Comments on Periodic Review of Existing Regulations; Retrospective Review under Executive Order 13563
Today, biotechnology companies have more than 600 new biologic medicines in development and biotechnology is behind about two-thirds of the new medicines in development. However, continued advancement in biotechnology and the life sciences requires an efficient and effective regulatory environment that supports innovation, keeps pace with modern science, and promotes the public health, while not impeding robust economic growth and job creation. BIO asks the Food and Drug Administration for the appropriate balance of benefit and risks, greater flexibility and discretion under the "substantial evidence" standard, clarification of the treatment of therapeutic biologics, evaluation of the regulatory burden of guidances, and economic impact and cost analysis. BIO also addresses issues in a more targeted manner for specific regulations.