Chevron Deference Reversal: FDA Rulemaking and Legal Challenges After Loper Bright

By: Chad A. Landmon and Suzanne E. Bassett, POLSINELLI PC

THIS ARTICLE PROVIDES GUIDANCE ON THE IMPACT of the U.S. Supreme Court’s recent decisions in Loper Bright¹ and Corner Post² on decision-making by the U.S. Food and Drug Administration (FDA). 

By Overruling Chevron³ deference to statutory interpretations made by federal agencies, the Supreme Court has likely opened the floodgates for legal challenges to regulations promulgated by the FDA and to final decisions rendered by the FDA. Regulated industries must be mindful of this new legal paradigm when advocating before the agency, in addition to being ready for the court challenges that will undoubtedly be initiated.

This article discusses the following topics:

• Federal court jurisdiction under the Administrative Procedure Act
• Agency deference
• Loper Bright and Corner Post
• Industry best practices

Federal Court Jurisdiction under the Administrative Procedure Act

Administrative Procedure Act

Section 702 of the Administrative Procedure Act (APA)⁴ grants federal courts jurisdiction to review actions taken by executive branch agencies.

Section 706 of the APA⁵ states that the “reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action.”

Further, Section 706 directs reviewing courts to “compel agency action unlawfully withheld or unreasonably delayed”⁶ and to “hold unlawful and set aside agency action, findings, and conclusions” that are:

• Arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law
• Contrary to constitutional right, power, privilege, or immunity
• In excess of statutory jurisdiction, authority, or limitations, or short of statutory right
• Without observance of procedure required by law
• Unsupported by substantial evidence in a case concerning formal rulemaking and adjudicatory proceedings or otherwise reviewed on the record of an agency hearing provided by statute
• Unwarranted by the facts⁷

Defining a Final Agency Action

Judicial review under the APA is limited to final agency actions. For an agency action to be final, and thus subject to judicial review, the action must:

• Mark the end of the agency’s decision-making process, rather than a tentative or interlocutory action⁸
• Determine rights or obligations, or result in legal consequences⁹

With respect to actions taken by the FDA, the following are examples of final agency actions:

• A response to a citizen’s petition¹⁰
• Interpretation of a statute that causes an Abbreviated New Drug Application applicant to lose its 180-day exclusivity¹¹
• Enforcement of the Federal Food, Drug, and Cosmetic Act through administrative procedures¹²
• Issuance of rules and regulations through notice and comment rulemaking¹³

The following are examples of actions taken by the FDA deemed not to be final agency actions:

• Issuance of a notice of proposed rulemaking where the notice proposed a ban on an additive but stated that it would take no action¹⁴
• Statements made in a preamble to final regulations¹⁵
• Threats made during an in-person meeting to seize mislabeled products¹⁶

Agency Deference

Section 706 of the APA¹⁷ authorizes a court to “hold unlawful and set aside agency action” that it finds “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.” As a result, the APA makes judges the decision-makers of all questions of law properly before them and contemplates some level of deference if the agency’s interpretation of the statute is reasonable (i.e., not arbitrary, capricious, or an abuse of discretion).

To effectively carry out their statutory responsibilities, courts have created doctrinal tests to determine whether to give an agency’s interpretation of a statute or regulation any deference.

For additional practical guidance related to Chevron, Auer, and Skidmore deference, plus analysis of the impact of the recent Loper Bright and Corner Post decisions, subscribers please follow this link to read the complete article in Practical Guidance.

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FDA May Slow Down Rulemaking and Use Other Tools at its Disposal

With more tools for companies to challenge FDA rulemaking, it is possible that FDA-regulated companies will see a slowdown in FDA rulemaking as the agency must now consider whether there is another permissible statutory interpretation. With less incentive to rely on the rulemaking process, the FDA may also rely more heavily on guidance documents, which do not carry the force of law, or individual enforcement actions against specific companies or products.

As time progresses, it will be increasingly important to monitor the FDA landscape and any changes the agency takes to its regulatory approach. 

Chad A. Landmon chairs Polsinelli’s Hatch-Waxman & Biologics Practice and is a first chair trial lawyer known for his adept handling of both patent litigation and the FDA approval processes, ensuring clients can efficiently and profitably bring their products to market. He is recognized globally as a leading patent litigator by IAM Patent 1000, Benchmark Litigation, and Law360, and has successfully litigated more than 60 cases in the past decade alone.

Suzanne E. Bassett, an associate at Polsinelli, counsels clients on compliance, enforcement, and transactional matters subject to overlapping jurisdictions of the FDA, U.S. Department of Agriculture, the Federal Trade Commission, and the U.S. Consumer Product Safety Commission. Suzanne’s experience also extends to matters involving the U.S. Drug Enforcement Administration, U.S. Customs and Border Protection, and various state and municipal agencies.

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Related Content

1. Loper Bright Enters v. Raimondo, 144 S. Ct. 2244, 219 L. Ed. 2d 832 (2024). 2. Corner Post, Inc. v. Bd. of Governors of the Fed. Rsrv. Sys., 144 S. Ct. 2440, 219 L. Ed. 2d 1139 (2024). 3. Chevron, U.S.A., Inc. v. NRDC, 467 U.S. 837, 104 S. Ct. 2778, 81 L. Ed. 2d 694 (1984). 4. 5 U.S.C.S. § 702. 5. 5 U.S.C.S. § 706. 6. 5 U.S.C.S. § 706(1). 7. 5 U.S.C.S. § 706(2). 8. See Bennett v. Spear, 520 U.S. 154, 178 (1997). 9. See Port of Boston Marine Terminal Ass’n v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71 (1970). 10. See Ranbaxy Labs., Ltd. v. Burwell, 82 F. Supp. 3d 159 (D.D.C. 2015). 11. Teva Pharm. USA, Inc. v. Sebelius, 638 F. Supp. 2d 42 (D.D.C. 2009), rev’d, 595 F.3d 1303 (D.C. Cir. 2010). 12. See Health Sci. Funding LLC v. FDA, 2016 U.S. Dist. LEXIS 70529 (D.N.J. May 31, 2016). 13. See Ohio v. United States, 154 F. Supp. 3d 621, 631 (S.D. Ohio 2016). 14. See Pub. Citizen v. Bowen, 833 F.2d 364, 366 (D.C. Cir. 1987). 15. See U.S. v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248, 261–62 (D.D.C. 2012) (citing 21 C.F.R. § 10.85(d)(1) and (j) (stating that a preamble constitutes an advisory opinion and not “a legal requirement”). 16. See Health Sci. Funding LLC v. FDA, 2016 U.S. Dist. LEXIS 70529 (D.N.J. May 31, 2016). 17. 5 U.S.C.S. § 706(2)(A). 18. Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. at 842–43. EPA v. EME Homer City Generation, L.P., 572 U.S. 489, 512 (2014). 19. See United States v. Mead Corp., 533 U.S. 218, 221 (2001).