ABOUT THE BILL

The Creating Hope Reauthorization Act H.R. 7384 aims to extend the priority review voucher program until Fiscal Year 2029. This program is designed to incentivize pharmaceutical companies to invest in the development of treatments for rare pediatric diseases by offering a significant benefit—a priority review voucher. This voucher entitles the holder to a priority review of a single new drug application, allowing for a faster FDA review process. The expedited review can significantly shorten the time it takes for new therapies to reach the market, providing patients with earlier access to potentially life-saving treatments.
The extension of this program through H.R. 7384 continues to address a critical need in the rare disease community. Many rare pediatric diseases, which affect fewer than 200,000 individuals, have limited or no existing treatment options. The priority review voucher program serves as a powerful incentive for drug developers to focus on these neglected areas by providing them with a tangible benefit that can facilitate the development and approval of new therapies.

CURRENT SITUATION & ISSUE

The FDA’s priority review voucher program is designed to incentivize the development of drugs for rare pediatric diseases by offering an expedited review process. This program is currently set to expire, potentially limiting the incentives for manufacturers to invest in these critical treatments.
 

HOW THE BILL FIXES IT

By extending the priority review voucher program, the Creating Hope Reauthorization Act maintains an important incentive for drug manufacturers to develop and seek approval for treatments targeting rare pediatric diseases. This ensures that these drugs receive expedited review, potentially leading to faster availability for patients.
 

WHAT IT SEEKS TO DO

The Creating Hope Reauthorization Act (H.R. 7384) seeks to extend the priority review voucher program, which incentivizes pharmaceutical companies to develop treatments for rare pediatric diseases, by authorizing the program until Fiscal Year 2029. This program provides drug manufacturers with a priority review voucher that allows for an expedited review of a new drug application by the FDA, significantly accelerating the approval process for new therapies. By extending this program, the Act aims to continue encouraging the development of new treatments for rare diseases affecting fewer than 200,000 people, particularly those impacting children, thereby addressing critical unmet medical needs and facilitating faster access to potentially life-saving therapies.
• Extend the Priority Review Voucher Program: Continue the incentive program that provides priority review vouchers to drug manufacturers developing treatments for rare pediatric diseases.
• Incentivize Development of Rare Pediatric Disease Treatments: Encourage pharmaceutical companies to invest in and develop new therapies for rare diseases affecting fewer than 200,000 people, particularly those impacting children.
• Accelerate FDA Review Process: Facilitate faster approval of new drugs by granting voucher holders expedited review by the FDA, thus reducing the time to market for critical treatments.

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