A Blast From the Past: FDA's Recurring Commercial Speech Problem

(Posted Sept. 22, 2026, on LinkedIn)

The world of prescription drug advertising is indisputably a world unto itself, but both the Department of Health and Human Services and FDA seem determined to reel in such advertising. FDA released a batch of warning letters to manufacturers last year on that subject, and now HHS seeks to revise the regulation for direct-to-consumer (DTC) ads in a proposal that seems certain to strike the pharmaceutical industry as a violation of FDA’s authority to regulate commercial speech.

This latest set of developments regarding commercial speech dates back to a September 2025 FDA press release about DTC drug ads. FDA cited a research paper which claimed that 88% of ads by “individuals or organizations” fail to adhere to the agency's guidelines for fair balance. This paper also stated that only 33% of “pharmaceutical social media posts” mention potential harms.

The press release includes a link to the boilerplate the agency used in a series of warning letters to drugmakers, which cites a significant drop in the number of warning letters issued annually for promotional violations. The agency claims that it had previously sent “more than a hundred warning letters each year,” a time during which “misleading ads were rare.” The tally for 2023 fell to one warning letter and then to zero in 2024.

There is evidence, however, of a deliberate shift on the part of FDA’s Office of Prescription Drug Promotion (OPDP) toward untitled letters in lieu of warning letters. One analysis concluded that roughly 77% of the letters OPDP issued in 2010 were untitled letters (40 untitled and 12 warning letters). The ratio fluctuated significantly in the intervening years, but all OPDP letters were untitled letters in both 2014 (nine letters) and 2024 (five letters). It may be fair to note that OPDP issued only 14 total warning and untitled letters between 2022 and 2024 inclusive, only two of were warning letters.

The response from HHS is a pending bit of rulemaking that would require manufacturers to disclose “all relevant risk and safety information” in the ad itself. If finalized, the manufacturer would not be allowed to post ads on television or radio that redirect the viewer/listener to another source. In current advertising practice, these other sources provide a summary of the risks and benefits of the product per the FDA-approved label.

‘Overspending’ at the root of HHS’s concerns

HHS is making the case that an FDA guidance from 1999 created “a loophole that resulted in certain important information being hidden behind 1-800 numbers, print inserts and websites.” This, HHS alleges, has led to “misalignment of therapeutic choices with actual patient needs.” The purported downstream effect is a “misallocation of government resources and government overspending.” The department’s solution is to excise a paragraph from Part 202 of Title 21 of the Code of Federal Regulations.

The paragraph in question states that an ad must: “Contain a brief summary of all necessary information related to side effects and contraindications, unless adequate provision is made for dissemination of the approved or permitted product labeling in connection with the broadcast presentation.” The question now is whether the removal of this adequate provision passage from Part 202 renders 30-second pharmaceutical ads a practical impossibility.

FDA’s forays into the world of regulated commercial speech first emerged in the 20th Century and yielded the landmark case of WLF. v Henney, which the U.S. Court of Appeals for the District of Columbia ruled on in 1999. Litigated by the Washington Legal Foundation (WLF), Henney dealt with manufacturer communications regarding off-label use of prescription drug products, but the federal government has experienced several other setbacks on the question of off-label commercial speech.

Notably, U.S. v. Caronia, another off-label case, arose from the U.S. Court of Appeals for the Second Circuit in 2012. The Second Circuit ruled in Caronia that FDA cannot prosecute drugmakers or their sales reps for promoting off-label use of drug products. In the intervening years, FDA has availed itself of several opportunities to revise the intended use rule with an eye toward curbing what the agency sees as illicit communication of off-label use, one iteration of which was seen as a violation of the Administrative Procedures Act. The scope of this latest HHS rulemaking proposal is on-label rather than off-label use, although there are those who believe the underlying questions about commercial speech and the First Amendment apply here as well.

I interviewed WLF senior litigation counsel Zachary Morgan about this HHS rulemaking, something Morgan discussed in a Sept. 16 blog at the WLF website. Morgan said the practical differences between warning and untitled letters are far from mountainously significant. “I don’t think there’s a substantive difference in what FDA is trying to do” with warning and untitled letters, he said.

Pointing to the flurry of warning letters from 2025, Morgan added, “it’s clearly designed to put the regulated community on notice that they’re turning to a more serious enforcement posture.” This shift in the agency’s view of this kind of question is almost inevitably followed by a chilling effect on communication, he stated.

First Amendment the wrong lever for HHS

Morgan said HHS might have a tough time making a case for this proposal should it come to litigation. “I think if they walked in and said you’re spending too much money on the ad, they’d run into a real buzzsaw” under the First Amendment. He observed that the courts generally don’t see the First Amendment as a legitimate government lever for regulating commercial activity – such as the impact of prescription drug advertising on federal healthcare spending – when the commercial speech is neither false nor misleading.

Morgan said HHS’s litigation strategy might lean more toward a health and safety argument premised on the notion that drug advertising leads to over-medicalization. That, too, might be a difficult sell because HHS would have to argue that deleting the adequate provision paragraph from Part 202 fulfills the requirement that the solution be properly tailored to the problem. “I don’t really think this is a bone fide health and safety interest,” he stated, in that ads that are compliant with current FDA regulations already cover all the government’s legitimate health and safety interests.

The government’s case in any litigation isn’t exactly abetted by the fact that the viewer of the ad must obtain a prescription from a medical professional. Morgan noted also that HHS is likely to encounter judicial pushback in requiring all general safety information appear in an ad as this would render advertising obsolete because paying for such an ad would no longer be “a rational business choice.”

Morgan remarked that even if the rulemaking goes through and manufacturers comply with the new terms of the regulation, there is a significant probability that 60% or more of an ad would consist of FDA-mandated content. At that point, a court might plausibly conclude “that this is no longer the private entity’s speech,” he said, adding that the majority of the ad would consist of information that is “explicitly trying to talk the person out of buying your product.”