From Snake Oil to Social Media: FDA Rulemaking Meets Legal Headwinds

One point of agreement I have with the MAHA movement is a disdain for those direct-to-consumer (DTC) pharmaceutical ads that plague my media feed. Although, while not as incensed as Secretary Kennedy,

“Pharmaceutical ads hooked this country on prescription drugs. We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.” – HHS Secretary Robert F. Kennedy, Jr.

I find my head nodding in agreement over the issue. 

Restoring Trust in Medical Decision-Making

As a physician, I can tell you that medical decisions should be made, between patients and their doctors, guided by evidence, and free of legislative fiat. FDA Commissioner Dr. Makary writes in JAMA that pharmaceutical marketing has outpaced regulatory oversight, undermined evidence-based prescribing, and eroded public trust. The FDA’s new approach aims to re-center medical decisions on patients and their doctors. Among his key concerns:

• Ads can fuel patient demand, potentially overriding clinical judgment and leading to more unnecessary prescriptions.
• Current rules let companies gloss over risks, burying warnings elsewhere. The FDA plans to require that benefits and risks be presented equally.
• Social media ads often masquerade as entertainment, highlighting benefits while ignoring harms—a clear violation of “fair balance” rules.

In short, the FDA won’t ban drug ads, because they can’t; but deceptive and misleading practices are no longer acceptable. Stronger oversight is coming to ensure honest risk-benefit information, protect the doctor-patient relationship, and reduce wasteful drug spending. More specifically, 

“Rulemaking to remove the 1997 'Adequate Provision' Loophole, which has enabled pharmaceutical companies to withhold vital safety information in advertisements. … Close digital loopholes by expanding regulatory oversight to encompass social media promotional activities.”

To understand how probable these actions are to be implemented, it is worth a moment to consider how we went from the Wild West of Snake Oil salesmen to today’s same offerings redressed for the occasion.

From Paternalism to Patient Power: The Story of Direct-to-Consumer Drug Ads

The foundational legal authority for protecting the safety of food, drugs, and cosmetics in the United States, the Food, Drug, and Cosmetic Act of 1938, created the FDA as the guardian of drug safety. It reflected the era’s horrible case of 100 deaths from the toxic Elixir of Sulfanilamide. [1] Congress granted the FDA control over drug labeling and the authority to require that all drugs be screened and approved for their safety. Advertising was primarily viewed as a consumer-fraud issue and was left to the Federal Trade Commission.

In 1959, Senator Estes Kefauver conducted hearings into advertising abuses and drug efficacy, but legislation remained stalled until thalidomide, unapproved by the FDA, but distributed to physicians for “investigational use,” turned a crisis into an opportunity. The paternalism of “doctor knows best” was beginning to crack. The Kefauver-Harris Amendments of 1962 required, for the first time, prescription drugs to be proven not just safe, but effective. It authorized the FDA to regulate the marketing of prescription drugs, while keeping over-the-counter drug advertising under the control of the Federal Trade Commission. The 1962 Amendments required prescription drug ads to

• Have a “brief summary,” a “true statement” describing a drug’s side effects, contraindications, warnings, and directions for use,
• Provide a “fair balance” of information about a drug’s effectiveness, safety, and risk. 

However, the audience for those ads remained doctors, and the media print, which allowed the pages necessary for this detailed prescribing information. 

By the 1980s, the decline of medical paternalism and the rise of a broader movement for patient autonomy, the seeds of today’s medical freedom, put pressure on old hierarchies. Pharmaceutical companies seized the moment, arguing that direct-to-consumer (DTC) advertising wasn’t about selling drugs, but about educating and empowering patients to make decisions alongside their physicians.

Regulators hesitated. The FDA insisted that companies follow the 1962 rules, which require them to disclose side effects, contraindications, and effectiveness in every advertisement. However, in an age of television advertising, this seemed — and frankly is —impossible. How could a 30-second spot carry the weight of a one- or two-page medical insert?

In 1997, after public hearings, the FDA announced new guidance. Pharmaceutical ads were bifurcated; one set of regulations for advertising to providers and another for direct-to-consumer advertisements. The FDA still required a “brief summary” of side effects, contraindications, and effectiveness to providers. Pharmaceutical companies, on the other hand, could

• Educate about a disease without naming a drug.
• Remind patients of a drug by name without stating its use.
• Run a product-specific ad that included both the drug and its purpose.

