BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document.
The draft guidance provides recommendations to applicants on drafting proposed Risk Evaluation and Mitigation Strategy (REMS) documents and converting an already-approved REMS document to a new standardized format.
BIO provides suggestions for how to improve the guidance regarding REMS requirements for programs run or administered through specialty pharmacy healthcare settings. In addition, BIO asks the FDA to specify details on storage and retention of participant documents, monitoring of patients, and the duration of retention of participant materials.
BIO submitted comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA).
BIO is committed to promoting a regulatory environment that continues to support and incentivize the biopharmaceutical ecosystem. Minimizing the regulatory burden on the biopharmaceutical sector will foster small business growth, create good, high-paying jobs, directly and indirectly expand the economy, and expedite the development and delivery of safe and effective therapies to patients.
BIO developed a priority list of regulations and guidance documents that, if modified or eliminated, would significantly decrease regulatory costs, advance the fast and safe development and delivery of effective therapies, and drive investment in innovation by fostering an environment that recognizes the value these new medicines bring to patients and the overall healthcare system. These documents fall into three categories: Accelerating Products to Market & Reducing Pre-Market Regulatory Costs, Lowering Post-Market Regulatory Compliance Costs, and Removing Regulatory Barriers that Impede Value-Based Arrangements.
The Biotechnology Innovation Organization ("BIO") welcomes the opportunity to submit comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued on January 18, 2017 ("Draft Guidance").
Human Health, Opioids • Toolkit • December 1, 2017
The biopharmaceutical industry offers real solutions to the devastating opioid crisis. Emerging biotechnology companies and established enterprises are working hard to transform the standard of care for pain and addiction through novel and safer next generation therapies.
BIO is disappointed that EPA did not raise the Renewable Fuel Standard's advanced and cellulosic biofuel volumes for 2018 in line with the industry’s ability to produce them.
BIO submitted comments in response to the Department of Health and Human Services' Proposed Notice of Benefit and Payment Parameters for 2019. In its annual update of standards and requirements related to the exchanges and the health plans offered on them, HHS should strive for a policy framework that ensure access to health insurance also means access to appropriate care. We appreciate the work undertaken by HHS to develop and refine this framework since the inception of the Exchanges in 2014. But we believe more can and should be done. In this Notice, the Department proposes a number of modifications to foundational elements of the Exchanges – including significant changes to the ways States craft their essential health benefits (EHB) packages. We encourage the Department to carefully consider how these and other changes could impact the patient experience for those enrolled in health plans through the Exchanges.
BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.
Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments”To whom it may concern:The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its proposed Agricultural Biotechnology Education and Outreach Initiative (FDA-2017-N-5991).BIO is the world's largest biotechnology trade association, representing small and large 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 agricultural, healthcare, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to the uses of biology-based technologies in agriculture, animal health and human health.
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity.
The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of biological products licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)). BIO provides general comments and suggested changes.
