FDA Seeks to Toss Lawsuit From Company Lawyer Seeking Anonymity in Facility-Inspection Report

The attorney argues that being linked to the report, which stems from 20 FDA site visits in the spring of 2022, could cause reputational harm and derail the attorney's career.

By Chris O’Malley, Law.com, Aug. 14, 2023

What You Need to Know

• The Food and Drug Administration said the attorney does not have a solid legal basis to remain anonymous.

• A judge in May had temporarily permitted anonymity.

• At issue is what can be disclosed in a Form 483, a report that is the first step in a potential enforcement action.

The U.S. Food and Drug Administration is scoffing at a “Doe” lawsuit filed by a company attorney trying to prevent being identified in an agency inspection report on the grounds disclosure would cause irreparable harm to the lawyer’s reputation and career.

The unusual “reverse FOIA” case, is based on flimsy legal arguments that don’t come close to meeting the narrow public-disclosure exceptions contained in the Food, Drug and Cosmetic Act, the agency asserts in a recently filed motion to dismiss.

“A plaintiff in a reverse-FOIA suit cannot rely on FOIA exemptions to prevent an agency from disclosing information, for the basic reason that FOIA is exclusively a disclosure statute,” the FDA said recently in response to the suit, which was brought in the U.S. District Court for the District of Columbia.

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