The FDA has refused Stealth BioTherapeutics’ request to reconsider its application for elamipretide—despite earlier indications from FDA reviewers that such a request was appropriate. Instead, the FDA has instructed Stealth to resubmit under the accelerated approval pathway with a 6-month review timeline, the longer of two options. This delay, coupled with financial constraints facing Stealth, puts the future of elamipretide—and the Expanded Access Program (EAP) through which patients currently receive it—at serious risk. Without immediate action or a shortened review, access could end as soon as September, leaving individuals with Barth syndrome and other mitochondrial diseases without the only treatment shown to improve symptoms.
We are calling on the community to advocate by participating in Elamipretide Action Week and the social media #ShotsForShotsChallenge. We have outlined a week of ways to participate in advocacy from anywhere, from August 18 through 22, to convey the urgency and to keep elamipretide at the forefront. Every voice matters—together, we can push for the urgent action needed to preserve access to this critical therapy.
Mail Your Reps Monday
August 18 is Mail Your Reps Monday
Option 1: Contact Electronically
1. Send the FDA and your Legislators an email
Option 1: The simple approach to send an email to the FDA and your Legislators is by simply completing this form which contains the content of the suggested template provided below.
Whether sending a message through the Phone2Action form or from your email address, it is always helpful to personalize your message.
This is your message. We are just trying to make this as easy as possible for you to make this ask. If you would prefer to write your own letter, GO FOR IT!
Option 2: Do it yourself (steps as follows)
- Find your Member by entering your contact information in this Phone2Action form
- Click Find Legislators
- Select the name of the Legislator
- Select the way that you wish to contact the Member
- Website which leads to their email form
- Tweet
- Call the DC office with the number provided in the search
In addition to sending a message through the email form, it’s always a good idea to send a direct email to one of the staff members. Please contact Shelley Bowen so BSF can help connect you with the appropriate staff members in your Representative's office.
Option 3: Contact Your Legislators by Snail Mail
If you would like to write a physical letter to your Legislators, you can find their addresses on this website by using the search function.
A letter template to contact your reps can be found here.
A letter template to contact the FDA can be found here.
- Find your Members by entering your address and clicking the magnifying glass
- You will be redirected to a new page where the right-hand side will populate your Legislators alongside their mailing addresses.
