Summary: 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.
