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# Dismissal Sought in FDA-483 Anonymity Suit
- URL: https://www.fdaweb.com/dismissal-sought-in-fda-483-anonymity-suit/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154952

FDA says that a “reverse-FOIA \[Freedom of Information Act\]” lawsuit seeking to keep an unnamed company attorney’s identity secret ([see earlier story](https://www.fdaweb.com/attorney-sues-fda-to-keep-name-off-fda-483/)) in connection with a form FDA-483 should be dismissed because the suit failed to state a claim for which relief can be granted. The [suit](https://fingfx.thomsonreuters.com/gfx/legaldocs/jnpwyoazkpw/Cooley-lawsuit-FDA-2023-05-16.pdf?ref=fdaweb.com), which lists J. Doe as the attorney, says the agency intended to publish the FDA-483 “despite plaintiff’s detailed explanation to FDA as to why plaintiff’s identity should be redacted, given that the release of plaintiff’s identity is unnecessary, contrary to law, inconsistent with agency precedent, and harmful to plaintiff.”

In a just-posted [FDA response](https://fingfx.thomsonreuters.com/gfx/legaldocs/znvnzezwxvl/Doe%20v%20FDA%20-%20motion%20dismiss%20-%2020230724.pdf?ref=fdaweb.com) to the complaint, the agency argues that 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.’ FOIA exemptions allow agencies to withhold certain information, but they don’t require it. So a case brought under the Administrative Procedure Act (‘APA’) to prevent disclosure must cite some non-FOIA authority that bars disclosure of the information at issue. Plaintiff fails to do so.”

FDA’s response contends that the plaintiff’s complaint is based on FOIA Exemptions 6 and 7(C) and only “tangentially” cites the statute that governs FDA inspections. “But the complaint cites nothing in the FDCA \[Food, Drug & Cosmetic Act\], or in FDA regulations, that bars FDA from releasing plaintiff’s job title in the Form FDA 483,” the agency says, adding that the complaint should therefore be dismissed.

The response further notes that even if plaintiff’s claim could rest on the FOIA, it would still “fail to state a claim for which relief can be granted. Plaintiff has not plausibly pled a substantial privacy interest that would be harmed by the disclosure of plaintiff’s job title in the Form FDA 483, the threshold requirement for the applicability of FOIA’s privacy exemptions.”