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DTC-In-Perspective by Bob Ehrlich

How Will The Kennedy FDA Impact DTC Television Creativity

February 17, 2026 0

The violation letters that started last September and continue this year might alter how brands craft DTC advertising. FDA is using a “totality of the evidence” standard to decide if an ad is in violation. That means they are now interpreting individual statements and creative elements together. While each statement might be true, FDA is deciding that when taken together, consumers are misled as to efficacy and risk.

This “totality” rationale gives FDA wide latitude to decide if commonly used DTC scenes of active patients enjoying life contribute to misleading claims. Many letters use these scenes as a reason to find greater efficacy claims than the drug really provides. I find the “totality” standard problematic. One could find almost every ad in violation by parsing each scene. There now seems to be a highly subjective degree of oversight.

While each statement might be true, FDA is deciding that when taken together, consumers are misled as to efficacy and risk.

I understand the new FDA is showing it is tougher on advertisers. We all get it. They are taking the desire to ban DTC on television and doing the next best thing by sending more letters. As an industry we have little choice but to respond with ads more likely to pass muster. It is hard to fight an agency that has been directed by Secretary Kennedy to eliminate what we do. They are trying to end adequate provision, the regulation that allows :60 ads, but that plan will face court challenges.

The good news is almost all the ads cited by OPDP can be fixed with a few copy changes and by toning down some of the happy scenes. That may be disappointing to agency creatives, but the reality is ads can still be interesting enough to get consumer attention. I am sure MLR internal groups are increasingly nervous in their review process and will make it harder to get approval. That means brands will need more time to develop ads, create alternatives, and allow for internal review resulting in changes.

I am not overly concerned with what I have seen from OPDP. Their letters are obviously frustrating and, as I said, too subjective. What was acceptable in the past will no longer be allowed. The reality is DTC is running at record spending levels, so drug makers are adapting to the new regulatory crackdown. A few campaigns that received letters needed dramatic changes, but most were just tweaked to satisfy OPDP concerns. I am hoping FDA is satisfied by being “tougher” and drops further regulatory action relating to adequate provision. The drug industry can do its part by showing it is crafting ads that meet the new requirements.

Bob Ehrlich

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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