Re: Docket No. FDA-2016-N-0001: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices” 

On behalf of the Biotechnology Innovation Organization (BIO), I am writing to offer our strong support H.R. 34, the 21st Century Cures Act, and urge the Senate to pass this important legislation.

Ten members the U.S. House of Representatives from New York wrote to U.S. Patent and Trademark Office Director Michelle K. Lee to express concern with continued abuse of the inter partes review (IPR) system by financial speculators and other third parties with no legitimate interests in the patented technology

Re: Docket No. FDA–2016–N–2673: Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding FDA’s Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA). BIO is the world's largest trade association representing 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.BIO is an active member of the Pharmaceutical Distribution Security Alliance (PDSA) and would like to reinforce and echo the positions put forth during their presentation at the public meeting and their additional written docket submission. As with our preparation for the 2015 interoperable exchange of information requirements, BIO members are working hard to prepare for the 2017 serialization requirements; however, we note that readiness across the supply chain to meet these requirements may vary. Based on our experiences with the 2015 requirements, we note that while FDA guidance is often helpful, it is extremely important for this guidance to also be timely. If guidance is released close to the statutory requirement deadlines, individual companies and their trading partners will have instituted procedures and policies to meet the requirements that could be badly affected if the published guidance is not consistent with what has been planned or implemented. To this end, BIO notes that guidance on grandfathering, exceptions, exemptions, and waivers has not yet been released. PDSA understands that any product packaged by a manufacturer…

Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.