Review this exciting guide to some of the recent content additions to Practical Guidance, designed to help you find the tools and insights you need to work more efficiently and effectively. Practical Guidance...
By: Jeffrey D. Mamorsky , COHEN & BUCKMANN, P.C. THIS VIDEO SERIES CELEBRATES THE ENACTMENT of the Employee Retirement Income Security Act (ERISA), signed by President Gerald Ford on September 2...
By: Kirk A. Sigmon , BANNER WITCOFF THIS CHECKLIST OUTLINES KEY CONSIDERATIONS THAT ATTORNEYS should review when advising whether and how to copyright artificial intelligence (AI) and machine learning...
By: Erin Hanson , Arlene Arin Hahn , Sahra Nizipli , and Jordan Hill , WHITE & CASE LLP THIS ARTICLE SUMMARIZES VARIOUS INTELLECTUAL PROPERTY AND TECHNOLOGY (IP/IT) PROVISIONS, including sample definitions...
By: Damon W. Silver , Gregory C. Brown, Jr. , and Cindy Huang , JACKSON LEWIS P.C. Overview of Artificial Intelligence (AI) in Employment Decisions AI tools are fundamentally changing how people work...
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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:
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:
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:
With respect to actions taken by the FDA, the following are examples of final agency actions:
The following are examples of actions taken by the FDA deemed not to be final agency actions:
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.
Not yet a Practical Guidance subscriber? Sign up for a free trial to read the complete article.
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.
To find this article in Practical Guidance, follow this research path:
RESEARCH PATH: Life Sciences > Regulatory Enforcement > Articles
For an overview of practical guidance related to the U.S. Supreme Court’s recent decision overturning the Chevron doctrine, see
> CHEVRON REVERSAL IMPACT RESOURCE KIT
For an analysis of how Loper Bright will impact the IRS and taxpayers, see
> LOPER BRIGHT UPENDS JUDICIAL DEFERENCE: IMPLICATIONS FOR THE IRS, TREASURY, AND TAXPAYERS
For a discussion of the impact of Loper Bright on employers, see
> GO FISH! U.S. SUPREME COURT OVERTURNS ‘CHEVRON DEFERENCE’ TO FEDERAL AGENCIES: WHAT IT MEANS FOR EMPLOYERS
For a look at how administrative agencies and courts will be affected by the Loper Bright ruling, see
> CHEVRON DOCTRINE OVERRULED: U.S. SUPREME COURT UPENDS LONGSTANDING FOUNDATION OF ADMINISTRATIVE LAW
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).