RFK Jr.'s Crackdown on Drug Advertising Would Face Legal Hurdles

Health and Human Services Secretary Robert F. Kennedy Jr. has made it no secret that he’d like to eliminate direct-to-consumer pharmaceutical advertising, claiming a ban would reduce prescription drug use and costs. but an all-out ban likely would face significant legal challenges.

The US is one of the few countries to permit DTC pharma advertising. It became the norm in the 1990s, when the Food and Drug Administration relaxed its stringent advertising regulations. The benefit of such advertising is that it increases consumer knowledge and empowers them to be more involved in their health-care decisions, which potentially improves patient outcomes.

Kennedy’s concern is that it may promote prescription drug overuse, increase health care costs, and potentially disseminate misleading information to consumers.

The First Amendment protects commercial speech, meaning there are limits on how much the government can restrict promotional communications, including the commercial speech rights of pharmaceutical companies. It’s unclear whether the Department of Health and Human Services, which oversees the FDA, was granted sufficient authority from Congress to attempt a ban.

Nevertheless, the government could pursue other strategies to deter pharmaceutical companies from engaging in DTC advertising in the future.

FDA’s Role

The FDA has regulatory authority to oversee advertising practices for prescription drugs. Under the Food, Drug, and Cosmetic Act, pharma companies are permitted to advertise prescription drugs, so long as the advertisement isn’t false or misleading, presents a fair balance of benefits and risks, and includes material facts about the drug’s advertised uses.

The target audience for the advertising also matters. The FDA grants pharma companies more regulatory leeway for promotional activities directed to health-care providers versus consumers.

The FDA reasons that health-care providers have the background, education, and experience to analyze the more complex information regarding prescription drug products and to use that information to make informed prescribing decisions.

Roadblocks

Despite the FDA’s regulatory authority, Kennedy would likely face regulatory and constitutional challenges if he pursued a total ban on DTC pharma advertising.

On the regulatory front, while Congress has granted HHS authority to regulate pharma advertising, this doesn’t necessarily grant the right to issue an outright ban absent congressional authorization. Pharma companies would likely argue a total ban exceeds HHS’s regulatory authority. (Perhaps recognizing this, a bill sponsored by Democrats in Congress would increase HHS’s authority to ban pharma advertising.)

Pharma advertising is protected commercial speech under the First Amendment, meaning restrictions—even those approved by Congress—are unconstitutional unless they serve a substantial interest, directly advance that interest, and are no more extensive than necessary.

Legal disputes over restrictive advertising regulations from HHS have predominantly centered on communications about specific off-label uses to health-care providers, not the content of advertisements directed to consumers. These cases tend to support the proposition that the government can’t restrict truthful and non-misleading speech about uses of FDA-approved drugs to health-care providers, even if those uses aren’t approved by the FDA.

Following these cases, many thought the FDA no longer would take enforcement action against companies for off-label promotion. That didn’t happen. The FDA continues to heavily regulate, including prohibiting in many circumstances, off-label promotion. Regardless, these cases could be cited against an outright ban that would encompass truthful and non-misleading advertising.

Courts have also applied a heightened scrutiny standard to restrictions on promotional communications to health-care providers. Judges have deemed restrictions “presumptively invalid” unless they’re narrowly tailored to directly advance a substantial interest, and there isn’t a less restrictive alternative that would achieve the same result. This heightened scrutiny standard could create a substantial hurdle or an outright ban.

Pharma manufacturers have a constitutional right to communicate information to health-care providers and can use this case law to support their right to communicate drug information to consumers. However, promotional communications to consumers can be curtailed to a greater extent than communications to health-care providers, because the average consumer doesn’t have a medical background and the government has a substantial interest in patient safety.

While there is no express prohibition on off-label promotion, the FDA has had success in effectively limiting off-label promotion by asserting certain practices are evidence of unauthorized misbranding. The FDA’s current guidance allows companies to share off-label information with health-care providers in some limited circumstances. The same doesn’t apply to consumers.

Any restrictions on pharma companies’ commercial speech to consumers likely would need to be narrowly tailored to serve a substantial governmental interest, which is a major hurdle to an outright ban.

Deterrents

In light of potential legal roadblocks, Kennedy and the HHS could pursue alternative, indirect strategies to deter pharma companies from engaging in DTC advertising. Deterrents could be implemented in a variety of ways, including by presidential executive order, administrative rulemaking, or congressional legislation.

For example, a bill introduced by a Republican House lawmaker proposes eliminating certain tax deductions available to pharma companies for DTC advertising costs, which are a major spend for the industry.

Other strategies could include limiting advertising windows to reduce frequency and timing of ads, requiring more prominent risk disclosures, and/or requiring pricing disclosures to consumers. Through such measures, the HHS could make DTC advertising so restricted and encumbered that it might deter or reduce its use.

How Kennedy and his HHS will approach the situation remains unclear. But any action against DTC pharma advertising will surely draw scrutiny—legal and otherwise.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law, Bloomberg Tax, and Bloomberg Government, or its owners.

Author Information

Judith O’Grady is partner at Troutman Pepper Locke and leads the firm’s FDA regulatory team.

Alan Clement is a first-chair intellectual property partner at Troutman Pepper Locke representing clients in the life sciences, pharmaceutical, and biotechnology sectors.

Andrew Zappia is partner at Troutman Pepper Locke representing technology and media companies in IP disputes and licensing, joint development, and commercial transactions.

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