FDA vs. Drug Ads: Cut the Kids and Dogs, Spell Out Side Effects

2/6/12Follow @arleneweintraub

If you’ve turned on your TV anytime in the last, oh, decade or so, you’ve no doubt been bombarded by ads imploring you to “ask your doctor” about Drug X. And you’re well familiar with the routine: You get treated to happy images of folks dancing, perhaps, or walking their dogs in pretty green meadows, while a soothing voice in the background tells you that Drug X may cause you to lose your ability to drive safely, lose your vision, or lose your mind.

Forgive the exaggeration but you get the picture.

Well, the FDA isn’t pleased with the pharmaceutical industry’s advertising practices. So it’s proposing a new set of rules that would not only limit the ability of drug advertisers to use so many cheerful images, but may indeed force them to place more emphasis on their products’ potential side effects.

The FDA actually proposed the new rules back in 2010. But it re-opened the matter to public comment on January 27, after it published the results from an experiment it sponsored to measure the impact of distraction on consumers’ ability to understand the risks and benefits of drugs being advertised. The rules would pertain to direct-to-consumer (DTC) ads for prescription drugs on television or radio.

The original proposal is rather bulky. But here are the basics of what the FDA is suggesting: The agency wants to amend the rules for DTC advertising to more clearly define the standards for determining whether side effects are presented in a “clear, conspicuous, and neutral manner.” For example, the new guidelines would dictate that the adds cannot include “distracting representations,” such as statements, images, or sounds that might draw the audience’s attention away from those laundry lists of potentially adverse events.

So what exactly makes an ad distracting? The FDA’s proposal doesn’t really spell it out clearly, but you can get a hint of what the agency was thinking in the newly released report on its study, which it titled, “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements.” The FDA planned the study to answer a number of questions. Among them: Do visual images that are positive in tone affect viewers’ ability to comprehend the risks inherent in a product? Do positive images influence how people feel about the product? And if the advertiser super-imposes text onto the images—spelling out the side effects—does that change how viewers perceive the product?

All good questions, to be sure. To answer them, the FDA asked 2,000 consumers to go online and watch an ad for a fake blood-pressure drug called Zintria. But the participants didn’t all see the same ad. Some heard the side effects cited while watching “mildly” positive images (rocks, chairs, metal arches), while others saw “strongly” positive images (babies, puppies, girls jumping with beach balls). Some viewers saw the side effects spelled out in superimposed text, while others didn’t.

Not surprisingly, those who watched cute babies and puppies while hearing about the side effects felt better overall about the product than those who watched the more boring images. Both groups, however, understood Zintria’s risks just fine—and they really got it when the side effects were displayed on the screen in clear text, too.

The FDA has published the study on the Web and re-opened the proposed rules to comments, which the public can submit up until February 27 (instructions below).

We here at Xconomy are plenty distracted by the plethora of peppiness in drug advertising. Here are our votes for … Next Page »

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  • Bob

    Anybody hear of Freedom of Speech? FDA is stepping over the line but nobody will challenge them since future drug approvals are at risk. This stuff would not hold up in a Constitutional debate.

  • Nicole

    I don’t mind the happy pictures while saying this may kill you, because at the end of the day a professional doctor has to prescribe the medicine and the consumer must be made aware of the potential side effects. I DO have a problem with all of the sexual dysfunction advertisements that come on during “family” oriented television (shows and times). I do not want to explain to my 5 year old what it means to have an erection for more than four hours!!! Please include time appropriate advertising for things that are targeted towards a more mature audience!

  • Rogan

    @Bob: Commercial speech isn’t the same as political speech.

    I’m actually not sure why Direct to Consumer advertisement is legal for prescription drugs. Consumers have no idea how to choose between drugs, and the very way that they are marketed speaks volumes to this.

  • Betsy

    Right, Rogan — we’re asking the wrong questions. Why do we as consumers allow the pharmaceuticals to advertise at all, as well as make huge profits, instead of reducing the cost of medications?

  • Dreama

    Betsy and Rogan: I completely agree with both of you. My mother (a nurse) and I had this discussion a few years back. Because we, as the actual consumer of the medication, do not know the harmful side effects that could be caused to yourself and they don’t mention side effects and adverse interactions with different medications, we (mom and I) thought it was completely unethical of the drug companies to be marketing their ‘products’ to the consumer.
    There are drug representatives who spend countless dollars wining and dining the staff of doctors’ offices who are trained in presenting these drugs to the doctors. This is what they should stick with in our opinion. The drug companies still make millions upon millions of dollars, but we as the consumer, are given the risks and benefits by a trained professional instead of happy puppies and ocean-side views.

  • http://www.xconomy.com/author/aweintraub/ Arlene Weintraub

    Thanks, all, for your comments. A bit of trivia: Only the U.S. and New Zealand allow direct-to-consumer drug ads on television! The practice is banned in all other countries.

  • Elina

    I think that ads have to match the message that they portray. The image of the Lunesta commercial comes to mind. The beautiful butterfly..and the peaceful sleep… No one ever mentions the HUGE side effect profile…it’s gone through very quickly at the end…Freedom of speech has nothing to do with this. As a drug company, you have to market EVERYTHING and not just focus on the positive aspects of the drug. At the end of the day, people are very influenced by advertisements, and yes, someone who is VERY sleep deprived might look at the images and say, “Wow, I can have that!” and not once think about the side effects. Yes, it’s the doctor’s responsibility to counsel patients, but seriously, how many doctors tell patients EVERYTHING there is to know about a prescription? No offense to doctors, but they see you for 5 minutes, and that’s it. Most of the counseling is done by the pharmacists. In the pharmacy, we always hear, “Well, the doctor didn’t tell me that!” or “I take this medication and my doctor didn’t warn me about taking the two together.” So, yes, commercials have to also EMPHASIZE the side effects. I’m all for the FDA doing this….

  • Judy

    Direct-to-consumer marketing of drugs is not only dangerous but also hugely expensive. Drug companies demand extremely high prices for their drugs and justify it with the cost of R&D – but when you look at their financial statements you see what is really costing the big bucks: adverting. Case in point, Pfizer’s PnL for 2010 shows approx. $9.5B in R&D (admittedly a nice chunk of money) but the real whopper are the “Selling General and Administrative” with almost $24B – that’s where advertising is – and of course, other cost associated with selling the drugs.