FDA After Chevron

• Published date: 14 March 2024
• Subject Matter: International Law, Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Energy and Natural Resources, Oil, Gas & Electricity, International Trade & Investment, Trials & Appeals & Compensation, Food and Drugs Law
• Law Firm: Axinn Veltrop & Harkrider
• Author: Chad A. Landmon, Aaron Z. Savit, PhD and Ian Swan

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). In recent years, however, the Supreme Court has hinted at a shift away from Chevron. Several recent cases addressing agency interpretations have ignored Chevron entirely. See, e.g., American Hosp. Ass'n. v. Becerra, 142 S. Ct. 1896 (2022). And, in January of 2024, the Supreme Court heard two cases challenging Chevron's viability, raising expectations that the doctrine will be overturned or significantly curtailed. See Loper Bright Enters. v. Raimondo, No. 22-451 (U.S.); Relentless, Inc. v. Dep't of Commerce, No. 22-1219 (U.S.).

Many lower courts have likewise moved away from Chevron and instead have more strictly applied "traditional tools of statutory interpretation." American Hosp. Ass'n., 142 S. Ct. at 1906. With many jurists and industry players advancing a narrower deference doctrine, it is time to consider what limiting or eliminating Chevron may look like for the Food and Drug Administration and the industries it regulates.

Here, we briefly examine Chevron's impact on FDA before discussing what types of FDA decisions may be subject to greater scrutiny if Chevron is narrowed or overturned. The industries that FDA regulates will certainly need to be prepared for tackling FDA issues - and tackling FDA itself - in a post-Chevron or Chevron-lite world.

Chevron's Impact on FDA

The Food, Drug, and Cosmetic Act (FDCA) empowers FDA to make regulations that have the force of law provided that they are subject to public notice and comment. But FDA often treats informal guidance documents, letter rulings, and policy statements'which are not subject to notice and comment'as equally binding. FDA thus tends to exert far more authority in practice than the letter of the law would suggest.

Under Chevron, courts have regularly upheld FDA's statutory interpretations. For example, in Athenex v. Azar, the court upheld FDA's standard for nominations to its bulk substance list, rejecting a challenge to the agency's interpretation of "clinical need" as used in Section 503B of the FDCA. 397 F. Supp. 3d 56, 63-74 (D.D.C. 2019).

Similarly, the court in Sanofi-Aventis U.S. v. Food and Drug Administration adopted FDA's interpretation of the "full description" requirement of 21 U.S.C. ' 355(b)(1)(D), which allowed FDA to require immune response data as part of an abbreviated new drug application. 842 F. Supp. 2d 195, 210 (D.D.C. 2012). It likewise upheld as reasonable the FDA's five-pronged approach to determining active ingredient "sameness" for proposed generic drugs. Id. at 212-14.

These cases are two of the many examples in which Chevron has allowed FDA's statutory interpretations to carry the day. By directing courts to defer to any reasonable agency interpretation of an ambiguous statutory provision, Chevron often gives broad discretion to FDA. Eliminating or scaling back Chevron would thus expose FDA's decisions and interpretations to greater judicial scrutiny.

Likely Challenges to FDA Decisions

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