The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.
PhRMA is a voluntary, non-profit association that 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. PhRMA members have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $51 billion in 2013 alone.
BIO represents more than 1,000 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.
PhRMA and BIO appreciate the opportunity to comment on this draft guidance and welcome the Agency’s efforts to clarify the process for implementing electronic submission requirements under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FDCA). In general, PhRMA and BIO agree with the FDA’s interpretation of Section 745A(a) of the FDCA, but note there are some areas that require clarification prior to finalization of and implementation of this binding guidance. These areas requiring further clarification include (1) the process FDA intends to use to communicate and implement specific electronic submission requirements, specifically related to revisions and updates to existing standards, and (2) the process for determining the timeline in which certain requirements will take effect.