Hello Friends,
ITSAN has been part of a team working on an incredible opportunity for our community to speak out to the FDA! This September, we will be one of 5 eczema-related patient organizations that will be hosting a meeting with the FDA highlighting eczema! This will be great time to communicate how the long-term use of topical steroids has affected our health and lives and to make a clear appeal to re-evaluate this class of drugs and to change product labeling that would include clearer warnings and guidelines. This meeting is a giant step of paramount importance in changing the way topical steroids are understood, prescribed by doctors, and used by patients. And you, yes YOU, can get involved to make a difference!
This will be an Externally-led Patient Focused Drug Development Meeting on Eczema taking place September 23, 2019, near FDA headquarters, just outside of Washington DC. The other hosting organizations that comprise our team are: The Allergy & Asthma Network; The Asthma and Allergy Foundation of America; Global Parents for Eczema Research; and the National Eczema Association.
To give you a little background, Patient Focused Drug Development (PFDD) meetings with the FDA were developed to ensure that patient's experiences, perspectives, needs and priorities are captured and meaningfully incorporated into drug evaluation and development. Since patients and caregivers are experts in what it is like to live with this condition, they are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.
The full day meeting will feature a series of facilitated panel and audience discussions, and a webcast with live polling, focused on providing the FDA and other stakeholders with patient and caregiver views on key issues such as: - The burden of the condition (physical, sociological, psychological) and its impact on daily health-related quality of life
- Current treatments – how they are working or not working (this is where we bring to light our experience with TSW/RSS)
- Benefits that patients with eczema are looking for in future treatments and the risks they are willing to assume in return for more advanced interventions
- Participation in clinical trials and ideas on trial design to make them more appealing to people with eczema.
In addition to around 10-15 panelists, our team is hoping to have 150 eczema patients and care-givers in the room, who will be able to participate in audience discussions. Those who are not attending the meeting in person have the opportunity to join via live webcast so that they also can also participate in polling and the discussion. If you live in the US and are interested in joining the meeting in person, travel assistance is available.
IMPORTANT!!!:
In preparation to the meeting on the 23rd, we are asking everyone to please file an adverse drug event report with the FDA if you haven't already done so. To date, over 450 ITSAN community members have filed a report – this is a great start, but could you imagine the impact if thousands have filed?!? Not only will the FDA hear our stories and see our pictures, face to face, but they will also have related data in their own system to document this real-world evidence as they follow up on our requests.
So, if you haven't, please take 5 minutes to fill out the FDA's "Med-watch Voluntary Report" to help galvanize this movement. You don't have to live in the US to do so. The following link will take you to the FDA site: Once there, click the blue box on the right that says: Consumer/Patient (FDA Form 3500B) to begin!
Stay tuned in the next couple of days for more details on how to apply to attend the PFDD meeting in person or by live webcast.
I can't stress enough how important it is that YOU raise your voice. There is so much strength in numbers!!! Together, we can bring accountability - ensuring that these medications are properly understood, prescribed, and used to end the terrible suffering of TSW that so many of us have endured. Together we can end this!!
Kelly Barta, ITSAN President Pictured above with 2 other leaders of the PFDD Planning committee, Korey Capozza and Keri Kelley, from the Global Parents for Eczema Research at the Eczema Expo last month. | | | | | Have you been helped by ITSAN? Please consider making a donation so that we can continue our work in raising global awareness and supporting those suffering from TSW/RSS. ITSAN is funded solely by contributions from people like you. Your gift could make all the difference in someone's life!
Click here to make a donation: https://itsan.org/donate/ | Please find support for your Red Skin Syndrome in the ITSAN public forum or Facebook RSS support group. ITSAN does not medically advise and only permits sharing of personal experiences. Anything advised or suggested by support group members is not necessarily endorsed by ITSAN. If you ever shop on Amazon.com, please take a minute to select ITSAN as your favorite charity in the Amazon Smile program. ITSAN will receive 0.5% of every purchase you make! On your first visit to AmazonSmile, you simply need to select International Topical Steroid Addiction Network as your designated charity to allow ITSAN to receive donations from your purchases. Once you do that, be sure to choose AmazonSmile.com for future visits. Amazon will remember your selection, and then every eligible purchase you make will result in a donation. Click on any Amazon Smile in this box to get started today! ITSAN appreciates your support!
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