Judicial Review of the Legality of FDA’s Decision to Withhold the Withdrawal Process

A. The District Court's Ruling on the Permissibility of FDA's Delay of Engaging in Withdrawal of Antibiotic Drugs

The FDA’s decision not to pursue regulatory actions against antibiotic drug manufacturers has met some legal challenges.

The main contentious issue faced by the court is to decide whether the FDA remains bound by the law to continue the withdrawal proceedings, including holding hearings and making final withdrawal orders accordingly, even though the initial NOOHs were rescinded.

Both parties disputed the legal and procedural mandates of the FDCA in § 360b(e)(1), which governs the withdrawal of approval of NADAs. The statute underlines four steps to finalize the withdrawal procedure: (1) the release of an unsafe finding, (2) the issuance of notice for hearings, (3) the holding of public

Phasing Out Antibiotics in Food Animals 23 hearings for affected sponsors, and (4) the ordering of the withdrawal of appli­cation if the sponsors fail to demonstrate the safety of the drugs.

The FDA took a narrow view of the procedure and contended that the law requires the withdrawal only after hearings are held. Since it never held hear­ings and has already withdrawn the 1977 NOOHs, the FDA argued that no further action was required. By contrast, the plaintiffs claimed that the original findings that the use of antibiotics on farm animals was not safe shall sufficiently oblige the FDA to engage in a withdrawal procedure.⁶¹

The court agreed with the position of the plaintiffs, whose interpretation was “based on its text and grammatical structure”⁶² of the law.

Indeed, the FDA has rescinded the 1977 NOOHs. The move, the court con­sidered, would not affect the obligation of the FDA to complete the withdrawal proceedings as long as the unsafe findings remain.⁶⁵ The court, in reviewing the FDA’s recent announcement in rescinding the notice, found that the FDA remains concerned about the health problem of using antibiotics in animal feed, and the agency has not yet rescinded its original findings.⁶⁶

Finally, although the FDA opted for other regulatory strategies—namely the voluntary approach of phasing out certain antibiotics—the court ruled that the new approach “does not relieve it of its statutory obligation to complete with­drawal proceedings.”⁶⁷ The court found that “[t]he statute does not empower the agency to choose a different course of action in lieu of withdrawal proceedings, such as that embodied in the 2010 Draft Guidance.”⁶⁸

B. The Appellate Decision Deferring to FDA's Interpretation

In contrast to the opinions of the district court, the appellate court considered that the FDCA does not explicitly mention when the alleged “finding” hap­pens. The court found that the interpretations by the two parties seem feasible, as the sequence of the withdrawal process is unclear by a reading of the text.

By examining the text, context, and regulations for implementing the law, the court decided to sustain the interpretation of the FDA, which argued that a finding can only be made after a hearing about the safety of the drugs has been concluded.

Apart from using the previous interpretation techniques, the court’s favor­ing of the position of the FDA follows on its analysis of background legal concepts.^[76] Unless Congress has a clear mandate, the court maintained that its interpretation should not depart from conventions regarding administrative procedure. It held that the FDA interpretation is consistent with conventional wisdom.

First, the FDA’s position is in accordance with the general understanding of the administrative decision, which normally reflects the result of the final deliberations and would not be made until the conclusion of the process. The practice aligns with other legislation, such as the Social Security Act and the Federal Rule of Evidence.^[77]

Second, the court recognized the significant impact of withdrawing a mar­keting approval. Thus, it agreed with Congress that the withdrawal should hinge on a relatively cautious hearing that allows evidence from both sides to be presented. A contrary view was considered unorthodox by the court.^[78]

Third, referring to civil and criminal procedures, the court found that the preliminary conclusion should not constitute and dictate the final decision, which is subject to the court’s final confirmation. By the same token, any charge against the affected party during an administrative procedure cannot lead to a final finding until the hearing process has been concluded.^[79]

Fourth, the court questioned the interpretation of the plaintiff, considering there was no indication of a formal unsafe reference, given that the original NOOH had been withdrawn.^[80]

Fifth, probably the most important factor sustaining the FDA’s stance is the traditional recognition of the discretion enjoyed by agencies. The court noticed that agencies have a variety of duties and limited resources. This is a very important and difficult decision in terms of deciding how and when resources will be used. The agency should enjoy the discretion of setting the priority for implementing the law.^[81]

VI.