Change is Good: FDA Considering a New Approach on Risk Info in DTC Ads

You’ve definitely seen the ads – you may even have had a hand in creating them. The direct-to-consumer (DTC) pharma commercials promoting the latest drug for medical condition A or disease B.


A smiling man or woman is enjoying life to the fullest after receiving treatment – perhaps by strolling through the park, meeting friends for dinner, or walking the dog.


Maybe you’re laughing along at the animated caricature humorously depicting a health issue. Or you could be sighing as you see visions of your own life in an ad, wondering if the drug would work wonders for you, too.


And then it happens: A voice is dubbed over the music in the background or lines of text are superimposed atop the imagery. The risks, warnings, contraindications, and OMG-can-you-believe these-side-effects.


What just happened? In a word: Regulatory.


But all that may soon be changing if the FDA decides to take a new approach to DTC marketing – and the underpinnings of revolution are already in the works. The agency issued a notice on August 18, 2017 requesting public input on a key issue that’s been frustrating to many of us in pharma marketing: How to properly, safely communicate risk information for drugs and medical devices.


If any of the submissions becomes a reality, the complicated risk-benefit disclosures will be a thing of the past. A new approach by the FDA could mean the potential for more DTC ads; more importantly, it could mean the phrase “talk to your doctor” will take on a new, critical role in pharma marketing.


The Current Landscape


The FDA mandates that DTC ads balance the risks and benefits when communicating information about a drug or medical device, whether online, print, or broadcast. All ads, promotional materials, videos, books, banner ads, etc. and ad nauseam. Pharma marketers that don’t properly present risks alongside benefits can end up in hot water. We’ve covered the FDA’s regulatory and Guidance on the issue, how you could be the recipient of a nasty letter from the agency - and how you don’t want the dreaded tsk, tsk from your legal department.


Shaking Things Up


If there’s one government agency that loves the status quo, it could be the FDA. So why is Commissioner Scott Gottlieb seeking to shake things up?


Well, for one – the FDA’s own research reveals that consumers don’t remember the risks in DTC ads that conform to regulations. The agency studied the issue, surveying 1,500 people with different medical conditions. Participants were assigned a video to watch – one of four different versions for the same drug; each version presented risks in varying levels of specificity. They were then asked to respond to several questions about the material.


Without getting crazy-detailed about the report in the journal Research in Social & Administrative Pharmacy, the findings may shock you: Shorter risk statements improve recall and recognition of a drug’s dangers. They also improved recognition of a product’s benefits.


That could be great news, pharma communications executives! Your job might just get easier as the regulations on presenting risk information are relaxed. And that could actually happen…in due course.


Potential Changes to Come


Before you celebrate, the FDA has to go through “the process.” The agency wants feedback, discussion about the feedback, acceptance of the feedback, feedback on the feedback, and so on.


By opening up the conversation to the public, the first winds of change are starting to blow. The FDA has presented a number of questions and is seeking answers. Essentially, the agency hopes to understand if there’s value – and how much value – in a new, two-pronged approach requiring DTC ads to:


  1. Limit the risk disclosures to only those that are severe, serious, or actionable; and,
  2. Include a disclosure that tells the audience that there are additional risks not mentioned in the ad.


The FDA is also hinting that it wants to renew emphasis on physician-patient relationships and communication about drugs and medical devices. After all, the discussion you have with your doctor should be the important one. Limiting risk information and instructing consumers to talk to their healthcare provider goes further toward ensuring safe usage of a product than what a DTC ad can do.


Proposing a limit on risk disclosures in promotional materials, with a “talk to your doctor” statement, shows that the FDA is willing to shift the safety burden – as some would argue, putting it exactly back where it belongs.

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