What new advertising rules may mean for pharma companies

Seasoned TV watchers are probably accustomed to the ebb and flow of pharmaceutical ads, when depictions of relief are followed by a reminder to talk to a doctor about a particular drug, which then leads into a speedy rundown of the potential side effects of said drug.

Those ads, let alone how pharma companies advertise altogether, could soon be changing. President Donald Trump on Sept. 9 signed a memorandum to the Department of Health and Human Services (HHS) and the head of the FDA that would get rid of the 1997 “adequate provision” loophole, which lets prescription drugmakers summarize safety and risk information in TV ads and direct consumers elsewhere to get additional information.

The same day, the FDA said in a statement that it would send thousands of letters to pharma companies warning them to bring their ads into compliance, and sent an estimated 100 cease-and-desist letters to companies it claimed were running “deceptive” TV drug ads. In mid-October, the FDA published 12 more letters to pharma companies targeting other advertising channels, including websites, newsletters, and social media, Medical Marketing + Media reported.

According to the Sept. 9 memorandum, the White House claims it’s aiming “to ensure transparency and accuracy in direct-to-consumer prescription drug advertising,” arguing that drug ads can be misleading and could promote taking medications over lifestyle changes.

Policy changes typically go through a formal rulemaking process, often taking between two and three years to finalize, and the move falls short of a full ban on pharmaceutical advertising that HHS Secretary Robert F. Kennedy Jr. promised during his presidential campaign. But Kennedy’s comments about pharma ads have remained steadfast: In a Sept. 9 release from HHS, he claimed “pharmaceutical ads hooked this country on prescription drugs” and said HHS “will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising.”

Direct advertising has become a crucial way that pharma brands reach consumers, and experts say drugmakers are watching potential new rules closely, especially as the proposed changes seem poised to make reaching consumers more burdensome.

Side effects may include…

Pharmaceutical companies spend billions on advertising each year, with one study from the Dartmouth Institute for Health Policy and Clinical Practice estimating that spending grew from $2.1 billion in 1997 to $9.6 billion in 2016. In the first three months of 2025 alone, drugmakers spent an estimated $729.4 million on commercials for the top 10 pharma brands, nearly 30% more than they spent a year prior, according to iSpot data reported by Fierce Pharma.

That spending can have real results. The Campaign for Sustainable Rx Pricing, a nonpartisan advocacy group, has claimed that increases in DTC advertising result in increases in both prescription drug spending and product revenue, and drug manufacturers can also write off DTC advertising expenses to reduce tax bills. 

Perhaps unsurprisingly, then, pharma company leaders are unhappy about the proposed changes.

Alex Schriver, SVP of public affairs at PhRMA, the drug industry’s top lobbying group, said in a statement that its members are “committed to responsible advertising” and that removing the adequate provision requirement would “make it harder for patients to access valuable information they need to have meaningful conversations with their doctors.”

Kyle Faget, a healthcare practice group partner at the law firm Foley & Lardner, said closing the loophole could make broadcast pharmaceutical advertising “very expensive and very difficult” because drugmakers would likely have to buy larger and costlier ad spots to fit in the required disclosures.

Most TV ads would then likely come from the biggest pharma companies, since they’d likely be the only ones able to afford to advertise, Faget said.

Michael McNamara, managing director at McKinney Health, a full-service ad agency that works for healthcare clients, also expects that pharma advertisers may have to “significantly” change their TV advertising to comply, which could lead to longer ads. If advertisers need to buy 30 more seconds of airtime to spell out more safety and side effect information, “that’s going to cut down on your spend and cut down on your creative opportunity," McNamara said.

If ads for pharmaceutical products have to spend more time reviewing side effects, that could leave less room for brand messages, which could prompt some companies to pull out of TV advertising and redirect spend into other efforts, like doctor promotion or patient advocacy.

“​​We could see companies shifting their budgets more to [healthcare professional] advertising,” Steve Boller, VP and executive director of health for ad agency Dunn&Co, said. “Anybody that advertises to [healthcare professionals] already knows that you have to be credible and factual and specific with those audiences.”

But that form of advertising could also be under the microscope: Some of the cease-and-desist letters indicate a review of “promotional communication” for certain drugs on certain healthcare provider-branded websites.

McNamara predicts that any change to disclosure requirements could prompt a shift to “unbranded advertising,” meaning that instead of advertising a specific drug brand, ads would focus on the condition the drug brand is designed to treat. For example, a pharmaceutical advertiser that would have previously produced ads for a product targeting psoriasis could instead make ads about patients with the condition, focusing on symptoms they may have and suggesting a conversation with a doctor.

“They can do that in 15 seconds or 30 seconds,” McNamara said. “There’s no safety information, no side effects, and they can still initiate a conversation with the doctor. What you have to remember in all these cases: [This is] the goal.”

Of course, without knowing more about the rules or its enforcement mechanisms, the exact effects can be hard to pinpoint. “Like everything else with this administration, you just kind of play it day by day and see where things go,” he said.

When reached for comment, an HHS spokesperson directed us to the White House. White House spokesperson Kush Desai said the Sept. 9 memorandum “instructs HHS to increase oversight of misleading advertisements in accordance with federal law so Americans are better informed about their health decision-making.”

Compounding the challenge

What’s even more unclear is how any rule change could affect telehealth companies like Ro and Hims & Hers, which have used TV advertising to promote compounded GLP-1 products amid a surge of interest and ad spend behind the drugs. Because compounded drugs are not FDA-approved, they are not currently held to the same disclosure standards as approved drugs on the market.

A 60-second Super Bowl ad from Hims & Hers that aired earlier this year was widely criticized by health experts and lawmakers, who argued the ad was misleading and failed to disclose side effects.

Whether the FDA has authority to regulate telehealth companies’ advertising practices is something that’s been debated for years, according to Faget. “Unless somebody really wants to litigate it in some way, shape, or form, it’s unlikely that you’re going to see that playing out to get a real answer,” she said.

There has been some movement to change that. In February, Senators Dick Durbin, a Democrat from Illinois, and Roger Marshall, a Republican from Kansas, introduced the Protecting Patients from Deceptive Drug Ads Act, which would require the FDA to regulate “misleading prescription drug promotions” from telehealth companies and influencers. But so far, no action has been taken on the bill.

The consequences

While the FDA has said it plans to take “aggressive enforcement” action in the wake of the memorandum, the agency didn’t specify what that may look like and didn’t respond to a request for comment by publication.

In a Sept. 9 press release announcing the policy change, the FDA said it plans to send hundreds of enforcement letters to pharmaceutical companies if necessary, but doesn’t detail any further action. In the meantime, pharma companies and advertisers are in a holding pattern as they await further information.

But pharma companies typically come into compliance quickly when receiving an enforcement letter because they rely on the FDA to approve their products, Faget added.

“There are very few manufacturers out there that want to make an enemy of the FDA,” she said.