The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule would amend FDA’s regulations to reflect updated Federal requirements for information access, clarify certain provisions of FDA’s information access regulations, and make the FOIA process easier for the public to navigate. The agency anticipates that these changes, taken together, will enhance transparency for the public with regard to FDA activities.
FOIA is a law that gives the public the right to access information from the Federal government. There is a presumption that government records must be released under FOIA unless they are subject to an exemption. In this regard, FDA is proposing to amend its regulations to state explicitly that the agency would withhold information under FOIA only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption or disclosure is prohibited by law.