As we reported earlier this week, ARS Pharmaceuticals has received word from the FDA that neffy® — their needle-free intranasal epinephrine device — has advanced to an advisory committee. While this is great news, there is no guarantee the device will pass the advisory phase without help from the public.
The committee and the FDA value the opinion and testimony of stakeholders like you who understand how children, adults, and their families are impacted by severe allergy risk and may have insights into the availability of new treatment options.
Your testimony is important and there are two ways you can participate.
- Written testimony submissions can be made directly to the panel via the Federal eRulemaking Portal (docket number FDA-2023-N-0984). The deadline for written submission to the advisory panel is April 17th.
- Oral testimony can be given virtually. You can request 2-3 minutes to express your thoughts live the day of the meeting. The request to express your thoughts live needs to be made via email to the FDA staff by contacting Takyiah Stevenson at PADAC@fda.hhs.gov, by April 12th.
There are a number of topics you may wish to cover including:
- What it’s like for those who live with severe allergy risk and their families;
- How severe allergy risk impacts children, adults, and their day-to-day quality of life;
- The benefits and challenges associated with current treatments;
- How auto-injectors and syringes impact patient compliance with the carrying and use of epinephrine;
- How different delivery systems could impact patient compliance and the ability of patients to manage their severe allergy risk.
Testimony from parents, patients, and caregivers is critical to providing the FDA proper context to consider intranasal epinephrine alongside needle-based devices.
Please lend your voice!