A Few Takeaways from the FDA Risk Communication Advisory Committee Meeting

On February 26-27, the FDA Risk Advisory Committee met to review the following questions.  The offical docket slides.

I was able to participate in the meeting on Friday and present some thoughts with regard to “How Neuroscience Learning Might Help Improve Risk and Benefit Communications” (Thanks to some great work by Dr Medina and presentation support by Garr Reynolds of Presentation Zen) My talk suggested: 1) Greater use of multi-sensory communication elements beyond just words to include visuals,  2) Focus on what is most important–‘less is more’ — as humans generally have difficulty digesting too many pieces of information at once 3) humans need repetition to learn–so if its truly important– repeat, and lastly 4) patterns can aid learning so formats like the drug fact box can be very helpful.

I also enjoyed two of the morning presentations: 1) The Effectiveness of the drug facts box in communicating the benefits and side effects of prescription drugs (L Schwartz/S Woloshin Outcomes Group, VA Medial Center, White River Junction, VT.)  The drug fact box has received much attention recently and represents a vast improvement in design and communication of risks and benefits–and as you will see, made it into the advisory committee’s final recommendations…and 2) Consumer Medicines Information in Europe; learning from research, policy and practice (Dr Raynor Prof of Pharmacy Practice, Univ of Leeds, UK)

Catalina Health Resources also appealed to the committee to mandate one document of patient risk information at the pharmacy level. 

By the end of the two-day session, the advisory committee had unanimously agreed to 9 recommendations for the FDA. Please note that these recommendations were not handed out in writing so this represents my best summary of the committee’s discussion and final agreements:

  1. FDA should adopt a single standard document communicating the essential information (PPI, CMI, MG) through an appropriate consultative process from key stakeholders.
  2. The standard document should include quantitative summary of risks and benefits, along with use and precautionary information. [However, there was discussion that any use of quantitative summary must be thoroughly tested to insure it communicates what is intended].
  3. FDA should adopt the drug facts box as the standard format but engage in a process for the standardization of elaborating information supported by research.  This includes establishing a standard format for 2nd tier of elaborating information for those patients that want more…the full effects and unintended effects should be further tested and identified through a rigorous evaluation process, building on existing research and learning. There was recognition that all the information can’t be in one document. Engage more research, building on what’s the best format for communication; e.g. top ten lists? Q&A?
  4. FDA should rely on the existing review process to derive the authoritative information that the standard document requires, including pharmaceutical company submissions and expert panel summaries. It should include process for including up to date post marketing information on all drugs.
  5. FDA approved and required communications should be subject to rigorous empirical evaluation of their effectiveness (including usability but bigger).
  6. FDA should establish performance standards for the patient and caregiver effectiveness that are outcomes based.
  7. FDA should conduct a systems analysis of the dissemination process by which standard documents reach consumers at times relevant to their decision making about a product’s adoption and use.
  8. FDA should identify populations for which the standard document or dissemination system is inadequate. It should address their needs. (There were some very good discussions and videos of how different populations may need more thought with regard to dissemination and efffective communications e.g. homeless, illiterate, language barriers etc)
  9. FDA should continue to strengthen its practice of relying on the best available social and behavioral science for designing and evaluating communications, including research on textual, numerical and visual displays. It should foster research relevant to improving the effectiveness and dissemination of its standard documents. It should include analytical research for identifying information most critical to decision making, tailoring material to relevant populations.

Overall, I was personally pleased to see that the advisory committee recommend to FDA: ONE document for the consumer at pharmacy level vs the many they now receive, adopting the drug fact box format to provide consumers with simpler and more effective risk/benefit communications, exploring greater use of quantitative textual information and visual displays to improve readability and comprehension (though not without iterative research to insure that patients take away what is intended). The committee seemed to embrace the notion that ‘less is more’ when it comes to ‘effective’ communications for consumers…(can it really be true?)

So this is the essence of what I took away. Any other thoughts or recommendations?