ABOUT THE BILL

The Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023, or the BENEFIT Act, is designed to improve the integration of patient experience data into the FDA’s drug approval process. This legislation requires the FDA to consider relevant patient experience data, which includes insights into how patients experience their conditions and respond to treatments, when evaluating the risks and benefits of new drugs. 
By mandating that the FDA publicly disclose how this data is used in the approval process, the BENEFIT Act ensures greater transparency and allows stakeholders to understand the impact of patient perspectives on drug evaluations. This approach aims to create a more patient-centered drug approval process, resulting in treatments that are more aligned with the real-world needs and experiences of patients. 
The Act benefits patients by ensuring that their experiences are considered in the development of new therapies, caregivers by providing more informed options for managing care, healthcare professionals by offering updated insights into treatment effectiveness, researchers by encouraging patient-centric research, and medical educators and students by incorporating practical, real-world data into their learning.

CURRENT SITUATION & ISSUE

The current drug approval process often lacks sufficient incorporation of patient experience data, which is crucial for assessing the real-world impact of new treatments. The Food and Drug Administration (FDA) evaluates drugs primarily through clinical trial data, which might not fully capture how a drug affects patients’ everyday lives. 
As a result, some drugs may be approved without fully addressing patient needs or preferences. This gap in consideration can lead to suboptimal therapeutic options and reduced alignment between drug benefits and patient experiences.

HOW THE BILL FIXES IT

The BENEFIT Act addresses the issue of inadequate consideration of patient experience data in the drug approval process by mandating that the FDA include relevant patient experience data in its risk-benefit assessment framework for new drug approvals. This requirement ensures that the real-world impacts and preferences of patients are considered alongside clinical trial data. 
By integrating patient experience data, the Act promotes a more comprehensive evaluation of new treatments, leading to approvals that better reflect the actual benefits and challenges faced by patients. Additionally, the Act mandates that the FDA publicly disclose how patient experience data influenced its decision-making, enhancing transparency and informing patients, healthcare providers, and other stakeholders. 
This approach aims to foster drug development that is more closely aligned with patient needs, ultimately resulting in therapies that are more effective and relevant to those they are designed to help.

WHAT IT SEEKS TO DO

The BENEFIT Act seeks to enhance the drug approval process by ensuring that the FDA incorporates patient experience data into its risk-benefit assessment framework for new drug approvals. 
By mandating the inclusion of this data, the Act aims to improve the alignment between new treatments and the real-world needs and preferences of patients. This will lead to more comprehensive evaluations of drug effectiveness and safety, ensuring that approved therapies address the actual challenges faced by patients. 
Additionally, the Act requires the FDA to publicly detail how patient experience data influenced its approval decisions, promoting transparency and better informing stakeholders about the drug evaluation process.
• Risk-Benefit Framework: Mandates that patient experience data be considered in the FDA’s risk-benefit assessment for new drugs.
• Comprehensive Evaluations: Ensures that evaluations reflect real-world impacts and patient preferences.
• Public Disclosure: Requires the FDA to publicly describe how patient experience data influenced its drug approval decisions.
• Informed Stakeholders: Provides clarity to patients, healthcare providers, and the public about the role of patient data in the approval process.
• Patient-Centric Approaches: Encourages drug developers to incorporate patient experiences into the development process.
• Improved Alignment: Promotes the creation of therapies that better address the actual needs and challenges faced by patients.

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