Fact Checking Puzzling Criticisms of a "Puzzling" DTC Study Proposed by FDA

I get periodic emails from Bob Ehrlich, Chairman of DTC Perspectives, Inc., giving his opinion on various direct-to-consumer (DTC) advertising issues.

Although I often do not agree with Ehrlich on many issues, I value his perspective and often respond to him via this blog (read, for example, "Are We at the Saturation Point Viz-a-Viz Celebrity Pharma Endorsements?"). We've even had a head-to-head podcast debate (listen to "Are Drug Marketers an Endangered Species?").

In a recent email missive, Ehrlich calls FDA’s recently proposed study of deception in DTC ads (read “Another FDA Study: Can HCPs and Consumers Recognize "Deceptive" Drug Website Promotions”) “the most puzzling FDA DTC study proposed to date.”

“I have problems with this proposed study on many fronts,” says Ehrlich. He also has at least ten questions about this study:

Questions:

1. How are consumers supposed to know what is in the approved label to decide what is deceptive?
2. So FDA will have consumers play detective like those games where you see two photographs slightly altered to spot the changes?
3. Does FDA want consumers to be the vanguard of regulation and report claims they think are deceptive?
4. Is FDA going to staff a hotline to receive consumer complaints?
5. Consumers expect the claims in an ad to be vetted by FDA so what is the study goal in purposely putting in deceptive claims to see how misled is the consumer?
6. What possible help could this study provide in future promotional guidances?
7. A study that proves consumers can be deceived and might be unable to know they are being deceived proves what?
8. Is FDA trying to prove consumers who do not know what is in the approved label can be easily fooled by rogue drug companies?
9. If a drug makes deceptive efficacy claims, it is going to be more appealing to consumers. Hello, my new drug cures cancer. You interested?
10. Is this deeper understanding using mock deceptive ads going to make FDA a better regulator?

I’d like to respond to some of these questions. But first, let me do some fact checking of statements Ehrlich makes.

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