FDA should make it easier to hear patients’ voices

"The industry has hijacked that microphone." This was the alarming diagnosis given by Dr. Vinay Prasard as he discussed a paper he recently coauthored in JAMA Internal Medicine. The paper analyzed the patient testimony provided during the public comment portion of FDA Advisory Committee meetings on cancer treatments. Their analysis showed that many patients providing testimony at these meetings had some sort of financial tie—for example support for travel—to the industry sponsor presenting at the Advisory Committee meeting.

The article rightly concludes that transparency is important when evaluating the public testimony in support or in opposition to new therapies. However, to simply conclude that industry has “hijacked’ the microphone risks overlooking one of the primary problems of the advisory process: for many patients – the people who stand to directly benefit from these new therapies – the “microphone” has always been out of reach. Even when patients do get the mic, they don’t always seem to be given one that’s plugged in.  

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Instead of arguing for greater transparency, perhaps we should be focused on the underlying problems and ways to solve for them. This begins with a recognition that public testimony is an important part of the Advisory Committee process. It provides the Advisory Committee members with a perspective not necessarily covered in the sponsor presentation of their data or the FDA’s interpretation of that data. Patients can help the Advisory Committee members understand how they consider the benefits versus the risks of a new therapy, in addition to how that therapy may (or may not) improve quality of life in a way not entirely evident through presentation of the narrow lens of the data.  

The way Advisory Committee meetings are currently structured the patient’s voice is treated as more of an afterthought. The time for public testimony is limited, and often patients who apply to testify are not given an opportunity. Those who are selected are usually given 3-5 minutes each to make their case.  Testimony must be given in person, presenting a tremendous barrier to patient participation. Surely with the technology available today, FDA might want to consider providing a way for patients to deliver their testimony via video.    

Last fall the FDA announced it was forming the Patient Engagement Advisory Committee (PEAC) that would consider the agency’s work from a patient centered perspective. A post about the FDA’s decision on their blog noted that, “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.”  

That’s absolutely right. I hope the PEAC will start by considering new ways to engage patients in the FDA’s advisory committee process. I hope they look into how technology can be used to reduce some of the barriers to patient engagement. I hope they will look to ensure patients’ voices, like experts’, are clearly heard, and also that their conflicts of interest, like experts’, are clearly identified.

Ultimately I hope, like Dr. Prasad, to see a microphone in the hands of the patients. 

Tepp is a principal at HCM Strategists, a Washington, DC-based policy and advocacy firm that ensures patients are included as true partners in policy and regulatory conversations. She has over twenty years of experience working to include patient voices in critical conversations.