Chapter 7.D.1: The FDA, Pharmaceutical Regulation, and the Constitution

NOTES: THE SCOPE AND CONSTITUTIONALITY OF PHARMACEUTICAL REGULATION (pp. 694-701)

2. The Drug Approval Process and Access to Experimental Therapies.  In April 2026, President Trump issued an executive order designed to facilitate research on the therapeutic use of psychedelic drugs.  See Andrew Jacobs & Noah Daly, Trump Loosens Restrictions on Psychedelic Drugs, N.Y. Times, April 17, 2026 (discussing executive order and history of FDA actions relating to psychedelics). 

5. Drug Labeling, “Off-Label Use,” and the Learned Intermediary Doctrine. The FDA issued guidance on off-label communications in 2025.  Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Products: Questions and Answers; Guidance for Industry, 90 Fed. Reg. 1146 (Jan. 7, 2025).  Government speech has also generated litigation. See Apter v. Department of Health & Human Services, 80 F.4^th 579 (5th Cir. 2023) (permitting physicians to pursue claims that the FDA exceeded its authority by issuing social media posts discouraging consumers from taking Ivermectin for COVID-19).

6. Direct-to-Consumer (DTC) Advertising.  In 2025, the FDA announced a “crackdown” on deceptive DTC advertising.  FDA, FDA Launches Crackdown on Deceptive Drug Advertising (Sept. 9, 2025), available at: https://www.fda.gov/news-events/press-announcements/fda-launches-crackdown-deceptive-drug-advertising. 

Expanded Note 7. The FDA and New Regulatory Challenges: From Tobacco and Medical Apps to Mifepristone.  

            Tobacco.  See also FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542 (2025) (unanimous decision upholding FDA’s denial of premarket tobacco product applications for flavored e-cigarette liquids against challenge based on agency’s allegedly arbitrary and capricious change of position; case remanded for determination of whether FDA’s failure to review marketing plans was harmless); R. J. Reynolds Tobacco Company v. Food & Drug Administration, 96 F.4^th 863 (5^th Cir. 2024) (upholding FDA’s graphic warning rule for cigarette packages and advertisements as purely factual, uncontroversial, and not unduly burdensome), cert. denied, 145 S. Ct. 592 (2024). 

            Medical Apps and AI.  The FDA issued revised guidance governing AI and medical devices in 2025.  See U.S. Food & Drug Administration, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Aug. 2025), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence. 

            Mifepristone.  Mifepristone used for abortion was approved by the FDA in 2000 and the FDA has loosened restrictions on prescribing and dispensing over time.  In states that permit abortion, more than half the abortions are carried out through medication.  Guttmacher, Medication Abortion (as of July 1, 2026), available at https://www.guttmacher.org/state-policy/explore/medication-abortion. The medication raises many potential legal claims. See generally David S. Cohen, Greer Donley & Rachel Rebouché, Abortion Pills, 76 Stan. L. Rev. 317 (2024). Some physicians, medical groups, and states have sought to limit access to Mifepristone.  See, e.g., FDA v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024) (Supreme Court unanimous in holding that physicians and medical groups lacked Article III standing to challenge FDA’s relaxation of prescribing and dispensing rules). A separate challenge to the FDA’s rules and policies allowing telemedicine prescriptions and mail delivery led to a temporary stay of the FDA’s policies issued by the Court of Appeals for the Fifth Circuit. Louisiana v. Food & Drug Administration, 175 F.4^th 310 (5^th Cir. 2026). The Supreme Court stayed the Fifth Circuit’s order.    Danco Laboratories, LLC v. Louisiana, 608 U.S. __, 146 S. Ct. 1192 (2026) (with separate written dissents by Justices Thomas and Alito).  For a discussion of the legal and political landscape, see Pam Belluck & Sheryl Gay Stolberg, Abortion Pill Lawsuit Leaves Trump Silent, and in a Political Bind, N.Y.Times,  May 18, 2026.  The Court of Appeals for the Fourth Circuit considered and rejected an effort by a different set of plaintiffs to argue that the FDA rules governing mifepristone preempted West Virginia’s state abortion ban.  GenBioPro, Inc. v. Raynes, 144 F.4^th 258 (4^th Cir. 2025).