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DTC-In-Perspective by Bob Ehrlich

FDA 9/9 Letters Update: What Changed in DTC Advertising

December 11, 2025 0

The FDA 9/9 letters reshaped DTC advertising. Three months later the real impact is emerging, from ad pauses to pushback on net impression claims. On September 9 the FDA issued 27 untitled letters to pharma companies over allegedly misleading television ads. We reviewed what has actually happened to the DTC efforts of those cited brands.

Nine brands have gone completely dark on television. Eleven are still running what appear to be the same ads, which likely means they are disputing FDA’s interpretation or are negotiating modifications. Four brands have revised the cited ads and returned to air. Three have introduced entirely new creative.

Only four matters have been formally closed, indicating FDA has accepted the company response. The fact that eleven cited ads are still on air suggests drug makers believe they remain in compliance and are prepared to defend their position.

FDA’s rationale for citations varies, but the most common is overstated efficacy. Sometimes FDA points to clinical data they believe contradicts the claim. Other times they argue the “net impression” overstates benefit, even when the supers are clinically accurate. In those cases, FDA says the emotional tone—patients looking “too happy,” “too energized,” or “too cured”—creates an impression inconsistent with the drug’s actual performance.

Another recurring issue is distraction during fair balance: rapid scene cuts, visually stimulating footage, heavy music, or supers that are difficult to read. These are adjustments drug makers can fix relatively easily. Consumers are not harmed by a more subdued fair balance section; in fact, boring is often better.

A tougher FDA means advertisers must be more cautious, not that they should abandon television.

What troubles me most is the widening use of the net impression standard. It gives FDA enormous latitude to declare a violation based on the subjective view of a single reviewer. Several letters cite nothing more than “smiling patients” as evidence of overstated efficacy. That is an arbitrary benchmark and I expect companies will push back hard.

The good news: after the 9/9 blitz, FDA appears to have cooled down. They made their point, and the entire DTC ecosystem is now paying attention. The bigger question is what comes next—specifically, whether FDA intends to eliminate the “adequate provision” pathway that has enabled broadcast advertising for nearly three decades. Any attempt to restrict it will ultimately be a First Amendment fight, and courts have historically required a very high bar to curtail commercial speech. With 28 years of DTC television and no demonstrated public health harm, FDA would need overwhelming evidence to justify new limits.

I remain confident that DTC television will endure. A tougher FDA simply means advertisers must be more cautious in claims and more disciplined in fair balance. The industry will adapt. And we should not let FDA bluster scare us off the broadest reach channel we have.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Super Ads?

February 14, 2025 0

Pharmaceuticals joined the big advertising game in New Orleans, running two :60 spots. They were not ads for a particular brand but were corporate type messaging. Novartis focused on breast cancer in what was a unique creative montage of showing breasts in a myriad of situations both real life and in art. This ad was certainly 180 degrees different from what would be expected in a drug company breast cancer awareness ad. For about 40 of the 60 seconds the theme was just look at the breasts with a musical background saying “I know you are looking.” Actress Hailee Steinfeld was part of the montage.

Then, in the last 20 seconds, a more conventional looking appeal started for diagnosing breast cancer with comedian Wanda Sykes. She encouraged patients to get early detection and treatment. Clearly Novartis wanted to break the mold of the standard disease education ads. They did.

You can’t be boring, and Novartis and Pfizer certainly met that requirement.

Pfizer was also up to the creative task with its highly engaging cancer research ad. Showing a child in a hospital bed who then gets up and parades through the streets in a Rocky-like scene with boxing attire. A super appears saying to cancer that we are going to knock you out. Singer LL Cool J provides the background song. Then the ad closes with a super saying Pfizer is working on drugs for eight different cancer breakthroughs by 2030.

Both ads are excellent in getting the stopping power needed for a Super Bowl entry. You can’t be boring, and Novartis and Pfizer certainly met that requirement. Each ad left you guessing what the ad was for until its last third. This is in keeping with Super Bowl ads in general trying to hook you on a story before revealing the sponsoring brand or company.

Branded drug ads are just not going to work on the Super Bowl. Spending millions on an ad with half devoted to risks and side effects does not make sense. That brings us to a third drug ad, but not from a drug company. Hims & Hers, a direct seller in many drug categories, ran a provocative ad critical of the cost of drugs and saying the health care system is not working for us. The first part of the ad was on obesity disease education; fairly standard stuff. Then the ad tore into the weight loss industry for failed approaches and pharma for high prices. Then it turned to how Hims & Hers has affordable meds made in the USA.

Congress is concerned that companies like Hims & Hers are advertising drugs with no fair balance. Proposed legislation would treat these drug sellers similarly to pharmaceutical companies. After all, they are making drugs through compounding and are trying to diagnose and sell directly. Sounds like a drug maker. Why are they able to compete with drug companies but allowed to eschew fair balance? These compounded drugs carry risks and side effects similar to Wegovy or Zepbound. Hopefully Congress will impose reasonable requirements to add fair balance as these types of direct sellers are booming. The Hims & Hers ad was attention getting and tapped into the concerns consumers have about GLP prices. That said, it is ironic the only Super Bowl drug ad was not from a drug company.

 

Bob Ehrlich