Press Release

PhRMA Statement on FDA Benefit Risk Assessment Plan

PhRMA May 9, 2013

WASHINGTON, D.C. (May 9, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, Ph.D., issued the following statement today on the Food and Drug Administration’s (FDA) Draft PDUFA V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making:

“PhRMA shares FDA’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, healthcare professionals and biopharmaceutical companies.

“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.   

“The benefit-risk framework should be used to facilitate and improve the quality of interactions between sponsors and FDA during the drug development and review process.We encourage the FDA to think about ways to use the benefit-risk framework to facilitate discussions with sponsors at mid-cycle and late-cycle meetings in order to facilitate a more efficient, high quality review of new medicines. A structured approach to benefit-risk assessment could also be helpful to facilitate discussion at Advisory Committee meetings.

“PhRMA supports FDA’s efforts to advance patient-focused drug development, and looks forward to learning how the Agency will incorporate patient perspectives into regulatory decision-making, particularly the process for integrating any differences in perspective (between the regulator, patient, caregiver, etc.) in the final benefit-risk assessment.

“While PhRMA believes that the principles of FDA’s approach to benefit-risk are generally aligned with other global initiatives, we encourage the Agency’s continued dialogue with other regulatory agencies on methodologies of assessing benefit-risk to advance global convergence of approaches that are necessary for the development of new medicines for the world’s patients.

PhRMA looks forward to continuing to work with FDA and other stakeholders on the implementation of this effort.”

PhRMA’s comments are available at

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.

Find PhRMA Online:

For information on how innovative medicines save lives, visit:

For information on the Partnership for Prescription Assistance, visit:

For information on ensuring the flow of medicines during public health emergencies, visit