Turning the Corner: Patient-Focused Drug Development for Hyperhidrosis
If you do ONE thing to advocate for better treatments for excessive sweating. This is it.
If you’ve ever wondered, how can I make them understand? Here’s how.
The International Hyperhidrosis Society hosted a landmark Patient-Focused Drug Development (PFDD) event in Washington, DC on November 13, 2017 and now the open comment period is your platform to make your voice — and needs -— heard by treatment developers, healthcare providers, and regulatory professionals from the U.S. Food and Drug Administration (FDA). You can email your comments now (learn more below), and if you missed the PFDD, you can watch the webcast.
As Theresa M. Mullin, Ph.D. Director, Office of Strategic Programs for the FDA has said, “Sometimes, the most valuable thing we can do as regulators at FDA is simply to listen.”
PFDDs systematically integrate the science of patient input into treatment development and regulation for medical conditions with significant unmet needs, like hyperhidrosis (excessive sweating). As part of the PFDD process, individuals living with excessive sweating have a high-impact platform to share their challenges, perspectives on treatments (current and future), acceptable risk-benefit profiles, and more.
As you know, hyperhidrosis often exists in isolation, affecting otherwise healthy people – a fact which presents treatment innovators with an opportunity to dramatically change lives… If only they focus on the right things.
There are many glaring gaps in current options for the care and management of hyperhidrosis. Be a part of a patient movement and provide crucial insights into what you really need. During the PFDD event, a panel of individuals directly affected by hyperhidrosis, an audience of an additional 75 hyperhidrosis patients and loved ones, and 300 virtual attendees via live webcast shared their stories and provided invaluable perspective on hyperhidrosis’ impacts and treatments – including needs for the future, experiences with clinical trials, and much more. At least 35 representatives from treatment developers and the FDA were in attendance to listen and take note.
The formal event lasted about 4 hours, but the reports, transcripts, and audio-video materials produced subsequently will be used to inform treatment development and regulation for many years to come – indeed until we find definitive, highly tolerable treatments that address the full range of hyperhidrosis patients’ needs.
Here’s how to be part of needed change:
- Watch the IHhS-led PFDD via webcast.
- BE HEARD as part of the science of patient input. How does Hh impact your daily life? What’s sweat-control worth to you? What do you need in a treatment? Your comments will become part of the Public Record Voice of the Patient – materials that will be used by treatment developers, regulatory professionals, healthcare providers and many others to understand hyperhidrosis, prioritize efforts, and more. Open comment period continues for two months until Jan. 13, 2018. You may email your comments using the subject line “PFDD Comments.”
- SPREAD THE WORD. Share this blog so we can get the most diverse, comprehensive hyperhidrosis input possible.
PFDD events, like this one, have the power to transform the care and understanding of a medical condition and inform assessment of benefit-risk. They illuminate the context in which decisions that affect your life are made. To make the progress you want and need, you need to be part of the process.
Wherever you live, the PFDD may impact you. The innovations and standards set in the U.S. can have ripple effects for hyperhidrosis awareness, treatment, and regulation around the world.
Your voices are the ones that pharmaceutical industry and regulators need to hear.
- Watch PFDD webcast.
- Be heard. Open comment period ends Jan. 13, 2018. Send your comments with the subject line “PFDD Comments."
Guess what? Not only did the milestone PFDD take place on November 13, but November, 2017 was also designated the first annual Hyperhidrosis Awareness Month! See what's next, watch IHhS on Facebook and Twitter and in your email for the latest.
We thank Dermira, RA Fischer, Brickell Biotech, Hidrex USA, and private donors for their generous support and for making this landmark PFDD initiative possible.
IHhS is also grateful for the crucial contributions from Dermira and private individuals for making Hyperhidrosis Awareness Month possible.