Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid therapies can be surmounted through further innovation on safe and effective analgesics with lower risks.

The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).

In a recent letter, BIO applauded the Securities and Exchange Commission (SEC) for taking a proactive approach in amending its accelerated and large accelerated filer definitions. “If adopted as proposed, these amendments will benefit startups and their investors by freeing up more capital to invest in hiring scientists and pursuing research and development. Our members strive to protect investors by keeping them informed, but the overwhelming success of the JOBS Act shows that there is little investor sentiment for a costly one-size-fits-all compliance requirement, and they are instead more concerned with our ability to attract talent and innovate.”

In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk. “For many small, innovative companies, the Medicare Part D redesign policy passed by the Senate Finance committee in July represents a highly concerning shift in liability to those companies investing in the medical areas of highest unmet need. Specifically, the 20% manufacturer liability in the catastrophic phase of the restructured benefit could have a chilling effect on the innovation of specialty medicines and runs contrary to the many actions that Congress has taken to incentivize the development of breakthrough therapies. In short, patients still waiting for therapies and cures may find themselves unnecessarily waiting far longer, if not indefinitely,” the letter states. Read the full letter below.

October 30, 2019 Docket ID: No. EPA-HQ-OAR-2019-0136 Public Hearing: Renewable Fuel Standard Program: Standards for 2020 and Biomass Based Diesel Volume for 2021, and Response to the Remand of the 2016 Standards; Supplemental Notice of Proposed Rulemaking Comments: Good morning. I am Dr. Stephen Rapundalo, President and CEO of the Michigan Bioscience Industry Association or MichBio for short. In addition to MichBio I am appearing on behalf of the Biotechnology Innovation Organization (BIO). 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 represents companies across the entire value chain of biofuel production who are using industrial biotechnology to develop new energy crops, conversion technologies for these new feedstocks, improved conventional biofuel processes, and further advanced and cellulosic biofuel production technologies. Due to the time constraints today, I will provide a short statement on BIO’s behalf, regarding the U.S. Environmental Protection Agency’s (EPA) a supplemental notice of proposed rulemaking to the 2020 Renewable Fuel Standard (RFS) volumes, but BIO will provide a detailed response to the proposed rule in its written comments that it will submit next month. The Renewable Fuel Standard or RFS has been vital to BIO’s member companies, spurring investment and development of advanced and cellulosic biofuels. Unfortunately, the demand destruction caused by the drastic expansion of small refinery exemption waivers or SREs has had a major impact on the industry, costing jobs, stifling investment in innovation, and undermining efforts to reduce greenhouse gas emissions in the transportation sector. As a result, companies who have researched and developed technologies in the United States are looking to commercialize advanced and cellulosic biofuel technologies in…

Dear Chairman Tonko, Chairman Pallone, Ranking Member Shimkus, Ranking Member Walden, and Members of the Subcommittee: The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing, "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers." Executive Summary BIO applauds the Subcommittee for holding today’s hearing examining the impact the Administration’s expanded use of small refinery exemption (SRE) waivers has had on the advanced and cellulosic biofuels industry. The Renewable Fuel Standard (RFS) has been a vital tool to BIO’s member companies who are leading the development of advanced and cellulosic biofuels. As a market driver providing access to the transportation fuel market, the RFS has spurred research and investment in the development of low-carbon biofuels. The RFS has enabled the United States to become a leader in the development and deployment of new technologies which has led to the growth of the biobased economy, benefitting farmers and commodity producers, helping revitalize rural economies, creating good paying jobs, and fostering energy independence. Unfortunately, the U.S. Environmental Protection Agency’s (EPA) administration of the program has put the investments made by these companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the RFS intended. This undermines the future economic, environmental, and national security benefits the RFS provides. Introduction 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, and industrial and environmental…

In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive compensation, financial, and other disclosure requirements for an additional five years. “As helpful as this five-year exemption is, the biotech development timeline takes a decade or more. Emerging biotechs companies working on innovative therapeutics are highly dependent on access to capital during this time. Developing a single therapy requires an average investment of more than $2 billion. During this development stage, companies do not have a product to generate revenue and are dependent on capital markets to fund clinical trials. Every dollar spent on regulatory burdens that do not provide useful information to investors is therefore a dollar diverted from the lab. A five-year extension of EGC provisions will enable small public biotechs to continue to prioritize research and innovation, and will free up more capital to hire scientific and technical talent, invest further in R&D and clinical development, and enhance their ability deliver product candidates to patients suffering from various diseases,” Greenwood wrote. To read the full letter below.