Regulatory Focus™ > News Articles > Group: FDA's Interpretation of FOIA Procedures Illegal

Group: FDA's Interpretation of FOIA Procedures Illegal

Posted 19 September 2012 | By Alexander Gaffney, RAC 

The public health advocacy group Public Citizen is blasting the US Food and Drug Administration (FDA) for its application of the Freedom of Information Act (FOIA), saying in a statement that the agency's actions violate both the "letter and spirit" of the law.

FOIA, passed in 1966, has been dramatically expanded over the last half century to include numerous provisions requiring federal agencies to release documents relating to many internal decision-making processes. The law is frequently used by media organizations as part of their investigative reporting, but companies and third-party organizations also use the law to search for particular documents, such as all warning letters released by FDA during a particular quarter.

The problem, claims Public Citizen, is FDA's regular and longstanding use of redacting procedures-"Minor Deletions"-while denying FOIA requesters the right to appeal the deletion to the agency.

"This practice violates FOIA," remarked Public Citizen.

FDA's use of the deletions represents a clever loophole in the FOIA law. Because the redactions of minor details in a requested document do not represent an outright denial-at least not in a formal sense-the person or entity requesting the document is unable to appeal FDA's redactions through regular channels. Instead, the requester is required to submit a request for "reconsideration."

Public Citizen argues that this is problematic for several reasons. Among the most obvious: "minor deletion" is not a legally defined term, and in practice has constituted everything from the deletion of a single word to the redaction of entire pages of documents. Public Citizen argues the policy as a whole constitutes a "blatant violation of FOIA," and forces requesters through an arduous process relative to a more streamlined one mandated by Congress.

The group also rapped FDA for classifying documents with minor deletions as "full releases," thereby padding its FOIA response numbers, and for ignoring previous reports by the Government Accountability Office (GAO) advising the agency to do away with the process.

Public Citizen has outlined its complaints in an extensive Citizen Petition, which calls for an end to the use of the policy and a revision of FDA's staff manuals to prevent it from happening in the future.


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