Read more about the Patient-Focused Impact Assessment below:
1597: The Patient-Focused Impact Assessment Act
The Food and Drug Administration Safety and Innovation Act (FDASIA) and its related user fee agreement contained a number of provisions intended to strengthen the meaningful engagement of the patient and other critical voices within the medical product review process. These provisions included the strengthening of existing tools and creation of new ones needed to fill gaps, policies to allow for greater engagement of external experts in the review process and a requirement for FDA to engage in multiple stakeholder meetings on the important issue of benefit/risk assessments. While patient stakeholders strongly supported these reforms, concerns exist as to how these new tools are being used by the FDA.
Need for Greater Accountability & Transparency
To address these concerns and ensure that the FDA uses existing and future patient-focused drug development tools and authorities to the greatest extent possible, Congress should enact additional reforms through the 21st Century Cures Initiative focused on achieving this goal. The reforms should recognize the progress of recent years, including the high levels of enthusiasm and innovation among the patient stakeholder community to play a more active role in the product review process. The Patient- Focused Impact Act is bipartisan legislation sponsored by Sen. Roger Wicker and Sen. Amy Klobuchar to do just that through two provisions:
- Development of the Patient-Focused Impact Assessment: Many stakeholders are questioning exactly how the FDA using PFDD tools and authorities when it comes to making critical decisions on whether or not to approve a product. To address this concern, the PFIA will require the development of a patient engagement assessment tool whose results would be included within the publicly disclosed safety and effectiveness data package of any approved drug. The assessment will be a simple and straightforward survey that asks reviewers how a number of PFDD tools and authorities informed their decision on a new drug application. Topics would include benefit/risk data for the indicated populations, draft or final guidances, patient-preference data, patient-reported outcomes data, and the views of patients and other external experts on the application. The assessment would shed light into how PFDD tools and authorities are or are not being used and would help identify gaps or shortcomings in the space.
- Issuance of Draft & Final Guidance to Patients and Industry on PFDD: This provision recognizes the immense potential possible through greater use of PFDD tools as well as the need for greater clarity and guidance from the FDA to both patient organizations and industry sponsors. It will require the FDA to issue draft and final guidance with the final guidance informed by a public comment period. The guidance would seek to encourage patient and industry collaborations on the development of PFDD tools.
Cosponsor S. 1597
The Patient-Focused Impact Act builds upon the success in recent years to strengthen the patient voice in the medical product development process. It would enact two targeted reforms to provide greater clarity and transparency to all stakeholders and help demonstrate how the FDA is using these tools and authorities.
To cosponsor S. 1597, please contact Sarah Lloyd Allred with Sen. Wicker at 4-6253 or Sarah Smith with Sen. Klobuchar at 4-3244 today!