
In accordance with legislation, those committee members must disclose all conflicts of interests along with a full curriculum vitae (CV) describing their work history in depth.
However, only some of these details are ever seen by the public. Most financial disclosure documents are, for example, redacted to ensure that an advisory committee member is not subject to identity theft.
Don't See the CV
But as the public advocacy group Public Citizen charged this week, FDA's redactions sometimes go too far, and unnecessarily so.
In a letter sent to FDA Commissioner Margaret Hamburg and Chief Counsel Elizabeth Dickinson, Public Citizen's Sidney Wolfe and Allison Zieve alleged that many of FDA's redactions are "unjustified under the Freedom of Information Act (FOIA)."
Specifically, Wolfe and Zieve said that FDA often redacts large parts of advisory committee members' CVs.
"Of the 180 CVs posted for members of Center for Drug Evaluation and Research (CDER) advisory committees as of January 29, 2014, 167 have redactions-93 percent," they wrote. The Center for Biologics Evaluation and Research's (CBER) advisory committees had redaction rates of 94%, while all of the Center for Devices and Radiological Health's (CDRH) committee members' CVs had redactions, they found.
"The redactions appear to be wholly unwarranted by any legitimate need or the FOIA exemptions on which they purportedly are based," Wolfe and Zieve wrote.
The group advances two arguments in its letter.
The first is that information contained on a CV cannot, "almost by definition," contain a trade secret or be confidential as it is intended to be shown to others. Despite this, "Many are redacted with that designation," even though some of the information is reportedly decades old.
In some cases, Public Citizen said it was able to find publicly available copies of the same CVs elsewhere, such as on LinkedIn, further eroding FDA's secrecy argument.
The second argument is that FDA's "confidential" information exemption, used to protect financial or private information, is being misused. Public Citizen said this should relate only to things like medical information.
"On its face, the notion that a rational person would include on her CV information that satisfies this standard is hard to fathom," the group wrote, noting that it was again able to find some of the redacted information on LinkedIn.
So what were some of the things FDA redacted under the FOIA exemptions? Wolfe and Zieve found instances where FDA redacted paper presentations, funded grants and contracts, publicly available license numbers, and even that one committee member had trained in Reiki, an alternative medicine practice.
"The CV redactions are troubling for several reasons," the letter argues. "First, they appear to be completely unjustified by the FOIA exemptions on which they are purportedly based and, for that reason, suggest a lack of training within the agency as to the scope of FOIA exemptions."
"[A] great many CVs are redacted with no indication of why," they added, "making it difficult even to say what erroneous rationale was guiding the agency when it redacted the CVs."
The disclosures contributed to a sense that the agency "favors secrecy over disclosure," and that FDA was wasting resources in making unnecessary redactions, the letter concluded.
The group called for the prompt "unredacting" of the CVs and a retraining of FDA staff on "the proper approach to FOIA."
Public Citizen's Letter