Freedom of Information

In handling Freedom of Information Act (FOIA) requests, the Food and Drug Administration (FDA) considers the withholding of certain information to be a "minor violation" rather than a denial and thus not immediately appealable. In addition, FDA regulations provide that when FDA is sued for release of information that it agrees consists of trade secrets, FDA will release the information unless the submitter intervenes to defend against disclosure. GAO found that while FDA has provided information on FOIA requests in a fairly timely manner, it needs to improve compliance. To be fully consistent with the law, FDA also needs to rescind its policies on minor deletions and private intervention in lawsuits. These policies lack a basis in law. Also, even though FDA's regulations have in effect been modified by superseding Health and Human Services regulations, it would be preferable for FDA to update its regulations on fee charges and predisclosure notifications to reflect changes made by FOIA. This change would help readers know which parts of the regulations remain in effect. FDA needs to (1) better account for costs under its FOIA program so that it can recover through its fee structure all allowable costs and (2) do better in providing 10-day notices to requesters to advise them of the status of their requests as contemplated by the law.

GAO found that: (1) two FDA regulations were inconsistent with FOIA, and other such regulations did not accurately reflect the current state of the law, even though they had been superseded by Department of Health and Human Services (HHS) regulations that did; (2) the FDA practice of precluding immediate appeals of minor deletions of information from documents and requiring the requester to make a second request for the deleted information is unauthorized by FOIA, but FDA believes that this practice benefits requesters by giving them releasable information more quickly; (3) the FDA policy of releasing trade secrets unless the submitter intervenes in a lawsuit seeking their release is inconsistent with laws expressly prohibiting the unauthorized release of such information by FDA; (4) FDA regulations did not incorporate changes made by FOIA amendments or an executive order regarding processing fees and predisclosure notifications; (5) although FDA has generally complied with predisclosure notification requirements, it may not be recovering all the FOIA costs to which it is entitled under the law; and (6) although the law did not set a time limit for providing information to a requester, in about 45 percent of the reviewed cases, FDA did not meet its 10-day notification requirement, but usually provided the information within 30 days.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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