PPMD applauds Senators Roger Wicker and Amy Klobuchar and Representatives Doris Matsui and Brad Wenstrup for the reintroduction of the BENEFIT Act, bipartisan legislation conceived by PPMD in collaboration with Congressional Champions that will help ensure the patient voice is at the center of the FDA’s review process. The BENEFIT Act initially passed the Senate in 2017 but further action was deferred as the 21st Century Cures was being implemented.
Now that this bill has been introduced in the new 118th Congress, it’s time for us to raise our voices on Capitol Hill. The BENEFIT Act will be a priority of PPMD’s Advocacy Conference, in-person March 5-7, and virtually during the week of March 13. Join us as a Virtual Advocate and make your voice heard.Become a Virtual Advocate >
About the BENEFIT Act of 2023
The 21st Century Cures Act (P.L. 114-255) includes sections 3001 and 3002, the Patient-Focused Impact Assessment (PFIA), led by our community in 2016, which has accelerated the field of patient-focused drug development (PFDD). FDA now has a number of programs and policies in place to gather and assess patient perspectives within the regulatory review process, and patient advocacy organizations have been deeply engaged with the FDA over the past several years to develop PFDD tools that produce scientifically valid patient experience information. Tremendous progress has been made over the past decade since the fifth Prescription Drug User Fee Act (PDUFA) was authorized, including with PFIA and other provisions of 21st Century Cures. Now is the time to take the next step in moving patient perspectives and experience forward by enacting the BENEFIT Act.
The BENEFIT Act would require FDA to include in the benefit-risk assessment framework of a new drug application how patient experience data was considered in the review process. Currently, FDA includes patient experience data in reviews, but does not indicate how such data impacted the drug approval. Providing this information to the public, and patient communities making significant investments in developing PFDD, builds on transparency from PFIA and will accelerate PFDD strategies more broadly.
The field of patient engagement in drug development continues to flourish thanks to the continued interest and focus by Congress. The BENEFIT Act will build upon this foundation and fill a gap by appropriately disclosing how this data is considered as part of FDA review of new therapies.
PPMD is grateful to the 50+ organizations that signed onto a letter in support of the BENEFIT Act.