Advance Online
Advance Online

The Power of the Patient Voice

Commemorating the 5-year anniversary of the psoriasis meeting at the FDA.

In March 2016, a group of National Psoriasis Foundation (NPF) advocates headed to Washington, D.C., for a Patient-Focused Drug Development (PFDD) meeting with the U.S. Food and Drug Administration (FDA). To many who went, it felt like a familiar trip because NPF and its advocates are no strangers to the Capitol.

Beginning in the earliest days of NPF and continuing to this day, people with psoriasis and psoriatic arthritis (PsA) have used their voices to champion the need for more therapies for psoriasis and PsA before lawmakers and both the National Institutes of Health (NIH) and the FDA. These efforts were integral to realizing advancements in the understanding of psoriatic disease and securing some of the earliest approvals for psoriasis therapies in the 1970s and 1980s, and later the approval of the newer systemic agents used by our community today. [1]

But this 2016 advocacy effort would be different from any of the earlier efforts. In fact, the psoriatic disease community would have an opportunity that only 17 disease communities before them experienced. [2]

On March 17, 2016, these 70 individuals (and more than 160 who joined virtually) participated in an FDA PFDD meeting to inform the FDA about the experience of living with psoriasis. Imagine that: a daylong meeting at the FDA devoted entirely to listening to people living with psoriasis.

Focusing the FDA on Psoriasis

Conducted as part of the FDA PFDD initiative, the aim of these meetings was to provide the agency with a more systematic approach to gathering and documenting patient perspectives on their conditions and available therapies. In late 2014, after more than a dozen initial conversations, the FDA invited input on other conditions that should be included in the initiative. NPF submitted a public comment urging the FDA to hold a meeting on psoriasis. [3]

Although numerous therapies had been approved for psoriasis by then, many in our community were continuing to experience difficulty in managing their disease. Unfortunately, even today too many individuals have greater than the 1% body surface area coverage recommended as a treatment target by the NPF Medical Board. In addition, psoriasis matched the interests of the agency: disease areas that are chronic, symptomatic, or affect functioning and activities of daily living; disease areas for which aspects of the disease are not formally captured in clinical trials; disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions or survives; and disease areas that have a severe impact on identifiable subpopulations.

On July 2, 2015, the FDA announced meetings for psoriasis and seven other conditions. NPF knew there was work to do. [4] For the next 8 months, NPF conducted a campaign to engage the community in the meeting scheduled for March 17, 2016, to take advantage of this once-in-a-lifetime opportunity.

When the day came, you showed up! You spoke candidly. Many of you told stories and shared experiences that you had talked about with few others over the years. Tears were shed. The FDA noted in the Psoriasis Voice of the Patient Report released in November 2016 that “participants reiterated poignantly how psoriasis is much more than a skin rash.” [5] Each of the personal perspectives offered to the FDA made more real the challenges of living with and managing psoriatic disease and highlighted “the immense emotional and social toll the disease can exert on patients’ lives.” [6]

Impact of the PFDD Initiative and Psoriasis Meeting

Although 5 years have passed since everyone gathered in the Great Room on the FDA White Oak campus in Silver Spring, Maryland, your comments that day have not been forgotten. As new therapies have been reviewed by the FDA in the years since, Kendall Marcus, M.D., director of the Dermatology Division of the FDA, has spoken to the learnings from this important meeting, including the impact psoriasis has on career choices and employment, social contacts and intimacy, reproductive choices and fears of relapse. [7]

In 2018, the FDA published a paper reflecting on how the PFDD initiative has advanced the science of patient input. [8] Agency authors noted the way in which the psoriasis meeting and the 23 other gatherings strengthened FDA understanding of the experience of living with a chronic disease, along with the benefits and limitations of treatment. In describing lessons learned, FDA authors specifically cited the psoriasis meeting as an example of how “patients can best identify and articulate what is most important to them regarding treatment benefit.”

Looking Ahead

The patient advocacy community understands that real change takes time. And yet those who have led advocacy work across multiple disease states have noted several ways in which the psoriasis PFDD meeting and others have led to an improved FDA understanding of the patient experience, and that what “we can measure is not always what we should.” [9] Such a recognition makes NPF hopeful that in the review and approval of future therapies, patient considerations will be better reflected in the guidance of the FDA and the decisions around issues such as product labels.

Today, NPF hopes to continue and expand engagement with the FDA and is uniquely positioned to translate your voices into better FDA policies. These efforts will be led by Stacie Bell, Ph.D., NPF chief scientific and medical officer. 

“FDA is committed to integrating the patient experience into product evaluation and approval,” says Dr. Bell. “This is only made possible through collaboration with individuals sharing their stories and advocacy efforts.”

As the psoriatic disease community celebrates the 5-year anniversary of this meeting, thank you again to those who joined us in 2016. We look forward to even greater progress in the next five years.

Speak Up

Let policymakers hear about the ways psoriatic disease impacts your life.

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References

References

1. NPF Advance Online. https://www.psoriasis.org/advance/two-centuries-of-progress-in-one-short-timeline/.

2. FDA. FDA-led Patient-Focused Drug Development (PFDD) Public Meetings. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-pa-tient-focused-drug-development-pfdd-public-meetings.

3. FDA. NPF comment letter. https://www.regulations. gov/comment/FDA-2012-N-0967-0658.

4. Prescription Drug User Fee Act Patient-Focused Drug Development; announcement of disease areas for meetings conducted in fiscal years 2016–2017. Federal Register. Jul 2, 2015. https://www.govinfo. gov/content/pkg/FR-2015-07-02/pdf/2015-16359.pdf.

5. FDA. The Voice of the Patient: Psoriasis. https://www.fda.gov/media/101758/download.

6. FDA. The Voice of the Patient: Psoriasis.  https://www.fda.gov/media/101758/download.

7. FDA. Dermatologic and Ophthalmic Drugs Advisory Committee Meeting. FDA Introductory Remarks. https://www.fda.gov/media/99157/download.

8. Chalasani M, Vaidya P, Mullin T. Enhancing the incorporation of the patient’s voice in drug development and evaluation. Res Involv Engagem 4, 10 (2018). https://doi.org/10.1186/s40900-018-0093-3

9. Food and Drug Law Institute. Taking stock of PFDD: envisioning a vibrant future for Patient-Focused Drug Development. https://www.fdli.org/2020/02/taking-stock-of-pfdd-envisioning-a-vibrant-future-for-patient-focused-drug-development/.

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