Wednesday, May 27, 2009


The End of Liver Failure, the Musical?

The FDA has sent out a first pass at new guidelines for advertising--both DTCA and to HCPs. Below are excerpts from a WSJ article today. Besides what is included below, there is further comment on ways _not_ to minimize risk information, which include even the level of "general impression."

That's bound to create controversy in a marketing environment.

What do you think? Can DTCA, intended to market and not simply inform, ever be "fair and balanced"? Would absolute risk numbers, as known, needed to be cited, as well as absolute effectiveness numbers related to placebo? Should they be?


The Food and Drug Administration issued proposed advertising guidelines for drug and medical-device makers, with suggestions on ways to present risk information to consumers and health-care professionals.

The draft guidelines, posted Tuesday on the agency's Web site, aren't binding, but they offer several ways that the industry can avoid running afoul of its rules. The FDA said the omission or minimization of risk information is the most frequent violation cited in dozens of enforcement or warning letters each year.

...As an example, the FDA pointed to music over the details about a drug's side effects. An advertisement for a cholesterol drug, for instance, could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed....
The 24-page document goes into detail about how fonts, the type of contrast and even white space in print materials can best present risk information.
The agency said it will accept comments for 90 days before issuing guidelines.


  1. DTCA are intended to market, but they’re not selling shampoo and toothpaste.

    Risk and efficacy numbers should be known, but until there are serious consequences for misleading the public, drugs ads will never be fair and balanced.

  2. Just a few question about DTC ads. What is the purpose? How many times does a person have to see an ad for a new product before they believe that they are afflicted?

    Shouldn’t all drugs that are advertised in the mass media be over the counter rather than prescription? The requirement for a prescription means that these drugs are meant to be closely controlled by a doctor’s evaluation. Advertising directly to the patient pretty much says that they would rather keep the doctor out of the loop.

    Which is it? Doctor - please confirm the drug I need for my ailment, or Doctor please confirm the ailment I need for my drug.

  3. Rodgers and HammersteinMay 30, 2009 at 6:57 PM

    Or self diagnosis, “Doctor, I saw what’s wrong with me described on TV and there is a drug that will cure it. So please give me an Rx for the med. Or maybe you have some samples?”


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