It is only this last type of ad that requires the “brief summary.” However, FDA guidance said a bit more, requiring, 

“a brief statement of all 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.” [emphasis added]

Through “adequate provision,” the pharmaceutical industry found a loophole to exploit. 

Companies could finally run TV and radio ads that name both the drug and the condition it treated without dumping the complete medical textbook of risks. Instead, they had to highlight the most important risks and provide easy access to the rest—via toll-free numbers, websites, or conversations with doctors and pharmacists. These rules unleashed the tsunami of commercials that are fixtures of American media. Once the floodgates opened, Congress had to revisit the rules to make consumer-facing ads clearer and more balanced.

Amendments for Television

By 2007, pharmaceutical advertising was no longer confined to the clinic, nor were patients content to accept only their doctor’s word. Congress amended the DTC regulation for the new lay audience so that “major statement [must be] presented in a clear, conspicuous, and neutral manner.”

• The language must be easily understandable to consumers, avoiding medical jargon.
• The audio must be as clear as the rest of the ad, with appropriate volume, articulation, and pacing.
• Television ads must include both audio and corresponding text that is displayed for a sufficient duration. The on-screen text must be easy to read.
• The ad must not include distracting elements that interfere with understanding the major statement. 

The paternalism of mid-century medicine had given way to an era where patients expected choice, information, and autonomy—even if that meant navigating a marketplace where health education and corporate promotion were deeply intertwined.

Serving Two Masters

From the outset, critics questioned whether pharmaceutical advertising could balance the industry’s drive for profit with the public’s need for trustworthy health information. Companies are answerable to shareholders, not patients, and the push for sales can easily conflict with the rational prescribing of medicines.

Supporters argued for patient empowerment; ads could spark conversations with physicians, reduce underdiagnosis and undertreatment, and even destigmatize conditions. Critics point to evidence that ads encouraged inappropriate prescribing, medicalized everyday problems, and created new “conditions” for the sake of marketing. The tension between patient empowerment and commercial influence soon moved from policy debates to constitutional battles over free speech.

Commercial speech and the Supremes

Congress has given the FDA enough “muscle” to police the content of prescription-drug ads; however, it could and cannot shut them down. Congress wrote the FDA a speech-editing role, not a mute button.

In 1980, the Supreme Court case Central Hudson Gas & Electric v. Public Service Commission arose when New York banned utility ads encouraging electricity use during the 1970s energy crisis, a move the company argued violated its First Amendment rights. The Court struck down the ban and established the Central Hudson test to determine whether commercial speech [2], which includes DTC pharmaceutical advertising, is protected by the First Amendment.

• Is the commercial speech unlawful or inherently misleading? This is the threshold for the other three tests. The First Amendment does not protect illegal or misleading commercial speech.
• Is the government’s interest in regulating the speech substantial? Protecting the public from dangerous or unnecessary drug use is a substantial public-health objective, one that the courts routinely recognize.
• Does the regulation directly advance that interest?
• Is the rule no more extensive than necessary? The decision by the FDA to allow through “adequate provision” linking a greater source of information, to satisfy this test.

However, two other cases show how hard the Central Hudson test can be.

In Thompson v. Western States Medical Center, the Supreme Court struck down a federal ban on advertising compounded drugs. Regulators feared that advertising would prompt patients to pressure doctors into prescribing unnecessary treatments. The Court rejected that rationale, warning that the government cannot restrict truthful speech simply to prevent people from making “bad decisions.” Instead, it suggested less restrictive alternatives, such as requiring clear warnings that compounded drugs were not FDA-approved.

In Sorrell v. IMS Health, the Court went further. Vermont had banned the sale and use of prescriber-identifiable data for pharmaceutical marketing, claiming the law would cut costs and protect public health. The Court held that the statute restricted both content and speaker. While Vermont’s aims may have been worthy, its method, silencing certain speakers, was unconstitutional. As Justice Kennedy wrote, the state cannot quash speech just because it finds it “too persuasive.”

