BIO Submits Comments Re: Medicare CY 2019 Part D Proposed Rule

Jan 25 2018
BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most appropriate course of treatment. Our comments, detailed further in the balance of this letter, focus on the following areas: Request for Information to Require Pass through of Manufacturer Rebates at the Point of Sale to the Beneficiary Implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA) Treatment of Follow-On Biological Products as Generics for Non-LIS Catastrophic and LIS Cost-Sharing Revisions to Part D Tiering Exceptions Expedited Substitutions of Certain Generics and Other Midyear Formulary Changes Maximum Out-of-Pocket Limit and Cost-Sharing Limits for Medicare Parts A and B Services Flexibility in the Medicare Advantage Uniformity Requirements Any Willing Pharmacy Standards Terms and Conditions Medicare Advantage and Part D Prescription Drug Program Quality Rating System MA/Part D Artificial Limits

REMS: BIO Comments on Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document

Dec 12 2017
December 11th, 2017 ...

BIO Submits Comments Re: ICER Proposed Revisions to its Value Framework for Treatments for Ultra-Rare Diseases

Dec 11 2017
BIO appreciates the opportunity to comment on these proposed revisions. Patients living with rare diseases often experience significant unmet medical need due to the lack of knowledge about how these diseases are caused or inherited and their progression. That those suffering from rare diseases are predominately children raises issues around how society prioritizes and develops treatments for these conditions. We believe there are significant challenges in reconciling existing population-level value assessment methodologies with the varied healthcare contexts and deeply personal patient-level treatment decisions faced by patients afflicted with rare diseases, their families, and their clinicians. For a number of reasons, applying a patient-centric lens when considering the value of treatment is especially important when considering rare diseases.

BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration

Dec 8 2017
December 7, 2017 ...

BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"

Dec 5 2017
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").  

BIO Comments: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access

Dec 5 2017
Bio Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (Docket No. FDA-2017-N-3615)

BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2019

Nov 29 2017
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.

Biomilars: BIO Comments on FDA Draft Guidance Statistical Approaches to Evaluate Analytical Similarity

Nov 28 2017
Re: Docket No. FDA-2017-D-5525: Statistical Approaches to Evaluate Analytical Similarity ...

BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information

Nov 27 2017
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.

BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)

Nov 21 2017
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.