WASHINGTON, D.C., July 16, 2021 | George Hatamiya (916-201-5412)

WASHINGTON, D.C. – Today, Congresswoman Doris Matsui (D-CA) and Congressman Brad Wenstrup (R-OH) introduced the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act, legislation that would provide patients and patient advocates the ability to play a larger role in the Food and Drug Administration’s (FDA) benefit-risk framework for drug approval.

The BENEFIT Act would amend federal law to ensure that patient experience and patient-focused drug development (PFDD) data is included in FDA’s benefit-risk framework used to inform the evaluation and approval of drug products. This action will send an important signal to all stakeholders that patient experience and PFDD data will be fully incorporated into the agency’s review process and will encourage such entities to develop scientifically rigorous and meaningful tools and data. The legislation would also enhance an important transparency and accountability provision included in the 21st Century Cures Act by requiring the FDA to say how such patient experience and PFDD data was considered within the risk-benefit assessment for any approved therapies. This will provide additional learnings to all stakeholders, particularly patients, and help further refine and develop such tools going forward.

“Patients offer a perspective that is vital to drug development and advancing new therapies,” said Congresswoman Matsui. “Their needs, perspectives and health outcomes are meaningful, and we should look to these individuals as key partners in assessing the benefit-risk of new drugs and biologics. I am proud to introduce this bill with Congressman Wenstrup that would leverage valuable patient experience or patient-focused drug development data in the FDA’s review process.”

“As a physician, it is always my goal to ensure that the patient's voice is heard,” said Congressman Wenstrup. “That's why I'm supporting this patient-centered, bipartisan legislation—to bring the patient and advocate perspective to decision-making process for new innovative breakthroughs and cures.”

The BENEFIT Act is supported by Parent Project Muscular Dystrophy.

“Parent Project Muscular Dystrophy (PPMD) applauds Representatives Matsui and Wenstrup for today’s introduction of the bipartisan, commonsense BENEFIT Act, legislation that will help ensure the patient voice is at the center of the FDA’s review process,” said Pat Furlong, Founding President and CEO of PPMD. “The Duchenne muscular dystrophy community has led the fight to amplify patients’ voices within FDA for more than a decade, and we are encouraged by Congress’s recent actions to ensure reviewers have access to all-important patient experience data. Today’s introduction of the BENEFIT Act is the logical and important next step to build off of the policy progress of laws like the 21st Century Cures Act by ensuring patient data is incorporated into the FDA’s benefit-risk assessment.”

Full text of the bill is available HERE.

Congresswoman Matsui is a member of the House Energy & Commerce Health Subcommittee, which oversees agencies and writes laws pertaining to regulation of food, drugs, and cosmetics. She authored the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which was signed into law in April 2021. The FASTER Act requires sesame to be labeled on packaged foods and prioritizes expanded food allergy research. Congresswoman Matsui also authored the MODERN Labeling Act of 2020, which permits the FDA to require modification of outdated generic drug labels to reflect new information relevant to the use and safety of a drug. The text of MODERN was adopted into the Consolidated Appropriations Act, 2021. Now federal law, MODERN Labeling ensures that providers, patients, and their caregivers have the most up-to-date information about their prescription drugs.  

# # #