Richard M. Klein, Director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs, recently wrote at FDA Voice about the agency’s efforts in patient-focused drug development. Klein discussed the FDA’s Patient-Focused Drug Development initiative, a part of the FDA’s commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).
The FDA states: “In PDUFA V, FDA also committed to a new initiative called Patient-Focused Drug Development with the goal of obtaining the patient perspective on certain disease areas during the five year period of PDUFA V. Assessment of a product’s benefits and risks involves an analysis of the severity of the condition treated and the current treatment options available for the given disease. This information is a critical aspect of FDA’s decision-making as it establishes the context in which the regulatory decision is made.”
Klein writes that the FDA will hold at least 20 public meetings over the next 5 years, each focused on a different disease area. The information discussed will be summarized for consideration by the agency when making regulatory decisions in a therapeutic area.
The FDA’s first meeting was with chronic fatigue syndrome and myalgic encephalomyelitis patients on April 25, 2013. The second meeting, on June 14, 2013, discussed HIV-AIDS. At each meeting, the agency learned from patients about their current treatment options. The agency’s third meeting was on June 28, 2013 and focused on lung cancer. 13 additional disease areas have been selected for future meetings.