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BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions

Human Health • Letters, Testimony & Comments • December 17, 2019

On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions. BIO appreciated FDA’s effort to evaluate this 2010 guidance to ensure it remains useful and up to date. BIO's members have found this guidance very useful but acknowledge that certain portions should be updated to reflect current law, regulation and FDA practice. BIO requested that the guidance be revised to reflect FDA’s current thinking and practice to better describe FDA’s expectations with respect to use of IVDs in drug trials and companion diagnostic co-development. BIO is the world's largest trade association representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. Specifically, many of BIO’s members develop, market, or are impacted by diagnostic technologies for a variety of research, investigational, and clinical uses. BIO’s members also develop therapeutic products that are guided by diagnostics tests that provide the right treatment for the right patient at the right time—the essence of the modern precision medicine paradigm.

Human Health • Letters, Testimony & Comments • December 17, 2019

On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer. BIO is the world's largest trade association representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. Specifically, many of BIO’s members develop, market, or are impacted by diagnostic technologies for a variety of research, investigational, and clinical uses. BIO’s members also develop therapeutic products that are guided by diagnostics tests that provide the right treatment for the right patient at the right time—the essence of the modern precision medicine paradigm. Diagnostic technologies, such as next generation sequencing (NGS) testing for cancer diagnosis and treatment, play a pivotal role in personalized medicine, allowing an individual’s genetic profile to guide decisions regarding prevention and treatment of serious health conditions. The availability of high-quality molecular profiling advances access to the most appropriate course of therapy in a more expeditious and efficient manner. Providing coverage for technologies and tools that advance patient access to the most appropriate course of treatment helps to improve health outcomes and reduce overall healthcare spending in the short- and long-term. We are appreciative of the revisions proposed by the Agency in this Proposed Decision Memorandum, which signify CMS’ recognition that germline mutations may inform treatment options and cancer risk for patients. BIO supports CMS…

Agriculture & Environment, Food & Farm Innovation • Press Release • December 17, 2019

Washington, D.C. (December 17, 2019) – A rider to the FY2020 Agriculture Appropriations Bill will direct the bioengineered AquAdvantage salmon to carry additional labeling to distinguish it from conventionally raised Atlantic salmon. This could be in addition to the existing requirement provided by the National Bioengineered Food Disclosure Standard. The following statement can be attributed to BIO president & CEO Jim Greenwood: “While this provision allows AquAdvantage salmon to finally enter the U.S. marketplace, it’s disappointing that this action calls for a duplicative disclosure mechanism that will only serve to confuse consumers. “Congress passed the bipartisan Bioengineered Food Disclosure Act in 2016, and USDA issued a final rule in December 2018 aimed at providing consumers with information about their food in a consistent and truthful way. Bioengineered salmon are already explicitly covered by USDA’s rule without this unnecessary provision. “This also sets a negative precedent for suppressing future innovations that have the potential to improve our food, our health and our planet by providing a template for politicians to impede the commercialization of any new product if it serves their political agenda. “If Congress allows their own policies to be undermined, predictability in the system will suffer as will investment, innovation, and small business success.” The AquAdvantage Salmon was developed by Massachusetts-based AquaBounty Technologies, a BIO member. It is genetically engineered to reach its market weight in half the time of conventionally raised salmon while using 25 percent less food, thus contributing to more sustainable aquaculture systems.

