FDA DTC guidelines are dated

  • Fair balance in TV commercials is largely ignored.
  • Today, people go online for health information and go to pharma product websites BEFORE requesting an Rx.
  • The “safety page” on pharma websites is still one of the top page views of the website visitors, but they find the content to hard to understand and confusing.
  • Online health seekers are turning to social media more and more to share their experiences with prescription drugs.

We have been testing a new DTC spot with our target audience and found that in all cases, they largely ignored the fair balance even it was read slowly with non-distracting visual content.   When we probed deeper people said that they would go online to learn about potential side effects and that in all cases side effects were more important than cost (all had health insurance).

The FDA, in its wisdom, requires that drug companies include fair balance in TV spots and on the first page of product websites, but that thinking is dated and doesn’t reflect today’s online health seekers.

In all of our research, we found that when people are interested in a new drug they go online to learn more, but they are distracted by the fair balance copy at the bottom of product websites .  “The warning at the bottom of the page are blasted in your face” said one person in the research groups (n=34). “If I’m interested I’ll read about the drug side effects and then go to Facebook or Twitter to see what other people say”.

We reviewed some safety pages on popular drugs and asked our research participants to design their own safety page.  They consistently came up with:

  • Bullet points in common English.
  • The likelihood of getting a specific side effect.
  • Percentage of reported side effects in clinical trials.

This research is consistent with what we have heard over the past 3-4 years and is a clear indication that the FDA still is clueless about how patients make a decision to ask for a certain treatment (product).

The FDA would be best served by inviting Manhattan Research in every year to talk about their research on how people are making treatment decisions.   Fair balance on TV is a waste of money.  It’s time the FDA acknowledged that.

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