The FDA heard us loud and clear

| Kathryn Jones

Everyone living with psoriatic disease has their own opinion on the effectiveness, affordability and potential side effects of their treatment options. So if you could be in a room with the U.S. Food and Drug Administration (FDA) – the decision-makers behind which medications are made available to patients – what would you say?

Aimes Vasquez recently had that chance. She told them, “You name it, I’ve done it. I tried biologics. After a while, they stop working. I gave up hope thinking they were all the same. I just want a medication with no side effects that will give me total clearance.” 

On March 17, the FDA held a day-long patient-focused drug development (PFDD) meeting focused exclusively on psoriasis. The goal was to collect patient perspectives on treatments and learn about the ways psoriasis impacts our everyday lives. 

“We at the FDA are aware of unmet medical needs experienced by patients who have psoriasis,” said Jane Liedtka, MD, of the agency’s Division of Dermatology and Dental Products (DDDP) at the Center for Drug Evaluation and Research.

The FDA wants to know from patients how well they fare on treatments currently available in the marketplace, how symptoms of their disease – such as itch or plaques – affect their everyday lives and whether alleviating some of these symptoms is worth the risk of the potential side effects noted on black box warnings.

“It is our responsibility to make sure the [benefits of] treatments outweigh the risks,” said DDDP Director Kendall Marcus, MD, who facilitated the meeting. “We look forward to incorporating what we learn today into the agency’s thinking.”

FDA recognizes patient needs

Psoriasis is one of only 24 diseases selected to be topics of these patient-focused meetings, which started in 2013 and will conclude sometime next year. HIV, breast cancer, Parkinson’s Disease and fibromyalgia are among the other PFDDs hosted by the agency. 

“We’ve been busy laying the groundwork for this unprecedented meeting since fall 2014, when, in collaboration with the division at the FDA that reviews dermatology products, NPF brought leaders in the psoriatic disease field to a meeting attended by more than 40 FDA doctors, biostatisticians, epidemiologists, toxicologists and other staff,” said Leah Howard, NPF vice president of government relations and advocacy. “When the FDA asked for recommendations for disease area topics, nearly 2,700 people suggested more than 50 diseases. NPF and LEO Pharma proposed a psoriasis meeting, and the agency agreed on the need.” 

The overwhelming response from patients across the country cemented that need. At final count, more than 140 people registered to attend the meeting in person and more than 200 people opted to participate online through a live webcast. The FDA later said it was the biggest response it’s received from a patient disease community thus far.

We made a lasting impression 

The PFDD meeting was divided into two topics: 

  1. Disease symptoms and daily impacts 
  2. Patient perspectives on treatment approaches

For each topic, the FDA hosted a panel of patients who offered their personal stories and opinions. This was followed by a commentary period from patient members and caregivers in the audience, as well as individuals phoning in. 

What resulted was a candid conversation about some of the hardships of living with this disease that most of us are too ashamed to discuss – from coping with genital psoriasis to being quarantined as children because people thought it was contagious. 

The courage it took for panel participants and audience members to share such personal accounts not only unified the room, but at times, visibly affected members of the FDA, a relatively stoic-looking bunch whose face expressions often gave way to sympathy and shock.

A resounding theme was what little the medications do to relieve the everyday nuances associated with the disease. “My experience is that the biologics have really helped but it never stops the itch,” Caleb Sexton said, adding, “I have single-handedly bankrupted my family trying to pay for my health care.”  

At one point, the FDA asked how many people in the audience were itching or in pain at that very moment, and nearly everyone in the room raised their hand. “Based on the type of questions the FDA is asking, it really seems like they are listening to what we have to say,” Renee Andrews remarked.

Now it’s your turn to talk

The FDA didn’t just listen to what we had to say, we piqued its curiosity. The agency is still asking for input from the public on the two aforementioned topics. The FDA has also expressed an interest in hearing more from parents of children living with psoriasis as well as people who have participated in clinical trials. Health care providers are invited to offer input, too, by sharing what they hear from their patients.

Click here or visit: and type in “psoriasis patient focused drug development” to offer your input.

Commentary on the public docket remains open until May 17. Stay tuned for fall 2016 when the FDA releases its “voice of the patient report” summarizing its takeaways from the PFDD meeting.

By the numbers

Throughout the meeting, members of the audience and people participating online were polled by the FDA, and the results were reported in real-time. Here are some interesting takeaways:

  • Have you ever been diagnosed with psoriatic arthritis? 59 percent said yes
  • Where is your psoriasis located? 85 percent said scalp
  • What are the most bothersome impacts the disease has on your everyday life? 59 percent said emotional impacts
  • When considering a new treatment for psoriasis, which of the following benefits would you consider to be the most meaningful? 64 percent said reduced itching and flaking
  • Which two would you rank as most important to your decisions about using treatments to help reduce or control the spread of your psoriasis? 64 percent chose whether the drug showed effectiveness, 44 percent was access to treatment (such as insurance coverage) 31 percent said possibility of rare but dangerous side effects

Driving discovery, creating community

For more than 50 years, we’ve been driving efforts to cure psoriatic disease and improve the lives of those affected. But there’s still plenty to do! Learn how you can help our advocacy team shape the laws and policies that affect people with psoriasis and psoriatic arthritis – in your state and across the country. Help us raise funds to support research by joining Team NPF, where you can walk, run, cycle, play bingo or create your own fundraising event. If you or someone you love needs free, personalized support for living a healthier life with psoriatic disease, contact our Patient Navigation Center. And keep the National Psoriasis Foundation going strong by making a donation today. Together, we will find a cure.

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