Re: Draft Guidance for Industry: Implementation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Docket No. FDA-2015-D-4750 (March 14, 2016))   The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) draft guidance entitled “Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009” issued on March 14, 2016 (“Draft Guidance”).   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, 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.   Implementation of the Biologics Price Competition and Innovation Act (“BPCIA”) is of significant importance to BIO members, and we greatly appreciate FDA’s efforts to provide clarity on the agency’s current thinking on the transition provisions. As detailed below, we do have concerns about the agency’s proposed interpretations of the provisions as outlined in this Draft Guidance. In finalizing the Draft Guidance, we strongly urge the agency to consider our comments and requested changes.

BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient Quality Reporting Program, the PPS-Exempt Cancer Hospital Quality Reporting Program, and the Long-Term Care Hospital Quality Reporting Program.

Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.