Oprah, Morgan Freeman in Crosshairs of FDA Drug Ad Crackdown (2)

US regulators issued a flurry of letters calling out pharmaceutical companies for allegedly misleading ads, part of a promised Trump administration crackdown on the industry’s ubiquitous TV spots, and warned Eli Lilly & Co. and Novo Nordisk A/S about their blockbuster obesity drug marketing.

Most of the letters, sent to companies including AstraZeneca Plc, Bristol Myers Squibb Co. and AbbVie Inc., detail concerns with their online, broadcast and print marketing, ranging from hiring actors who appear too healthy to omitting key safety risks. Among the offending ads are BridgeBio Pharma Inc.’s commercial for its heart drug that stars Morgan Freeman and Phathom Pharmaceuticals Inc. spots featuring Saturday Night Live’s Kenan Thompson promoting the company’s treatment for heartburn.

The BridgeBio Pharma television ad for its heart drug with actor Morgan Freeman.

Source: FDA

The tranche of letters, dated Sept. 9, coincides with President Donald Trump’s memorandum calling on federal health agencies to enforce rules on drug ads and force manufacturers to disclose more side effects in their marketing. Food and Drug Administration Commissioner Marty Makary said last week the agency had sent thousands of letters warning that drugs ads are increasingly promoting drugs “with no mention of side effects at all.”

The FDA had a stricter take on Lilly and Novo’s promotional materials for their bestselling obesity shots Zepbound and Wegovy, sending letters including warnings about Oprah Winfrey’s television special that said paid consultants for the companies downplayed their drugs’ side effects.

Novo said in a statement that the TV special was not “placed, requested, sponsored or controlled” by the company. A Novo employee was involved only as an invited guest who responded to questions, the company said.

Representatives for Winfrey didn’t immediately respond to a message seeking comment.

Lilly also received letters citing videos from local news outlets in Ohio and Oklahoma that featured interviews with company representatives, alleging that they failed to disclose key safety information about Zepbound.

“These interviews were not advertisements, and Lilly had no editorial control over them,” a Lilly spokesperson said in a statement. “We remain committed to providing patients with accurate, reliable information.”

Tougher regulation could have marked effects on pharmaceutical companies and the media outlets that rely on their marketing dollars. The drug industry spent $10.8 billion on direct-to-consumer advertising in 2024, according to a report from the advertising data firm MediaRadar.

The FDA letters, which demand a written response within 15 working days, suggest the agency is taking a hard line on laws governing drug ads. While some letters take companies to task for making misleading statements, others chastise advertisers for “frequent scene changes and compelling, attention-grabbing visuals” that make it difficult for viewers to comprehend what’s being disclosed.

The result could be more staid versions of the ads that for years have served as punchlines for comedy sketches, even as they discuss some of the most serious physical and mental challenges patients face.

Cancer Marketing

Cancer, one of the most devastating diagnoses and the biggest market for medicine, is a case in point.

Bristol Myers’ Opdivo and Yervoy for lung cancer were blasted for showing people in an amusement park and making pizza, when fatigue, diarrhea and decreased appetite are frequent side effects. Novartis AG’s Pluvicto was called out for “suggesting that despite trying and failing previous prostate cancer treatments, perseverance combined with taking Pluvicto will definitively result in a successful outcome in treating prostate cancer.” A study showed the tumors shrink in only 49% of patients.

Direct-to-consumer ads have proven effective in educating patients about new and costly medicines, and have helped drive demand for breakthrough therapies. But companies competing for market share with new drugs are also in the FDA’s crosshairs.

The agency called out BridgeBio’s ad for the heart drug Attruby, which features a voiceover from Freeman as a smiling older man walks through a high school, attends his retirement party, then travels to a national park with his family. Alnylam Pharmaceuticals Inc. got a letter about a commercial for its rival drug Amvuttra that features patients traveling and participating in activities like whale-watching.

Both ads were misleading, the agency said, because they suggest that patients “can be carefree” about the heart disease that their drugs treat, “when this has not been demonstrated.”

In some cases, the FDA took issue with the way that the commercials were shot. In a letter to AbbVie, for instance, the agency said its broadcast ad for Linzess, a treatment for irritable bowel syndrome, is misleading because “the frequent scene changes and compelling and attention-grabbing visuals” made it difficult for viewers to comprehend what was being advertised.

AstraZeneca declined to comment. Alnylam said it’s reviewing the FDA letter and is “committed to providing clear, accurate, and transparent information about our products.” Other companies didn’t immediately respond to requests for comment.

(Updates with Novo comment in fifth paragraph.)

--With assistance from Robert Langreth, Gerry Smith and Madison Muller.

To contact the reporter on this story:
Damian Garde in New York at dgarde@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

Michelle Fay Cortez, Anne Cronin

© 2025 Bloomberg L.P. All rights reserved. Used with permission.