Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT —S.D. Fla.: Pharmaceutical company’s action seeking declaratory, injunctive relief against FDA may proceed, (Feb 3, 2026)

By Sara Cracau, J.D.

The company sought declaratory and injunctive relief to rescind warning letters issued by the FDA.

A federal district court in Florida has denied the motion to dismiss of the FDA finding that the amended complaint alleged sufficient facts to support the pharmaceutical company’s claim of standing to challenge the FDA’s issuance of the warning letters and refusal to rescind same. The pharmaceutical company sufficiently alleged an injury-in-fact as it contended that it suffered economic harm in the form of “loss of business and revenue” which resulted from Yale University’s cancellation of all orders for drug products. Furthermore, the company alleged that because of the improperly issued warning letters, the notices caused a loss of business and revenue. Finally, the court found that the pharmaceutical company’s requested relief, in the form of declaratory and injunctive relief, would redress the company’s alleged economic harm for purposes of standing. In addition, the court reasoned that the FDA’s refusal to rescind the warning letters, as requested by the pharmaceutical company in the citizen petition, constituted final agency action and, therefore, the pharmaceutical company stated a cognizable claim (Hybrid Pharma LLC v. FDA No. 24-62413-CIV DAMIAN (S.D. Fla. Jan. 29, 2026)).

Warning letters. A pharmaceutical company filed a complaint pursuant to the Administrative Procedure Act (APA) challenging the decision of the FDA to issue two warning letters and sought declaratory and injunctive relief. The court initially granted in part the FDA’s motion to dismiss the complaint finding that the pharmaceutical company failed to demonstrate an injury-in-fact that was traceable to the agency action as required to establish standing. The court granted the pharmaceutical company leave to amend the complaint. Thereafter, the company which specializes in compounding and dispensing pharmaceuticals to mitigate drug shortages and fill specific needs for various providers and for clinical trials, filed its amended complaint. After two inspections, the FDA issues two separate warning letters. The pharmaceutical company contended that these letters “substantially affect” clinical trials in that they delay the progress and completion of the trials. Consequently, it submitted a citizen petition requesting that the FDA rescind its 2018 and 2022 warning letters, arguing that the agency had failed to follow its own policies and procedures. Such letters are published on the FDA’s website and, according to the pharmaceutical company, “have a devastating effect” causing economic damage, including loss of business and revenue. Furthermore, in this instance, the letters allegedly caused Yale University to stop and put an indefinite hold on a clinical trial.

Article III standing. The court found that the amended complaint alleged sufficient facts to support the pharmaceutical company’s claim of standing to challenge the FDA’s issuance of the warning letters and refusal to rescind same. Firstly, the pharmaceutical company sufficiently alleged an injury-in-fact as it contended that it suffered economic harm in the form of “loss of business and revenue” which resulted from Yale University’s cancellation of all orders for drug products. The State of Washington denied a business license which, in turn, caused the company to lose an order and revenue. Such harm is recognized as an injury for purposes of Article III standing. Regarding the causation requirement, the company alleged that because of the improperly issued warning letters, the notices caused a loss of business and revenue. The clinical trial with Yale University was forced to stop and placed on indefinite hold. As a direct consequence of such stoppage and indefinite hold, Yale University cancelled all pending and future orders for drug products with the company causing a loss of business and revenue. The court accepted the allegations as true at the pleading stage and found that a fair inference can be made that the FDA’s issuance of the warning letters and its refusal to rescind the letters as requested negatively affected the company’s business in the drug compounding industry. Finally, the court found that the pharmaceutical company’s requested relief in the form of declaratory and injunctive relief, would redress the company’s alleged economic harm for purposes of standing.

Plausible claim. The court found that the FDA’s refusal to rescind the warning letters, as requested by the pharmaceutical company in the citizen petition, constituted final agency action and, therefore, the pharmaceutical company stated a cognizable claim. The court found that the FDA’s decision to decline rescinding the warning letters as requested by the pharmaceutical company in the citizen petition, constituted final agency action, and that, therefore, the company had a cognizable claim under the APA. The court rejected the FDA’s contention that the warning letters were not final agency action within the meaning of the APA’s judicial review provision. The APA authorizes judicial review of final agency action by a “person suffering a legal wrong because of [that] agency action, or adversely affected or aggrieved by [the] agency action.” The U.S. Supreme Court remarked that Section 702 of the APA “equips injured parties with a cause of action” whereas Section 704 “limits the agency actions that are subject to judicial review.” A citizen petition provides a vehicle for a citizen to request an agency to issue, amend, or revoke a regulation or order to take or refrain from taking an administrative action.

The case is No. 24-62413-CIV-DAMIAN.

Judge: Damian, M.

Attorneys: Matthew Martin Fischer (Matthew M. Fischer, P.A.) for Hybrid Pharma LLC. James W. Harlow, U.S. Department of Justice, for Food and Drug Administration.

Companies: Hybrid Pharma LLC; Food and Drug Administration

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