US FDA Benefit-Risk Assessment Plan viewed by PhRMA

US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) says it shares the Food and Drug Administration’s belief that a structured approach to benefit-risk assessment can improve and facilitate greater understanding of FDA’s regulatory decisions by public stakeholders including patients, consumers, health care professionals and biopharmaceutical companies.

The comment was made in reaction to the publication of the FDA’s Draft Prescription Drug User Fee Act (PDUFA) V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making

“A fully integrated use of the structured framework within FDA’s regulatory review can advance the Agency’s efforts to achieve greater consistency in the regulatory review and decision-making process while supporting systematic consideration of the patient perspective,” said PhARMA’s vice president of scientific and regulatory affairs, Sascha Haverfield.