The FDA’s Proposed Drug Ad Rule Is a Blueprint for Violating the First Amendment

A customer shops in the pharmacy department of a Target store in Brooklyn, N.Y., in 2015. (Brendan McDermid/Reuters)

Interestingly, FDA’s impending rule has attracted support from the far left.

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If the FDA’s impending rule is allowed to stand, it will likely not be limited to pharmaceutical ads.

T he Trump administration acquired some unusual allies with an impending Food and Drug Administration (FDA) rule, titled “Transparency in Direct-to-Consumer Advertising,” which would effectively ban so-called direct-to-consumer (DTC) pharmaceutical advertisements by requiring that each broadcast and digital advertisement recite a prohibitively long list of government-approved “risk, contraindication, and other safety information.” That departs from a 30-year standard which allows advertisers to direct viewers to a website, where they can review that information at their own pace.


Interestingly, FDA’s impending rule has attracted support from the far left. Public Citizen, a left-wing advocacy group which brags that it “is fighting, suing, and organizing against the Trump regime,” encouraged the FDA to go further and ban DTC prescription drug advertising outright — relying, as the FDA does, on the Food, Drug, and Cosmetic Act of 1938. Public Citizen likewise has called for stripping corporations of their constitutional rights and criminally charging energy companies with homicide over climate change. Similarly, hard-left Democrats Senator Bernie Sanders and Representative Ilhan Omar each introduced versions of the “End Prescription Drug Ads Now Act,” which would ban drug advertising on all platforms.

Perhaps the administration’s new allies are not so surprising. If the FDA’s impending rule is allowed to stand, it will likely not be limited to pharmaceutical ads. Theoretically, it could be weaponized to serve as a blueprint for a future progressive administration, already hostile to industry, to insist on similar disclaimers in advertisements for fossil fuels, firearms, internal combustion vehicles, fast food restaurants, and any other sector it finds unfavorable, and that could tenuously be associated with “health.”




This is already happening in Europe, where several cities barred ads for oil, gas, and SUVs from their transit systems. Two years ago, the U.N. Secretary General urged governments to ban fossil-fuel advertising outright, alleging that the industry deceived the public about “climate change.” This shows how quickly governments can go from regulating an industry to silencing it.

Perhaps to avoid a flurry of First Amendment lawsuits, the FDA took great pains to preemptively state that its rule “does not constitute a ban or unreasonable imposition on DTC drug advertising.” The FDA is wrong. If the coming rule is implemented, it intentionally makes drug advertisements prohibitively expensive, which, by definition, is an “unreasonable imposition.” A typical 30-second commercial would extend to at least three minutes if the ad must include the long list of government-mandated safety information. The FDA concedes that its rule would be “economically significant,” estimating costs exceeding $100 million in its first year, but it still severely underestimates the cost prohibitions.


Consider that some 30-second commercial during last year’s Super Bowl cost $8 million. Under the government’s new rules, a single Super Bowl drug ad would cost $48 million or more.

More importantly, the FDA’s looming rule is not about transparency or consumer education; instead, it is a sneaky way of intentionally making speech so burdensome that silence becomes the only economically feasible option. If regulators are permitted to keep adding mandatory disclosures onto advertisements, they will never need to ban messages outright; they can simply price it out of the market.


Ultimately, the FDA’s coming rule is likely unconstitutional. Since Virginia Pharmacy (1976), the Supreme Court has protected truthful advertising for lawful products and rejected exactly this kind of  “highly paternalistic approach,” holding that “the free flow of commercial information is indispensable.” Four years later, in Central Hudson (1980), the Court created a test: A restriction on truthful advertising for a lawful product survives only if the government’s interest is substantial, the rule directly advances that interest, and the imposed burden is no greater than necessary.

The Supreme Court also is likely to be skeptical of the FDA’s claim that its impending rule is not a ban. In Zauderer (1985), the Court held that, while the government may compel “purely factual and uncontroversial” disclosures, requirements that are “unjustified or unduly burdensome” may be unconstitutional. Justice Brennan’s concurrence warned that “several pages” of disclaimers — much like the FDA’s impending disclosure requirements — would be “so ‘unduly burdensome’ as to violate the First Amendment. . . fill[ing] far more space than the advertisement itself,” chilling protected commercial speech, and going well beyond any legitimate interest in preventing deception.


The FDA’s impending rule on pharmaceutical advertising is dangerous, and almost certainly unconstitutional. A future administration can — and probably will — abuse it to silence lawful industries without having to go to Congress. Democrats and Democratic Socialists repeatedly have asserted their desire to pack or even get rid of the Supreme Court, which would strip all corporations of any remaining speech protections. Speech restrictions imposed by unelected bureaucrats are exactly what the First Amendment exists to prevent. The FDA should withdraw its rule before it’s used to target other lawful industries.

John Shu is a legal scholar and commentator who served in the administrations of Presidents George H. W. Bush and George W. Bush.
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