On March 8, 2021, FDA hosted a virtual public meeting on Patient-Focused Drug Development for Vitiligo. FDA was interested in hearing patients’ perspectives on the impact of vitiligo on daily life and patient views on treatment approaches. In this news article we catch up with event attendees to reflect on the event, and also share how you can still influence this groundbreaking moment for our global vitiligo community.
The significance of the event for people in the UK
The FDA has formal and informal relationships with their foreign counterparts across the globe. The FDA’s international programs have grown and its experts are often called on to direct, manage and coordinate the growing body of international work involving the World Health Organisation and International Conference of Drug Regulatory Authorities. Although we have our own regulatory bodies in the UK, developments in the US will without doubt influence decision making across the world. This was an excellent opportunity for people living with vitiligo in the UK to speak alongside the US community and be heard by a key player in vitiligo treatment decision making.
What we took away from the event
This event was an incredible recognition of the great work medical professionals and patient support groups are doing in the US to raise awareness of vitiligo and the need for better treatments. It sets the bar for what we need to be doing with our own regulatory bodies in the UK to give better treatment options for our own vitiligo community.
Dr Richard Huggins shares his reflections with us
Now specialising in vitiligo, Dr Huggins first came across the condition in medical school in 2004. He was struck by how common the condition was and how many unanswered questions there are. Currently working in the Henry Ford dermatology department in the US, Dr Huggins is also Chairman of the Vitiligo Support section of the Global Vitiligo Foundation.
How significant do you think the event was for our global vitiligo community?
‘I thought it was one of the most important things that has happened to the vitiligo community ever. The fact it even took place, shows vitiligo is now high on the FDA radar. The FDA has only had around 30 patient focus meetings like this, only 3 of which were dermatology focused. What is really exciting is how organically this meeting happened, the FDA heard about the growing interest in treatments, support group growth and the increased awareness of the condition, and all this culminated in the FDA deciding it needed to hear directly from people living with vitiligo.
This is a big moment for the vitiligo community to recognise that their condition is important to the US government, and that the government is acknowledging that more attention and treatment is required.
For me, an unexpected benefit of the event was all the unifying discussions prior to the meeting. Support groups came together to talk strategy and how to maximise the impact of the event. These conversations really bought the community together, and led to further discussions on how to work more collaboratively in future.
Over 1000 people registered, 700 of which had vitiligo and 300 of which were from industry (pharmaceutical companies) or were medical professionals – to have all these people wanting to learn and hear more about how vitiligo affects people, and gaps in treatment, was incredible.’
Did you have any perceptions that were challenged by the event?
‘I have worked with local vitiligo support groups for 12 years, and worked nationally for 7 years – so I thought I really understood the impact of vitiligo. Hearing individuals share their experiences at the event really deepened my understanding of the personal impact of the condition.
I left the meeting with an even greater appreciation for the extent to which vitiligo affects people’s lives. I knew ahead of time that the treatments don’t always work, but hearing first hand how ineffective, slow working, messy and disruptive treatment can be – I truly understand now that we have a long way to go in terms of developing the effective, practical treatments and the cure that people need.’
What will you be taking away from the event?
‘Physicians, myself included, need to communicate better to colleagues that don’t specialise in vitiligo. So many people going to a doctor are being dismissed for it being cosmetic or untreatable. We need to encourage our colleagues to speak with empathy, understand the impact of vitiligo, and have a better awareness of the treatments that are available.’
Any final comments?
‘For me the purpose of the meeting was to inform the FDA’s risk-benefit analysis when a pharmaceutical company seeks FDA approval for new treatments. The meeting was really successful in showing the need for new treatments but patients need to make it clear their risk-tolerance for new treatments and studies.
The FDA is still open to comments from the event, so I hope everyone in our vitiligo community will take this opportunity to share their thoughts on the need for new treatment development.’
Alicia Roufs shares her thoughts with us
Alicia Roufs is the marketing director of a US based national non-profit group called VITFriends, a vitiligo support community. She is also the founder of the local VITFriends support group in Minnesota which currently has 250 members. Alicia has had vitiligo for over 43 years.
Why did you feel it was important to attend the event?
‘I have spent many years telling people that vitiligo is NOT a cosmetic condition! We have fought hard to have medical people, pharmaceutical companies, and elected officials to take vitiligo seriously and recognised it as an autoimmune disease. So attending a 1st ever FDA drug development meeting was history in the making for vitiligo.’
As someone involved with vitiligo support groups, how significant do you think this was for people living with vitiligo?
‘I think the significance of the event was groundbreaking. Finally we have a huge government agency recognizing vitiligo as a serious condition that needs their attention. We have heard in the past that these FDA meetings have led to huge changes for other diseases that included large funding for research and better drug developments.
It was great to hear stories of the 10 panelists and 6 conversation starters. I was asked to be one of the large group conversation starters, so I was able to share my story briefly. It was an honor to be a part of it. There was also an option for people to call in, and we heard several amazing stories of struggle and hardship that people have gone through with vitiligo. I’m hoping this will leave a huge mark on the FDA representatives’ hearts.
The downside I had of it was not being able to see everyone’s faces and not knowing how many people were actually on the webinar. We were told 1020 people had registered. So that was a bummer. I also wasn’t a huge fan of some of the survey questions.’
Do you have any last reflections to share with us?
‘I really hope and pray that this will make headway for new therapies for vitiligo or for FDA to approve already used practices for vitiligo.’
Join your voice to the cause
The key question for the FDA to gauge is whether the vitiligo community would prefer to see more approved treatment options (even if these options may not provide a permanent, effective and risk free treatment for everyone), or if the most important thing is for only perfect, guaranteed treatments to be approved.
The deadline for leaving comments 10th May 2021, so it’s not too late to have your say and join your voice with the 1000’s of people who attended the meeting.
You can view the full recording from the event here
You can submit you comments about the event here
