Charleston, S.C., Dec. 5, 2017: The International Hyperhidrosis Society hosted a landmark Patient-Focused Drug Development (PFDD) Meeting for Hyperhidrosis in Washington, DC on November 13, 2017.
This meeting provided hyperhidrosis patients’ with a platform to make their voices — and needs — heard by treatment developers, healthcare providers, and regulatory professionals from the U.S. Food and Drug Administration (FDA).
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.”
As part of this hyperhidrosis PFDD process and the post-meeting commenting, 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.
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. This PFDD process marks an important milestone in the movement to provide crucial insights into what hyperhidrosis sufferers really need.
During the PFDD meeting, 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 there are definitive, highly tolerable treatments that address the full range of hyperhidrosis patients’ needs.
Here’s how hyperhidrosis sufferers participated:
- They REGISTERED to be among the 300 hyperhidrosis community members to attend the IHhS-led PFDD via webcast.
- They're BEING HEARD as part of the science of patient input. Open commenting is available NOW. How does Hh impact life? What’s needed in a treatment? Public 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 continues for two months (until Jan. 13, 2018). Comments can be emailed using the subject line “PFDD Comments.”
- They're SPREADING THE WORD. You can too. Share this page so the PFDD Open Comment period gets diverse, comprehensive hyperhidrosis input.
PFDD events, like this, 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 patients’ lives are made.
Wherever hyperhidrosis patients live, this PFDD process may impact them. The innovations and standards set in the U.S. can have ripple effects for hyperhidrosis awareness, treatment, and regulation around the world.
Guess what? Not only did the milestone PFDD take place on November 13, but November 2017 was also designated as the first annual Hyperhidrosis Awareness Month!