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Cheers to the end of the season and for making it through the dog days of summer! Here is a look ahead at what you can find in this month's newsletter and ways to
continue your engagement:
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Interested in adding your voice to the FDA's decision-making process or finding resources for children going back to school? Register for the FDA's webinar here or NAAF's webinar here.
However you choose to engage, thank yourself for the work you've done thus far in 2024; we've accomplished much and continue to have lots of good work ahead of us to affect positive changes for those with skin disease.
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Legislative and Policy Updates | |
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PBM Transparency
In July, the U.S. House of Representatives Committee on Oversight and Accountability released a report, "The Role of Pharmacy Benefit Managers in Prescription Drug Markets." The report finds that Pharmacy Benefit Managers (PBMs) "inflate prescription drug costs and interfere with patient care for their own financial benefit."
The report contains several key findings, which among them includes:
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"PBMs frequently tout the savings they provide for payers and patients through negotiation, drug utilization programs, and spread pricing, even though evidence indicates that these schemes often increase costs for patients and payers."
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"The largest PBMs’ use of tools such as prior authorizations, fail first policies, and formulary manipulations have significant detrimental impacts on Americans’ health outcomes."
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"The anti-competitive policies of the largest PBMs have cost taxpayers and reduced patient choice."
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ACTION ALERT – Summer Advocacy
August is a key month to meet with your legislators locally to educate them about skin diseases and to ask for their assistance with key legislative and policy issues!
Here is how you can connect with your legislators, share your personal story, and reiterate the importance of their support for patients living with skin conditions:
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Identify your Representative in the House and your two Senators in the Senate using this link.
- Call their district office to make an appointment while they’re in their home district.
- Attend a constituent meeting (e.g., town hall, coffee, meet and greet).
- Send a letter or e-mail with your personal story and the CSD’s legislative priorities and “asks.”
Please click here for a full list of the CSD’s legislative priorities and congressional “asks," and please click here to access the CSD's Advocacy Toolkit. You do not need to be an expert in government to be effective, you just need to be willing to tell your story!
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Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases
The FDA's Center for Biologics Evaluation and Research (CBER) is excited to host a listening meeting next month for patients and Caregivers. The objectives of this meeting are to hear from patients and care partners on their perspectives on short-term and long-term risks of approved gene therapy products, to learn what types of information patients would find helpful in their decision-making when considering gene therapy, to learn about their considerations and experience of participating in post-market long-term follow up studies, and to help inform patient-centered protocols for long-term follow up of gene therapy products.
The meeting will be divided into two sessions and patients, advocates, and caregivers are encouraged to request to speak during the registration process. The deadline to request to speak is Friday, August 30, 2024 at 11:59 PM ET.
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Date: Friday, September 20, 2024
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Time: 11:00 AM.–4:30 PM ET
- Location: This free virtual listening meeting will be hosted on Zoom.
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Registration: Registration is required.
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Register here.
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Embarking on a new school year can be an overwhelming experience for many students. However, the challenges can be particularly daunting for children dealing with alopecia areata.
Don't miss the opportunity to join NAAF’s Support & Education Director, Judy Williams, and experienced parents as they delve into valuable resources and effective strategies to help students thrive in their school environments while coping with alopecia areata.
Gain insights into their personal journeys and discover how these families navigated the implementation of a 504 Plan.
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Date: Tuesday, August 20, 2024
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Time: 7:00 PM ET / 6:00 PM CT / 4:00 PM PT
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Location: Virtual - Zoom
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Free registration at this link.
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CSD is looking forward to exhibiting once again at the Pediatric Dermatology Research Alliance (PeDRA) upcoming annual conference, held at the Sheraton Phoenix Downtown from October 24-26.
The theme for this year’s conference is Innovative Solutions to Advance Pediatric Dermatology Research and will focus on the tools available to support impactful research and how to use them. The PeDRA Annual Conference is an opportunity to connect and collaborate with dedicated scientists, trainees, industry partners, patients, and advocates to advance research that improves the lives of children with skin diseases and conditions.
PeDRA generously invites our members to join them for this awesome event, which is dedicated to advancing research across all skin diseases and conditions affecting children. For those interested:
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If you are interested in sponsoring the third Dash for Discovery Fun Run/Walk for $250, your logo will go on the website, signage, and high quality long-sleeve shirts, which people seem to love and wear all the time. To sponsor reach out to Mike Siegel.
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Please spread the word amongst your communities for anyone interested in attending the conference and/or Mini Camp Wonder at PeDRA, being hosted for the fourth time by the Children's Skin Disease Foundation. Note that all PeDRA Community Members are eligible to apply for a travel scholarship, and we hope to give out a ton of travel scholarships.
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The CSD is expanding our reach this year to exhibit at the American Academy of Family Physicians (AAFP) FMX annual meeting, SOAR. Did you know that 2/3 of dermatology patients see family physicians? We need to get in front of this group and make them aware of the great resources found in our patient organizations!!
If you are interested in helping "man" the booth and gaining more connections with these doctors, reach out and let us know. We have 2 spaces left to fill.
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Actor Jon Hamm discusses living with vitiligo.
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U.S. Olympic gymnast champion Suni Lee hopes to be a role model for those with eczema.
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Calling All Patient Groups | |
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Would you be willing to share resources to help others in the CSD? Many of our members have mentioned how beneficial it would be to have a repository of helpful guides they could glean from to inform their own work and minimize the need to start from scratch, which would save tons of precious time and elevate our whole community.
If you have templates or examples of organizational policies, fundraising strategies, patient conference planning, email drip campaigns, and the like, please share them! You can easily upload those documents here.
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FDA Announces Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients
Recent rapid advances in the identification of promising drug targets and development of gene therapies offer momentum and potential to meet the needs of patients with rare diseases. In 2023, over half of all the novel drugs and biologics approved by the FDA’s Center for Drug Evaluation and Research (CDER) and the FDA’s Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease or condition. Many rare diseases lack treatment options and therefore many patients have high unmet medical needs. This requires new approaches to expedite development and approval of safe and effective drugs and biologics.
FDA plans to establish a Rare Disease Innovation Hub (the Hub). The Hub will work across rare diseases but will especially focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood, as we recognize that development of therapies for these conditions can be particularly challenging. The Hub would have three primary functions:
- Serve as a single point of connection and engagement with the rare disease community, including patient and caregiver groups, trade organizations, and scientific/academic organizations for matters that intersect CDER and CBER. The Hub will help the larger rare disease community navigate important intersections across the FDA that affect patients with rare diseases, such as medical devices, including diagnostic tests, and combination products.
- Enhance intercenter collaboration to address common scientific, clinical and policy issues related to rare disease product development, including relevant cross-disciplinary approaches related to product review, and promote consistency across offices and Centers.
- Advance regulatory science with dedicated workstreams for consideration of novel endpoints, biomarker development and assays, innovative trial design, real world evidence, and statistical methods.
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Psoriasis Action Month
August is Psoriasis Action Month! Please visit the National Psoriasis Foundation's website to find ways you can support the psoriasis community this month and throughout the year.
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1717 N Street NW, Washington DC, 20036
info@coalitionofskindiseases.org
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The Coalition of Skin Diseases gratefully acknowledges the generous support of our
Healthcare Industry Partners.
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