FDA Adds Patient Engagement Advisory Committee

Posted on September 21, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Today on the FDA blog they announced the first ever Patient Engagement Advisory Committee. I’m sure that patient advocates all over the US are celebrating this addition. I love this acknowledgement on the blog post announcement:

Although it may seem odd in retrospect, the development of new technologies intended to improve patients’ lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important.

But that’s changing.

This is a great first step for the FDA to have more involvement from the patient. It can be easy as a researcher to ignore the patient voice when looking at the data for a drug or medical device. Hopefully this new committee will provide a more well rounded view of the impact their choices have on the lives of patients.

Here’s the outline of ways the FDA thinks this patient committee can help the FDA:

  • to help identify the most important benefits and risks of a technology from a patient’s perspective;
  • to assess the relative importance to patients of different attributes of benefit and risk, and clarify how patients think about the tradeoffs of these benefits and risks for a given technology; and
  • to help understand how patient preferences vary across a population.

I’m excited to see how this works out for the FDA. Although, is it just me or does one patient committee feel like a bad strategy for engaging patients? How can one patient committee understand the impact of hundreds of drugs and medical devices. It almost seems like every drug or medical device needs its own patient committee to be able to provide quality feedback for that drug or medical device. Maybe you could narrow it a bit more to specific disease types or something.

I realize there’s a massive scaling problem when you start talking about one patient committee for every drug or medical device. I’d suggest that the company submitting the drug or medical device could provide the patient committee, but that would be fraught with conflict of interest. Even if the FDA opened up a virtually committee online you can imagine how the various companies would game that system by “encouraging” patients to submit comments to that virtual online committee.

Maybe the best solution would be to work with the healthcare organizations themselves and get them to encourage patient feedback on the various drugs and medical devices that are being approved. I’m sure there are ways that can be gamed as well. The key for me is making sure that a broader patient voice is heard. One committee is a great step forward, but that’s putting a lot of power into a few people’s hands and they may not have the time or understanding needed to provide quality feedback across the wide variety of drugs and medical devices that are being approved by the FDA.