Re: Docket No. FDA–2013–N–020: Center for Drug Evaluation and Research Medical Policy Council; Request for Comments
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research Medical Policy Council; Request for Comments.” BIO commends the FDA for reaching out to the public and regulated industry to seek input on topics for discussion by the Medical Policy Council. In light of the rapid pace of biomedical advancement and the complexity of modern drug and biologic development, it is important for FDA to systematically assess existing policies, develop new regulatory approaches, and ensure consistent and predictable implementation of medical policies across various FDA offices and review divisions.
The CDER Medical Policy Council serves a positive function in this process as a forum for senior management input into novel medical policy issues to promote the most efficient and effective methods for demonstrating the safety and efficacy of new therapies. We welcome additional clarity regarding the upcoming agenda topics and objectives for Medical Policy Council consideration.
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
BIO is please to suggest for condieration by the FDA Medical Policy Council the following topic areas: pathways for expedited drug development; standards for qualification of biomarkers and other durg development tools; regulation of tests for precision medicine; acceptable clinical trial approaches for disease subsets; post marketing requirment and post marketing commitment tracking; standard for imposing, and removing, safey study requirements; proprietary name review; and output of the medical policy council deliberations.