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BIO Comments on Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

Oct 12 2018

October 12, 2018

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BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.

Oct 9 2018

October 8, 2018

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BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

Oct 2 2018
On September 24, BIO submitted final comments in response to the CY 2019 Outpatient Prospective Payment System Proposed Rule. This year’s OPPS rule included a Request for Information (RFI) around the potential development of a new innovation model for delivery of Part B drugs, using CMS’ authority under the previously existing Competitive Acquisition Program (CAP) – of which the original iteration was discontinued in 2008 after failing to attract participants and costing more than the traditional reimbursement structure in Part B. BIO outlined the need for CMS to be thoughtful and measured in the development of models that are voluntary and support a competitive, market-driven approach, including that any models properly address: (1) adequate protections for patient access to clinically appropriate care and lowering costs to beneficiaries; (2) not creating interference that erodes the existing coverage and reimbursement structure, (3) encouraging robust competition and avoiding misaligned incentives; (4) ensuring workability for physicians who may choose to participate; (5) considering appropriate exemptions for certain drugs and biologicals; and (6) transparency in model design, development, and assessment processes.

RDOD: FDA Draft Guidance Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

Sep 27 2018

September 25, 2018

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Biosimilars: Facilitating Competition and Innovation in the Biological Products Marketplace

Sep 27 2018

September 21, 2018

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BIO/Food Value Chain letter to Senate and House Appropriations Committee leadership in support of legislative language ensuring consistency under the National Bioengineered Food Disclosure Law

Sep 27 2018

September 21, 2018

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BIO/Coalition for Safe, Affordable Food letter for Senate and House Ag Committee leadership in support of biotech education provision

Sep 20 2018
Dear Chairman Roberts, Chairman Conaway, Ranking Member Stabenow, and Ranking Member Peterson: As representatives of the U.S. food and agricultural value chain and members of the Coalition for Safe, Affordable Food (the Coalition), we write to express our support for Section 7608 in the House-passed H.R. 2, the Agriculture Improvement Act of 2018, regarding public education on agricultural biotechnology. We believe these provisions will support the U.S. Department of Agriculture (USDA) and other relevant federal agencies in providing consumers with education materials on the National Bioengineered Food Disclosure Law (NBFDL) and its implementing regulations – the National Bioengineered Food Disclosure Standard (NBFDS). Such education materials can assist in explaining how the NBFDS provides consumers with information on the ingredients of the foods they eat, one overriding purpose of the NBFDL...

Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format

Sep 14 2018
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.

BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

Sep 14 2018
BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biologicals. As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Sep 11 2018

September 11, 2018

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