Call and email your Senators today! The Food and Drug Administration’s efforts to support meaningful patient engagement, also known as Patient-Focused Drug Development (PFDD), includes 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. Examples of PFDD tools include draft guidance documents submitted to FDA for their review and issuance, surveys of patients or primary caregivers on their benefit/risk preferences, patient-reported outcomes tools, and patient and caregiver preference and related data.
PPMD has been encouraging Congress and the FDA to take additional actions to encourage more patient groups to develop such tools to strengthen the voice of the patient in the review process. But we need to know how FDA reviewers are or are not using such instruments during the critical product review stage.
To address this issue, Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN) have introduced S. 1597, the Patient-Focused Impact Assessment Act. This bipartisan bill calls for FDA to develop a simple and publicly accessible checklist to show how reviewers are or are not using such PFDD tools like benefit/risk surveys, guidance documents and patient-reported outcomes when reviewing applications. The bill also calls for additional FDA clarity on actions patients and industry can take to develop PFDD products to drive further innovation in the field.
S. 1597 is cosponsored by Senators Susan Collins (R-ME), Michael Bennet (D-CO), Johnny Isakson (R-GA) and Al Franken (D-MN). We need you to call and email your Senators today and urge that they sign on as a cosponsor of S. 1597 before they go on recess on August 8th.