title: Value Assessment in the Regulatory Context.
abstract: Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment.
authors.affiliation: Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: Kathleen.miller@fda.hhs.gov.
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Miller
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D003657:Decision Making; D017277:Drug Approval; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration; D062505:Value-Based Purchasing
keywords: FDA; pharmaceuticals; regulation; value assessment