Thanks to biotechnology, advances in biofuels made from renewable resources and waste feedstocks can be used to decarbonize our roadways, seaways, and airways. In order to achieve the goal of a 100 Percent Clean Economy for this segment of the transportation sector, stable and supportive policy is critical to drive investment and consumption of sustainable biofuels.  We have already seen the environmental benefits biofuels have provided in decarbonizing light-duty vehicles (LDV). The development and advancement of advanced biofuels will be essential to decarbonizing industries such as long-haul trucking, aviation, and marine shipping.

The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the world. The comments were recently highlighted by Tom DiLenge, president of BIO’s Advocacy, Law & Public Policy Division, during The White House Summit on America’s Bioeconomy, which included leaders from industry, academia, and the government. “It’s a remarkable time for the biotechnology industry in America. Our world-class scientists, brilliant researchers, and savvy entrepreneurs are making an enormous difference in improving the health of our loved ones and our planet,” DiLenge noted. “Yet while our progress has been amazing, the continued success and leadership of the American biotech industry is not guaranteed. We cannot abandon the policies that have made our bioeconomy the strongest and most dynamic in the world, and we must work to update our policies to meet the challenges posed by the next wave of biotechnological innovations.” Read the full comments via the link below.

Dear Administrator Verma:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to commenton the Center for Medicare and Medicaid Services’ (CMS’s) CY2020 Revisions to PaymentPolicies under the Physician Fee Schedule (PFS) and Other Changes to Part B PaymentPolicies (“Proposed Rule”).BIO is the world’s largest trade association representing biotechnology companies, academicinstitutions, state biotechnology centers and related organizations across the United Statesand in more than 30 other nations. BIO’s members develop medical products andtechnologies to treat patients afflicted with serious diseases, to delay the onset of thesediseases, or to prevent them in the first place. In that way, our members’ noveltherapeutics, vaccines, and diagnostics not only have improved health outcomes, but alsohave reduced healthcare expenditures due to fewer physician office visits, hospitalizations,and surgical interventions. BIO membership includes biologics and vaccine manufacturersand developers who have worked closely with stakeholders across the spectrum, includingthe public health and advocacy communities, to support policies that help ensure access toinnovative and life-saving medicines and vaccines for all individuals.We offer comments on the following areas in the proposed rule, with an emphasis onensuring that Medicare beneficiaries have access to the full range of items and servicesnecessary to their health:• BIO appreciates the opportunity to comment on the agency’s future consideration ofbundled payments under the PFS but urges CMS to prioritize patient access toappropriate therapies and to weigh the results of other demonstrations underwayrather than attempting to swiftly implement bundled payments.• BIO supports the proposal to retain more granular payments for Evaluation andManagement (E/M) services, which we think will support access to appropriate carefor the sickest patients.​

Dear Administrator Verma,The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment onthe Centers for Medicare & Medicaid Services’ (CMS’) Medicare Hospital OutpatientProspective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule.BIO is the world's largest trade association representing biotechnology companies, academicinstitutions, state biotechnology centers and related organizations across the United Statesand in more than 30 other nations. BIO’s members develop medical products andtechnologies to treat patients afflicted with serious diseases, to delay the onset of thesediseases, or to prevent them in the first place. In that way, our members’ noveltherapeutics, vaccines, and diagnostics not only have improved health outcomes, but alsohave reduced healthcare expenditures due to fewer physician office visits, hospitalizations,and surgical interventions. BIO membership includes biologics and vaccine manufacturersand developers who have worked closely with stakeholders across the spectrum, includingthe public health and advocacy communities, to support policies that help ensure access toinnovative and life-saving medicines and vaccines for all individuals.BIO represents an industry that is devoted to discovering new treatments and ensuringpatient access to them. Accordingly, we closely monitor changes to Medicare’sreimbursement rates and payment policies for their potential impact on innovation andpatient access to drugs and biologicals. Our comments on the Proposed Rule are outlinedbelow

September 30, 2019Re: Docket No. FDA–2014-D-1461: FDA Draft Guidance, Rare Pediatric Priority Review Vouchers.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments in response to the FDA’s Draft Guidance on Rare Pediatric Disease Priority Review Vouchers.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’s members develop medical products and technologies to treat people afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.BIO commends the Agency’s efforts to provide guidance on the implementation of Section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), the Rare Pediatric Disease Priority Review Voucher (RPD PRV) Program. The Rare Pediatric Disease Priority Review Voucher Program, along with other incentives, is essential for encouraging investment and research into development for therapies to treat pediatric patients with rare diseases.As FDA works to improve and streamline the implementation of the RPD PRV process, we recommend that the Agency consider a common application for Orphan Designation and the Rare Pediatric Diseases Designation and streamlining the process for transfer and use of the PRV. We believe that our recommendations not only provide clarity regarding some of the elements in the Draft Guidance but also serve to continue to incentivize the development of therapies for rare pediatric diseases, as intended by Congress.PRVs are earned or purchased by a sponsor to be redeemed, along with a PRV fee, for Priority Review of an application. As such, we recommend that a voucher and fee would only be needed in a circumstance where the application would not receive a Priority Review based on its own…