Together, these cases underscore a central principle: when it comes to drug marketing, the Court has grown increasingly protective of pharmaceutical advertising as a form of commercial speech, even when regulators argue that such advertising may mislead patients or drive-up health costs. The rulings reflect that cultural shift from the medical paternalism of the 60s to the medical freedom of the 2020s. 

Legal Headwinds

The HHS Fact Sheet on its new initiative states that,

“The FDA is initiating a rulemaking process to eliminate the 'adequate provision' loophole … The action simply returns to the status quo policy pre-1997. It requires the presentation of factual and uncontroversial statements which are already legally required to be communicated in drug advertising; goes directly to the core government interests of protecting the public from deception and protecting public health…and does not unduly burden advertisers, by preserving their right to engage in commercial speech under the standards that existed prior to 1997.”

Of course, there will be two immediate legal objections. First, as I have indicated, case law in both Western States and Sorrell suggests that “protecting the public from deception and protecting public health” is not a sufficient government interest when it comes to pharmaceutical advertising. The second line of legal attack, paradoxically championed by other members of MAHA world, will be the Supreme Court’s decision last year to overturn case law giving rise to the Chevron doctrine. Rulemaking by the FDA, in the absence of a clear directive from Congress, is legally problematic.

A similar legal problem exists for the HHS plans to “close digital loopholes by expanding oversight to encompass all social media promotional activities…” The current law allows the FDA to oversee advertising by pharmaceutical manufacturers, regulations that parenthetically they are following fairly closely on social media. [3] That is not the case for influencers and commenters, where the overwhelming references were drug product claims and “posts mentioning only the benefits (44.8%, 216/482) were significantly more common than both risk-only posts (27.2%, 131/482) and posts that discussed both benefits and risks (28.0%, 135/482).”

As the Public Interest Research Group points out, “If there is no established financial relationship between an influencer or a telehealth firm and a drug manufacturer, then the FDA’s rules do not clearly apply. Surely, one of the parties impacted by the anticipated “expanding oversight” of social media will point to the absence of clear Congressional intent when it allowed the loophole in 1997 – a year that found America Online (AOL) and Netscape big platforms, and when you could “Ask Jeeves,” but Google was still a thesis in a dorm room at Stanford. 

Without clear Congressional guidance, the rejection of the Chevron Doctrine comes back to bite the butts of those who worked so hard for its overturn. 

Commissioner Makary has suggested that DTC advertising might require more “complete” disclosure. Still, the current law requires no disclosure at all if an indicated use for a drug is not mentioned. This paradoxically would reduce rather than enhance medical autonomy and freedom. 

Secretary Kennedy has suggested eliminating the tax deduction to manufacturers for DTC advertising, but consistent with case law, the government might have to identify an interest beyond reducing “drug expenditures or usage.” Legislation to require drug pricing on DTC ads may also be problematic. The price of a drug is factual, but given the discounts, rebates, PBM involvement, and insurance coverage, they are not “uncontroversial.”

Ultimately, the MAHA movement’s rhetorical crusade against direct-to-consumer pharmaceutical advertising may be limited in its impact by its legal arsenal. The First Amendment protections affirmed in Western States and Sorrell mean that courts are deeply skeptical of government efforts to silence or heavily constrain truthful commercial speech, even when justified by public health. Add to that the post-Chevron limits on agency authority, and the FDA’s rulemaking ambitions begin to look tenuous without explicit Congressional backing. The MAHA war on DTC ads may produce fiery headlines and stirring speeches, but absent legislative “clarity,” it risks being long on indignation and short on enforceable action. These are worthwhile, substantive changes, and they require more than an Executive Order.

[1] You can read the entire tragic story, along with other regulatory changes resulting from medical errors, here. 

[2] Commercial speech proposes a commercial transaction.

[3] In an article cited by Dr. Makary in the Journal of Medical Internet Research, manufacturer “drug product claims were present in only 1.6% of posts (12/740); of these, all posts mentioned the benefits of the drug (12/12) and only 33% (4/12) also mentioned its risks.” 

Sources: Direct-to-Consumer Advertising of Drugs AMA Journal of Ethics DOI: 10.1001/virtualmentor.2013.15.11.hlaw1-1311.

 The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads