2025 forecast: The government crackdown on pharmas' direct-to-consumer outreach marches on

The ways in which pharmaceutical companies market their drugs directly to consumers in the U.S. could face quite the evolution in 2025—at least, if legislators and other government powers have anything to say about it.

Perhaps the most pressing threat to DTC drug advertising comes in the form of President-elect Donald Trump’s pick for the head of the U.S. Department of Health and Human Services (HHS): Robert F. Kennedy Jr. Kennedy, who has questioned vaccine policy over the years, proposed his own policy ideas throughout his own 2024 presidential run and following his HHS secretary selection that include, among others, a relaxation of childhood vaccine requirements and the reversal of drinking water fluoridation efforts, as well as an end to direct-to-consumer (DTC) pharma marketing.

In a Wall Street Journal op-ed published in September, shortly after he’d ended his presidential campaign and endorsed Trump, Kennedy offered some ideas to reform health policy. Among them was a suggestion to “review direct-to-consumer pharmaceutical ad guidelines,” about which he added, “News channels are filled with drug commercials, and reasonable viewers may question whether their dependence on these ads influences their coverage of health issues.”

He’s often been more direct: In early November, he shared a video of his speech from a Trump rally, writing on X (formerly Twitter), “Let’s get President Trump back in the White House and me to D.C. so we can ban pharmaceutical advertising.”

A recent report from research firm Intron Health posited that such a ban represents “the biggest imminent threat from RFK and the new Trump administration” to the pharma industry, since return on investment for DTC drug ads can reach “as high as 100%-500%, depending on the drug,” the analysts wrote.

A total ban on consumer-facing ads would likely face too many legal challenges to ever be enacted; time and again, in cases dating back to the 1970s, U.S. courts have ruled that advertising is protected under the First Amendment’s guarantee of the right to free speech.

That said, there are plenty of other ways that RFK Jr., the Trump administration and other government officials may seek to limit pharmas’ DTC outreach.

For example, if confirmed to lead the HHS, which includes the FDA, Kennedy could head up an overhaul of the agency’s regulations around drug ads. Those regulations received a (long-awaited) revamp just this year, as a rule took final effect in November requiring that the “major statement” detailing a drug’s side effects and contraindications be presented “in a clear, conspicuous, and neutral manner” in all TV and radio ads.

And legislators have recently called for even more changes to the FDA’s oversight of DTC drug ads, potentially empowering RFK Jr.’s agenda.

In early 2024, Sens. Richard Durbin, D-Ill., and Mike Braun, R-Ind., sent a letter to the FDA asking for an update to its guidance on how social media is used for pharmaceutical advertising, citing in particular the proliferation of social media use among children and the ways in which telehealth companies and influencers may be able to sidestep current rules on pharma marketing.

A few months later, the pair upped that request in the creation of the proposed Protecting Patients from Deceptive Drug Ads Online Act, which would formalize the FDA’s oversight of advertising on social media platforms, require that drugmakers report all payments to social media stars and give the agency the power to send warning letters to influencers and telehealth providers that don’t comply with online advertising rules. The bill was introduced to the Senate in September, after which it was referred to the body’s committee on health, education, labor and pensions.

Elsewhere, on the topic of social media, a possible ban on the TikTok social media app in the U.S. appears poised to take effect in early 2025. Though the ban wasn’t introduced to Congress with the specific aim of limiting pharmas’ online advertising work, that would certainly be a byproduct, as companies would lose an entire revenue and engagement stream from their social media outreach.

TikTok hasn’t been hugely important to most pharmas’ online strategies, but, in an interview with Fierce Pharma Marketing earlier this year about the potential ramifications of a ban, Charlotte Turner, vice president of social strategy at Ogilvy Health, pointed out that many have seen “great success” in tapping influencers to create sponsored content and in using the app as a tool for community research.


Ongoing DTC dramas
 

Those aren’t the only ways in which drugmakers could see government mandates limiting their DTC efforts.

For years, a bevy of legislators has attempted to stop pharmas from deducting their DTC ad spending from profit calculations, therefore reducing their income tax bills and, according to those lawmakers, enabling them to drive up drug prices. Those opposing the practice—which they characterize as a “loophole” in tax laws—want instead for the billions of dollars spent on drug ads every year to be included in companies’ taxable income, with an ultimate goal of reducing drug prices.

Congressional efforts to close that loophole date back at least to 2009, with the latest arriving this past summer, as bills were introduced in both the Senate and the House of Representatives to that effect with support from a host of Democratic and independent legislators.

“Big Pharma should not receive tax breaks that allow them to raise prices on life-saving medications for consumers and families. It’s well past time for Congress to step in to end these tax breaks and lower costs for everyday Americans,” Sen. Jeanne Shaheen, D-N.H., said in a statement after introducing the No Tax Breaks for Drug Ads Act in the Senate in July.

Even more recently, a group of senators banded together in the fall to take a closer look at newly launched DTC telehealth platforms from Eli Lilly and Pfizer. LillyDirect and PfizerForAll, which debuted in January and August, respectively, are digital platforms where patients can make virtual or in-person doctor appointments and order medications, tests and other health products for home delivery.

The four Democratic and independent senators sent near-identical letters to both Lilly and Pfizer in October asking for more information about their respective platforms. They focused specifically on questions of whether the doctors who are employed by telehealth providers under contract with each pharma’s DTC platform may feel pressure—inadvertent or otherwise—to prescribe that pharma’s products, potentially violating federal anti-kickback laws.

For example, as they wrote in the letter to Pfizer, “Unsurprisingly, a patient coming straight from Pfizer’s website to a telehealth appointment with a prescriber chosen by Pfizer is overwhelmingly more likely to ask for Pfizer’s medication. Further, that prescriber may have an incentive to prescribe such medication, whether or not it is medically necessary or clinically appropriate. Payments by Pfizer hold the potential to induce specific actions of the prescribing pen.”

Overall, as the senators wrote in both letters, “This manufacturer-sponsored arrangement appears intended to steer patients toward particular medications and creates the potential for inappropriate prescribing that can increase spending for federal health care programs.”

The lawmakers requested answers to their lists of questions by the end of November; both companies reportedly stressed the contracted doctors’ independence in their replies.

Though only time will tell whether any of these proposed limitations on drugmakers’ DTC outreach ever take effect, there’s no doubt that those and other attempts at a crackdown will continue to crop up and pursue the pharma industry through 2025 and beyond as new leaders take office, social media use skyrockets and drugmakers see their profits boom from DTC efforts.