ABOUT THE BILL

The STAT Act (H.R. 1730/S. 670) is a bipartisan and bicameral initiative designed to enhance the development and accessibility of therapies for individuals with rare diseases. This community-driven bill aims to introduce meaningful policy reforms within the Food and Drug Administration (FDA) to expedite the creation of treatments for a broad range of rare conditions and ensure that patients can readily access these therapies.
The STAT Act proposes the establishment of a Rare Disease Center of Excellence within the FDA to improve coordination and engagement among stakeholders. It seeks to create a Rare Disease and Condition Drug Advisory Committee to guide policy decisions and actions related to rare diseases. Additionally, the bill aims to provide funding for regulatory science and related activities, supporting the development of therapies for very small patient populations. By bolstering patient access to FDA-approved treatments through public and commercial health plans, the STAT Act strives to make significant strides in addressing the unmet needs of the rare disease community.

CURRENT SITUATION & ISSUE

The development and approval process for therapies targeting rare diseases is often lengthy and complex. Patients with rare diseases frequently face limited treatment options due to the small number of individuals affected by these conditions, making it less profitable for pharmaceutical companies to invest in research and development.

HOW THE BILL FIXES IT

The STAT Act addresses the lengthy approval process by providing additional resources to the FDA, establishing clearer guidelines for rare disease drug approval, and promoting collaboration among researchers, patients, and pharmaceutical companies. This will lead to more efficient development and availability of treatments for rare diseases.

WHAT IT SEEKS TO DO

The STAT Act aims to accelerate the development and approval of therapies for rare diseases. The bill proposes to enhance the FDA’s ability to review and approve new treatments more swiftly by creating streamlined pathways for drug development. It also seeks to improve coordination and communication between stakeholders involved in the development of rare disease therapies.
• Accelerate rare disease therapy development by expanding existing authority within the FDA to create a Rare Disease Center of Excellence.
• Optimize interagency coordination by creating a Rare Disease and Condition Drug Advisory Committee.
• Advance science-based regulatory policies to support development of therapies to treat very small rare disease populations.
• Facilitate access to therapies in both public and commercial plans.

HOW THIS LEGISLATION BENEFITS OUR COMMUNITIES

NEXT STEPS TO ADVOCATE FOR IT

1.

Find the Legislation and Check the Status
To begin your advocacy efforts, it’s essential to know the current status of the bill. This involves identifying the bill numbers and checking the progress which you can do by clicking on the button below which will take you to our “Search & Track Legislation” page. Understanding where the bill stands—whether it has been introduced, is in committee, or is up for a vote—will help you tailor your advocacy efforts accordingly. Okay now don’t close the tab with this open, you will need it for step 3.
FIND THE BILL

2.

Find & Get Contact Info For Your Representatives
Identifying your federal and state representatives is crucial for targeted advocacy. You can use our “Find Your Representatives” page by clicking the button below to find your representatives’ contact information, including their phone numbers, email addresses, and office locations.
FIND YOUR REPRESENTATIVES

3.

Check If Your Representatives Are Cosponsoring the Bill
Cosponsoring means that a representative or senator has added their name in support of the bill, indicating their endorsement and helping to build momentum for its passage. Remember that page from step 1 that you pulled up with the information about the bill? That is where you can also look up your representatives on the bill’s page to see if they are listed as cosponsors. If they are already cosponsors, then you don’t need to do anything since they already support it, (if you want to though you thank them for their support). If they are not co-sponsors, then continue on through the steps which will help guide you to encouraging them to become cosponsors.
CHECK COSPONSORSHIP

4.

Create A One-Pager
Now that you know that your representative is not already supporting this bill, you can create a one-pager prior to contacting them so that you have it ready to go should you need it quickly. If you have not heard of a one-pager before, a one-pager is a concise document summarizing the key aspects of the bill. This should include a brief summary of the bill, its benefits, relevant statistics, and a personal story to humanize the issue. The one-pager should also contain a clear call to action, specifying what you want the reader to do. It might seem intimidating, but don’t worry we created a template and guide over on our one-pager page which you can access by clicking the button below.
CREATE A ONE-PAGER

5.

Contact Your Representatives
Now that you have all the info and one-pager, it is time to contact your representatives! You can learn all about this process and access resources and guides as to what to do on our, “Contact Your Rrepresentatives” page by clicking the button below. You can prepare your talking points using your one-pager, then reach out to your representatives via email, phone calls, or by scheduling a meeting. You can then explain why this bill is important to you, how it impacts you or those you care about, and request their support. You can then provide them with your one-pager for them to have and reference after.
CONTACT YOUR REPRESENTATIVES

6.

Share About The Bill On Social & Mainstream Media
Personal stories can be powerful advocacy tools. You can use our social and mainstream media toolkits to help you share about the bill, about your own experiences with the issue and how the passage of the bill would improve your healthcare. You can then go on to highlight the broader impact on patients with chronic, complex, and rare diseases. You can do this on social media as well as mainstream media to help make others aware of the legislation. While sharing about it, you can also provide resources, like this page, to help them each take action with their own representatives. This can help to get more representatives involved and move the process of the bill getting passed forward.
MEDIA TOOLKIT