PPMD Calls for Greater Transparency and Accountability of FDA Patient Engagement Efforts

Parent Project Muscular Dystrophy (PPMD) is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process during a Congressional briefing tomorrow, Tuesday, December 9th at noon. A champion of policies to enhance the voice of the patient within vital Food and Drug Administration (FDA) deliberations, PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools. PPMD and other stakeholders will be presenting on the reform proposal during the briefing tomorrow afternoon. Reform Proposals for 21st Century Cures Initiative We have seen significant progress over the years in how the FDA pays attention to the voice of the patient. PPMD has been focused relentlessly on this issue and has produced several groundbreaking tools intended to achieve this goal. Now, we must know that this work is bearing fruit and that FDA will actually be using these new tools as they review therapies for Duchenne and beyond. Dubbed the Patient-Impact Assessment Act, PPMD would like to see a simple and publicly accessible measurement tool developed whereby FDA reviews could note how they did or did not take various patient-focused drug development tools and resources into account in evaluating products and making their decisions. Such an assessment tool would shed light into how Patient Focused Drug...
Source: Parent Project Muscular Dystrophy - Category: Neurology Source Type: news