is all that rambling too confusing?? fda thinks so.

Are you tired of television ads for prescription drugs that warn of nausea, insomnia, diarrhea and suicidal thoughts? Well, I (KW) am and I’m not alone.   In my opinion, it’s crazy that direct-to-consumer marketing is even permitted.  We are one of only two countries that even allow direct-to-consumer advertising.  New Zealand is the other.

The FDA recently announced that they are going to study the impact of the long list of side effects on consumers.   The FDA says they’re concerned that the warning list “is often too long” and may “reduce consumer comprehension” and sensitivity to dangers.

On the one hand, I agree that the long rambling list of side effects ranging from the serious, life threatening thoughts of suicide to the annoying nausea, insomnia, and diarrhea is almost laughable and no one really takes it serious.   Just look at all the spoofs about drugs ads on Saturday Night Live.  Even Consumers Union produced this video in 2007 which contains a hilarious ode to the lengthy adverse events disclosure on TV commercials.

Direct-to-consumer advertising of prescription drugs shouldn’t be allowed, but since it is, I believe that the warnings should be strengthened, not reduced. I’d like to see warnings required  to include the number of patients reporting each of the possible complications warned of, including the total number of deaths linked to the medication.  Bottom line, the industry views these ads as advertising, not education.  The purpose is to sell drug company products.    I think back to the commercials that were airing in 2003 when Woody was still alive, and none of them listed suicide as a side effect.

One has to wonder who’s REALLY behind reducing side effect information??  Is it consumers?  Or is it Pharma along with their media lobbyist friends??  We are still waiting for the results from 2007 FDA’s study on impact of adding the Medwatch information to television commercials.  During the 2007 PDUFA negotiations, Consumer Union and others advocated for adding Medwatch information to all direct-to-consumer advertising.  It was agreed that this information would be added to the print advertising, but Pharma and the media lobbyists were opposed to it in TV commercials without studying the impact on consumers first.   Consumers may be “confused” with this information.   Sound familiar??

We will be keeping an eye on this latest development.  In the meantime, the FDA is looking for public comments on the study, and researchers will finalize the study design afterward.  We encourage everyone to submit comments to the Federal Register and flood them with requests to ban direct to consumer marketing or at least strengthen the warnings, not reduce the warnings.  The deadline for public comments is April 21, 2014.