The days of burying drug risks in fine print may be over.
On September 9, the Trump Administration issued a memorandum directing the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) to enforce prescription drug advertising rules under the Federal Food, Drug, and Cosmetic Act to “ensure transparency and accuracy” in consumer ads.
HHS responded by announcing plans to roll back its 1997 rule that allowed for “adequate provision” of risk information, signaling a return to full disclosure of risks in drug ads. The FDA quickly followed, sending over 100 cease-and-desist letters to pharmaceutical companies demanding they fix or pull ads that highlight benefits while downplaying risks. The recent warning letters make it clear that enforcement is not theoretical; it is here, and it is sweeping.
For PR and communications professionals, this shift changes the playbook. At CURA, we help clients stay ahead of regulatory changes and build impactful, compliant campaigns across all channels of paid, earned, shared and owned. Here are three takeaways from the new ruling you need to know to keep your campaigns aboveboard:
1. Make room for risk — claims can’t stand alone.
The FDA is closing the loophole that most companies used to shorten their ads to fit regular ad segments and maximize airtime. Instead of “adequate provision” of risk information (making a major statement of risks and driving viewers to other sources for more), prescription drug ads must now include risk information that is “reasonably comparable” to drug benefit claims.
Expect longer scripts, more creative restrictions and stricter legal review. “Bang for your buck,” 30-second segments may now mean prioritizing compliance over pure persuasion. Alternatively, we could see some longer spots detailing additional drug benefits and risks to meet balance requirements. The format for pharmaceutical ads we’ve all grown familiar with is certainly going to change.
2. Creative decisions are under the microscope, and style matters.
The FDA’s warning letters emphasize that it’s not just what you say, but how you say it. The agency explicitly called out “attention-grabbing visuals,” upbeat music and influencer-style testimonials as distracting from risk information and unacceptable under the “fair balance” requirement.
This is a major signal: fair balance is not satisfied by dumping risk text in a caption or webpage footnote if the overall effect on the consumer is to minimize the risks and maximize benefits.
PR professionals must partner with creative teams to ensure stylistic balance by incorporating clear visuals that can’t be construed as misleading, voiceover pacing that matches benefit claims, and design layouts that don’t bury the risk language.
In the near term you can expect legal to be more involved in review, even early on in creative conversations, as everyone familiarizes themselves with the new rules.
But AI isn’t just sourcing from your owned content; investing in your earned media strategy is essential to establishing the credibility and authority that generative AI cites.
3. Every channel is in play, not just TV
PR professionals should understand that the FDA’s anticipated rulemaking applies not only to traditional ads, but wherever a consumer encounters prescription drug promotion. This includes company website product pages, sponsored search links, paid search promotional messages, TV segments, promotional materials and editorial-style interviews posted online, to name just a few.
The September warning letters span all these formats, with some of the most high-profile examples targeting GLP-1 drugs marketed through social media, sponsored search and telehealth platforms.
Communications teams should proactively audit not only major media buys but also owned digital assets and partner promotions. Revisit your influencer contracts and agreements. A non-compliant product page or search ad can now draw the same scrutiny as a multimillion-dollar broadcast campaign.
The legal landscape is still shifting
Although the flurry of activity at the FDA has public affairs and communications specialists ready to shift tactics to comply, the new advertising landscape is far from settled.
The U.S. is one of a few countries that allows direct-to-consumer marketing of prescription drugs. That’s because the First Amendment provides strong speech protections and considers pharma ads commercial speech. Given the long history of prescription drug marketing in the U.S. and strong protections for freedom of speech, the FDA will likely face legal challenges from pharmaceutical companies.
Until the new rule is in place at the FDA, and unless the courts find that it’s unconstitutional, communications and legal teams will need to work together to monitor for changes, comply with these new rules and develop communications and marketing strategies that meet campaign goals while remaining compliant.
Bottom line: drug advertising is entering a new era of stricter oversight, and success will depend on balancing creativity with compliance.
Unsure how to navigate the changing regulatory environment?
Sarah Farinelli
Account Director