FDA: Enhancing Benefit-Risk Assessment in Regulatory Decision Making

Last summer, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).  Title I of FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides FDA with the necessary user fee resources to maintain an efficient review process for human drug and biologic products.  The reauthorization of PDUFA includes performance goals and procedures that represent FDA’s commitments during FY 2013-2017.  These commitments are referred to in section 101 of FDASIA. Section X of these commitments relates to enhancing benefit-risk assessment in regulatory decision-making.  A key part of regulatory decision-making is establishing the context in which the particular decision is made.  For purposes of drug marketing approval, this includes an understanding of the severity of the treated condition and the adequacy of the available therapies.  Patients who live with a disease have a direct stake in the outcome of FDA's decisions and are in a unique position to contribute to the understanding of their disease. FDA has committed to obtain the patient perspective on 20 disease areas during the course of PDUFA V.  For each disease area, the Agency will conduct a public meeting to discuss The disease and its impact on patients' daily lives, The types of treatment benefit that matter most to patients, and Patients' perspectives on the adequacy of available ...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs