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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

The Tidal Wave of Violation Letters: FDA Turns Up the Heat on DTC Advertisers

September 19, 2025 0

When Robert F. Kennedy Jr. was nominated, I wrote that FDA could slow direct-to-consumer (DTC) advertising simply by finding more ads violative. Reviews are subjective: an ad can be flagged for over-promising efficacy or for distracting visuals during fair-balance disclosures. It now appears OPDP reviewers have been told to be tougher—and the flood of letters proves their intent.

The FDA just released a raft of untitled letters on television DTC ads, citing about 25 branded spots. Normally I’d discuss each case, but given the volume and similarity, it’s more useful to focus on the recurring themes.

OPDP now concludes many ads are misleading because they overstate a drug’s effectiveness—not through a specific false claim, but through the overall impression. Too often, ads show patients transformed into active, happy, contented people, while real-world benefits are more nuanced.

“OPDP is now prosecutor, jury and judge. That is our new regulatory reality.”

Other frequent violations involve fair balance: distracting visuals, rapid scene changes, or supers that are hard to read. Many of the ads now criticized were pre-cleared before airing. What passed once is suddenly unacceptable.

These new violations are a royal pain for marketers, but most are fixable without lengthening commercials. OPDP essentially wants ads to tone down net efficacy impressions and run very plain, even boring, fair-balance segments. This looks like the opening shot in a sustained OPDP campaign to discourage TV use by making ads harder and costlier to produce.

It feels unfair to penalize ads that regulators previously approved. Yet HHS signals a new sheriff in town: Kennedy and his deputies intend to “gun for the bad guys.” Drugmakers will have to rethink the creative vehicles that make commercials engaging. “Fun on the beach” may give way to “fun in the nursing home.”

Expect many more letters. Most DTC advertisers should assume one is coming. And because OPDP now acts as prosecutor, jury, and judge, it will be hard to rebut such subjective assessments. That is our new regulatory reality.

 

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DTC-In-Perspective by Bob Ehrlich

Congress Acts on Telemedicine Drug Advertising Regulation

March 4, 2025 0

The unbalanced playing field between pharmaceutical manufacturers and telemedicine sites selling versions of approved drugs is finally being addressed in Congress. Congress acts on telemedicine drug advertising as senators push for FDA oversight. A number of large telemedicine direct sell sites have emerged in recent years. These sites diagnose, prescribe, and ship versions of popular drugs. When they advertise, they are not currently held to the same regulation as pharmaceutical companies.

Sites like Hims & Hers advertise compounded drugs or the forms of drugs without fair balance requirements. Frequently prescribed categories are weight loss, antidepressants, insomnia, and erectile dysfunction. They are not currently regulated by FDA even though they are manufacturing drugs and advertising them.

Senators Durbin (D-IL) and Marshall (R-KS) are co-sponsoring a bill to require FDA regulation of advertising from these telemedicine sellers.  Pharmaceutical companies have been at a competitive disadvantage because these sites often use compounded versions or created combinations of drugs. Drug companies lose sales because these telemedicine drugs often are priced lower.

Telemedicine sites have made diagnosis, prescription, and fulfillment easy for consumers. The problem is they can make efficacy claims without risk and warning information. Drug makers are held to a much higher standard and therefore have an unfair competitive landscape. These direct sale companies are offering a great perceived benefit for consumers. Answer a few medical questions, get prescribed, and receive the drug by mail. I imagine few consumers are turned down from getting prescriptions under the telemedicine process.

Telemedicine sites have made diagnosis, prescription, and fulfillment easy—but without the same regulatory standards as pharmaceutical companies, is it fair competition?

Congress is worried about inappropriate prescribing and the overpromise of efficacy without fair balance, prompting action on telemedicine drug advertising. Drug makers are concerned that compounders are violating patents and creating versions of their drugs which are not going through rigorous quality controls.

While DTC drug advertising receives lots of criticism, it is the most heavily regulated advertising category. Hopefully, that rigorous regulation will now apply to the burgeoning telemedicine industry.

Bob Ehrlich