Pharmaceutical advertising is everywhere. Supporters say that these ads exist for a reason: to educate and empower patients about new treatments and to provide a forum for them to engage in conversations with their doctors.
However, Secretary of Health and Human Services Robert F. Kennedy Jr. has a different view and recently announced that HHS was taking steps that could limit, or effectively ban, pharmaceutical advertising.
Kennedy believes the industry is using a “loophole” in the law to run its ads on television. He is proposing to “shut down” the ads through a mountain of red tape and disclosure requirements.
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Before 1997, the Food and Drug Administration’s bewildering disclosure requirements made advertising essentially impossible. The television and radio ads could not include all the disclosures required by FDA regulations, amounting to a de facto ban on such communications. Then, in 1995, a court first held that the administration’s regulations were violating the First Amendment (a case in which I was involved). Two years later, GlaxoSmithKline, a company I was later to become General Counsel of, threatened the FDA with a First Amendment suit unless it modified its approach to allow direct-to-consumer media ads.
Recognizing that its ban was constitutionally indefensible, the FDA made this change, allowing advertisers to meet its “fair balance” requirement by including a “major statement” of major risks and then directing consumers to where they could find the full product information. That compromise was successful: consumers were notified, the courts were happy, and communication took flight.
Oddly, now the FDA labels the “adequate provision” a “loophole.” It was and is no such thing. It is a necessary accommodation to allow consumers to receive truthful, non-misleading, scientifically substantiated information about medical products that could save their lives. If FDA or HHS were to seek to re-impose a de facto ban on DTC advertising, the courts would strike such a ban down in an instant.
The FDA’s proposal raises difficult constitutional questions, and some practical ones: Are consumers better off with less information? When patients are deprived of knowledge about new or emerging treatments, the result isn’t safety; it’s silence — and that silence can potentially kill. The proposed reforms may sound technical, but they would be transformative in effect.
By adding so many new disclosure and disclaimer requirements to every 30 seconds of an ad, HHS and the FDA would again render compliance nearly impossible. A commercial with so much mandated language that it can’t say what it wants to say is not “regulated speech.” It’s a gag on speech.
The Supreme Court has protected truthful commercial speech in years past. In Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council (1976), the court struck down a ban on drug-price advertising, noting that consumers needed to know the details of lawful products to make ethical decisions. In Thompson v. Western States Medical Center (2002), it struck down FDA regulations effectively banning pharmacy ads, noting that the government “may not seek to remove a perceived harm by silencing truthful speech.” And in Sorrell v. IMS Health (2011), the high court reiterated that the government may not restrict speech simply because it affects behavior. The Kennedy proposal violates these core principles.
If a rule renders communication impossible, it will simply act as a ban, and a ban under the First Amendment is presumptively unconstitutional. Pharmaceutical companies are commercial speakers, but the First Amendment protects that speech, too. In Citizens United v. Federal Election Commission (2010), the Supreme Court ruled that the First Amendment does not allow speech restrictions based on a speaker’s corporate identity.
A truthful drug advertisement, which identifies benefits, states possible risks, and directs viewers where to go for more information, is not just marketing. It is part of a broad public debate about health, innovation, and people’s individual empowerment. Stifling that speech because it might encourage patients to ask questions is viewpoint discrimination dressed up as consumer protection.
It would reverse a settled balance between safety and free speech — and open a challenge under both the Administrative Procedure Act and the First Amendment.
Proponents of the restrictions say that advertising misleads patients or puts pressure on doctors. But the solution to misinformation is more information, not silence. DTC ads have driven millions to seek care for conditions they might otherwise refuse. Often, these can lead to earlier diagnoses, better adherence, and more favorable outcomes. When the government quashes communication, it is not eliminating risk; it is eliminating knowledge.
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Regulators already have the authority to penalize false or misleading advertising. What they cannot do is enact rules so heavy that legitimate ads cannot run.
HHS should abandon this misguided effort to control speech and reaffirm the balance from 1997. Censorship is never the answer to misleading information in a democracy. Transparency — and trust in the public’s right to know is the cure.
Daniel Troy is a former chief counsel of the Food and Drug Administration.