Human Health • Press Release • December 12, 2019

Former Congressman Jim Greenwood, President and CEO of the Biotechnology Innovation Organization (BIO), issued the following statement after the U.S. Senate confirmed Dr. Stephen Hahn to serve as the next commissioner of the Food and Drug Administration: “The Food and Drug Administration plays a critical role in helping to ensure patients and consumers have access to the innovative medicines our scientists and researchers discover, as well as to the next wave of food-related biotechnology innovation. We congratulate Dr. Hahn on his confirmation, and we look forward to working with him and the entire FDA team to ensure the American people continue to benefit from the power and promise of biotechnology.” ###

Human Health, Reimbursement & Access, Cost & Value of Biopharmaceuticals • Press Release • December 12, 2019

Trump Administration and Speaker Pelosi Surrender Powerful Tool for Reining in Foreign Free Riding

Human Health, Cost & Value of Biopharmaceuticals • Press Release • December 10, 2019

Exclusion of biologics provisions in revised USMCA sets dangerous precedent for future trade talks, including with China Puts American jobs, intellectual property and leadership in medical innovation at risk WASHINGTON – BIO President and CEO Jim Greenwood released the following statement in response to a renegotiated USMCA that excludes provisions that prohibit foreign countries and foreign companies from stealing American medical innovation: “President Trump has promised to end foreign free-riding on American medical innovation, but by removing enhanced IP protections for biologic medicines, his administration just surrendered one of the most important tools that would help stop it. “The Administration and Speaker Pelosi have missed a critical opportunity to raise intellectual property standards in key markets, create good American jobs and ensure that American biopharmaceutical companies have their ingenuity, innovation and hard work protected around the globe. They have forsaken a sector in which America leads the world, and which promises to be a key sector of our 21st century economy. “Small U.S. biotechnology companies depend on their government to protect them in global markets and to ensure a level playing field. “Today’s announcement declares open season on these innovators and sends a clear message that the U.S. government will stand idly by while foreign entities attack American intellectual property, American jobs and America’s global leadership in medical innovation. “Foreign countries, including China, looking at this agreement will know that the U.S. government is not prepared to protect American innovation in the biopharmaceutical sector and that it can be pirated with impunity. “The real losers today are America’s scientists, entrepreneurs and patients waiting for the next generation of breakthrough medicines.” ###

Human Health, Reimbursement & Access, Cost & Value of Biopharmaceuticals • Press Release • December 5, 2019

More than 135 Emerging Biotech Leaders Urge Congress to Reject H.R. 3 “Our continued success depends on maintaining an environment that supports investment in tomorrow’s discoveries.” Washington, DC: December 5, 2019 – In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to benefit from the extraordinary science happening in labs across America. As the biotech leaders write: “We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs. … “Unfortunately, H.R. 3 is an unprecedented and aggressive government intervention in the U.S. market of drug development and delivery that will limit patient access to these extraordinary advancements in health care. “This extreme proposal will upend the ecosystem of U.S. biomedical innovation, destroying our ability to attract private investment dollars that allow us to develop new treatments and change the course of healthcare delivery for so many patients.” For a better approach, policymakers should consider solutions that lower what people pay for life-saving medicines and ensure all patients can get the cures and treatments they need. As the group concludes: “We strongly urge you to abandon H.R. 3. Further, in order to keep pace with this biomedical revolution and ensure America remains the world leader in innovation, we hope that you will pursue bipartisan, holistic policies that modernize our health care payment system and lower drug costs for patients.” To learn more about H.R. 3, click here.

Letters, Testimony & Comments • December 5, 2019

In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to benefit from the extraordinary science happening in labs across America. “We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs. … “Unfortunately, H.R. 3 is an unprecedented and aggressive government intervention in the U.S. market of drug development and delivery that will limit patient access to these extraordinary advancements in health care."

In the Fall of 2018, the Treasury Department announced the launch of a pilot program implementing certain provisions of the Foreign Investment Risk Review Modernization Act (FIRRMA). FIRRMA made several reforms to the procedures of the Committee on Foreign Investment in the U.S. (CFIUS), the interagency committee tasked with reviewing transactions with foreign investors that may pose national security risks. Under FIRRMA, CFIUS has expanded authorities to review and potentially block non-U.S. investments in U.S. businesses (and real estate) if it finds that the deal would impair U.S. national security. Please review the links below to gain a better understanding of how FIRRMA and CFIUS may impact the biotechnology sector and your company.