HOUSTON
Volume 15 | Issue 11
Inside This Issue
Baylor College Of Medicine to Offer New Clinical Psychology Degree Program See pg. 9
INDEX Oncology Research......... pg.3 Hospital News................. pg.5&6 Healthy Heart....................... pg.7 Age Well, Live Well.......... pg.10 Financial Forecast............ pg.12
From Military Service to Expert Care at St. Lukes’ Health See pg. 11
November Edition 2025
FDA Takes Aim at Drug Ads: What It Means for Compounding Pharmacies, Medspas and Telehealth Companies
By Stuart M. Pape, J.D. Suzanne E. Bassett, J.D. Polsinelli, PC
T
he U. S. F o o d a n d D r u g Administration (FDA) recently launched its most sweeping crackdown on direct-to-consumer (DTC) advertising in years. As part of the Trump Administration’s effort to address misleading DTC prescription drug advertisements, FDA sent thousands of notices and nearly 100 cease-and-desist letters to companies it says are running misleading drug ads. While some went to several major pharmaceutical companies the vast majority were directed at compounding pharmacies, medical spas and telehealth platforms — including well-known companies like Hims & Hers — for their purportedly misleading claims about compounded GLP-1 products. This wave of compliance activity is unprecedented, not just in volume, but also in focus. In recent years FDA has only issued a handful of warning letters targeted at prescription drug advertisements. Now, the agency is signaling a sharp reversal. And, it has swept in online telehealth platforms that are arguably outside FDA’s jurisdiction — indicating a willingness to test the limits of its authority. FDA Jurisdiction Over Telehealth Companies Digital health platforms have
long operated in a regulatory gray zone regarding FDA enforcement. FDA’s enforcement authority under the Federal Food, Drug, and Cosmetic Act (FDCA), is typically limited to “prohibited acts” related to developing, manufacturing, distributing, selling, marketing, holding for sale and labeling regulated products. FDA-approved prescription drugs also have restrictions on DTC advertising, including that all ads must provide a fair balance between information on side effects and contraindications and information on the drug’s effectiveness. However, most telehealth platforms don’t engage in these traditionally FDA-regulated activities. Instead, they connect consumers to independent licensed telehealth providers, who prescribe compounded GLP-1s that are then filled at independent compounded pharmacies, usually at a steep discount to FDA-approved versions. Compounded drug products do not have an FDA-approved label and are expressly exempt from certain advertising rules required of their branded counterparts.
Enforcement Push Reaches Telehealth Platforms However, this did not stop FDA Commissioner Martin Makary from specifically criticizing Hims & Hers’s Super Bowl ad as a “brazen” violation of FDA’s fair and balanced regulations in a JAMA Viewpoint article published a few days after the enforcement sweep. But the warning letter issued to Hims & Hers and similar companies told a narrower story. It didn’t cite the Super Bowl ad or raise fair-balance concerns. Instead, it only alleged misbranding violations for claims that implied the compounded products were FDA-approved, when they are not — for example, that they contain the “same active ingredient as Ozempic and Wegovy” and that the ingredients are “clinically proven.” Compounded Drugs, Unclear Rules and a Compliance Catch-22 This disconnect exposes a deeper regulatory tension. Compounded drugs, by definition, are not FDA-approved. They therefore lack an FDA-approved label — meaning they have no official see Drug Ads ...page 14
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