Washington Wrap-Up: FDA, CDRH Keeping Secrets Despite Transparency Initiative

The Obama Administration swept into Washington in 2008 promising the most open government in history. That edict has been broadly ignored ever since, and FDA has continued to follow that trend. In June, CDRH posted premarket approval (PMA) summary review memos online with the reviewers’ names needlessly redacted. The memos, which were for 180-day design changes, were posted to the center’s transparency Web site, which was launched in an effort to comply with the transparency initiatives.

In an e-mail, FDA press officer Karen Riley explained that the agency had “elected” to redact the reviewers’ names, though she admitted that it had not been necessary to do so.

Most of the redactions were coded “(b)(6)." This is shorthand for a provision of the Freedom of Information Act (FOIA) that allows information to be withheld if releasing it would violate individuals’ privacy. For example, the Department of Defense has used the provision, known as Exemption 6, to protect the privacy and maintain the security of personnel following the terrorist attacks of Sept. 11, 2001. 

Asked about CDRH’s rationale for redacting its employees’ names, Riley acknowledged in her e-mail that Exemption 6 had been incorrectly cited in the posted documents.

“For information to be exempt from release under [Exemption 6], the standard is [that it] constitutes an unwarranted invasion of personal privacy,” Riley wrote. “Release of FDA employees’ names on our work products as public servants doesn’t meet that standard.”

She explained that when CDRH first began posting the documents, the office “acknowledged that… FDA employees are not entitled to anonymity when performing these duties…” but “after considering it, we elected to redact the reviewers' names for documents posted on the Web. Partway through the first year, we also began redacting some of the contact information for the sponsor's correspondent.”

“If any member of the public requests the records under FOIA,” Riley wrote, “that data will not be redacted. The requests can be processed quickly in the simple track, especially since we have the documents redacted and only need to restore the data regarding the reviewer and sponsor correspondent.”

Riley reiterated that CDRH should not have cited Exemption 6 in the documents. “We are not using any exemption,” she wrote, “because the information is not exempt from release; we are choosing not to post it on the Web.”

The bottom line appears to be this: Given the option, FDA would prefer to choose secrecy over transparency. In the case of these summary review memos, redacting the reviewers’ names deters uncontrolled contact between the reviewers and the public, making it easier for the agency to stay on message. The only recourse for anyone wishing to know the identity of a reviewer is to file a Freedom of Information Act request and wait.

CDRH employees visited my personal Web site (www.fdaweb.com) and posted comments questioning the importance of revealing reviewers’ names. Said one: “Reviewers are over-ruled by managers all the time but the managers are not required to enter a record of their decision.”

Agreeing, another said: “By the time my reviews see the light of day they include the opinions of everyone above me. Only when I disagree strongly with a manager's opinion do I refuse to make the changes," a scenario which, the commenter noted, is rare. "I believe that a hierarchy is required to get anything accomplished and accept that managers must make decisions that may differ from my opinion. But don’t let my name be the one the world sees as the responsible party when others' opinions are included in my final documents.”

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