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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

DTC in Perspective: FDA Seeks Input on Risk Disclosure. More Study or Action?

September 1, 2017 0

The FDA is starting the process of possibly reducing the required number of risks presented in television ads. They have opened a docket to solicit public input on 8 questions they raised. I expect this process to be lengthy as speed has never been a guiding principle of the FDA’s Office of Prescription Drug Promotion (OPDP). They are taking their usual approach of being extremely cautious in making changes to their risk disclosure guidance.

Bob Ehrlich
“OPDP already has enough data.. to issue a revised guidance…”
-Bob Ehrlich

This is not the only area of a slow pace in recognizing the changes in consumer communication. They have, for years now, failed to recognize the role of DTC in social media and delayed any useful guidance that recognizes how consumers actually use the Internet. Thus, it is still prohibited to actually use a drug name and indication without the fair balance, as if consumers do not know how to click through to get more information.

Their own recently published research showed that less risk presentation is better for consumer comprehension and retention. For them that finding is the start of a rigorous research process to see if their hypothesis that “less is more” in risk presentation should be implemented in terms of changing their guidance.

Some conclusions are obvious and action is sometimes better than continued study. While I know OPDP is deliberate in making any changes to guidances, we have had broadcast ads for 20 years already. That is slow even by government standards. It is painfully apparent that DTC ads are presenting way too many risks and that litany approach is ridiculed by satirists and critics. Consumers complain about the many risks presented and have been for years. What does FDA do about it? They seem to want more and more studies so they can come out with a “perfect” guidance. This attitude is hurting consumers. A whole generation will have watched DTC ads with too much confusing risk information before FDA finally acts. OPDP already has enough data and should have the people with the judgement skills to be able to issue a revised guidance today.

Studying how risks are presented in DTC ads made sense in 1997 in the introductory DTC broadcast period. For them to just begin to study reducing the number of risk disclosures after 20 years is both puzzling and concerning. OPDP frequently says as a reason for slow progress on studies is that they have constrained human and budgetary resources. Yet they have managed to conduct several studies on things that many in the drug industry find tangential and not actionable. They should have focused more on this area as comprehensible risk presentation is critical information for consumers. They must develop a better strategic focus on what are their priorities for DTC research. If you look at their research web page, you see a lot of projects that seem to be all over the map that may satisfy the curiosity of their researchers but has no actionable benefit to consumers.

I am sure they will get a mountain of feedback from their docket request and they will meticulously wade through that to use as a basis for new studies. I personally know some of the researchers at OPDP and they are top notch professionals. Maybe they are as frustrated as I am. They must be caught in the bureaucratic ways of government, however, to be taking so long to resolve the risk disclosure issue. Maybe it is time for OPDP to move things along or get new leadership. No one in the private sector would still have a job after taking 20 years to resolve such a fundamental issue. Sadly, OPDP is allowed to operate in a different universe of accountability.

Bob Ehrlich