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BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012

May 30 2012

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BIO Testimony to House Agriculture Subcommittee on Farm Bill Energy Programs

May 21 2012
BIO is the world’s largest biotechnology organization, with more than 1,100 members worldwide.

BIO Comments on EPA SAB Draft Report: Biogenic Carbon Accounting

May 21 2012

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BIO Comments on Interagency Request for Information on Military Biofuels

May 21 2012
The Biotechnology Industry Organization (BIO) on behalf of its member companies commends the U.S. Navy, Department of Energy (DOE) and Agriculture (USDA) on their Memorandum of Understanding (MOU) designed to help develop advanced drop-in and marine biofuels to power military and commercial transportation.  We are pleased to provide this response to the joint request for information (RFI).

DDI: BIO Comments on FDA's Draft Guidance for Industry Drug Interaction Studies

May 20 2012

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340B Program: BIO Comments on Health Resources and Services Administration (HRSA) Notice on the Enrollment and Recertification of Entities in the 340B Pricing Program

May 17 2012

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BIO Comments on CMS Electronic Health Record Incentive Program

May 17 2012
  The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule specifying the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments.[1]  BIO represents more than 1,100 biotechnology 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 innovative healthcare, agricultural, industrial and environmental biotechnology products.  BIO membership includes both current and future vaccine developers and manufacturers who have worked closely with the public health community to support policies that help ensure access to vaccines for all individuals.  We support the use of appropriate, evidence-based objectives and quality measures throughout the healthcare system and we feel that immunizations have long been considered a proven and cost-effective healthcare intervention for persons of all ages. Comments  BIO supports CMS’ Medicare and Medicaid EHR Incentive Programs, which promote the adoption and meaningful use of certified EHR technology.  The meaningful use of EHR technology by healthcare providers and hospitals can have a positive impact on immunization rates in the United States by helping eliminate missed opportunities for vaccination as well as avoid over-immunization.  In turn, higher immunization rates lead to better health outcomes and cost savings for the healthcare system.  Our comments focus on CMS’ proposals regarding: (1) the core public health objectives for Stage 2; (2) clinical decision support interventions; and (3) clinical quality measures.  BIO also comments on the definition of EP.  Specifically, BIO supports and recommends the following:  BIO supports CMS’ proposal to make ongoing reporting to immunization registries a core public health objective for Stage 2. BIO recommends that at least one immunization clinical quality measure be included in the core set in Table 6 for EPs and that two additional measures be included in Table 8. BIO supports the inclusion of new immunization clinical quality measures in the menu set for eligible hospitals and CAHs. BIO supports the implementation of clinical decision support interventions that have a strong evidence base, such as clinical decision support interventions linked to immunization measures. BIO recommends that CMS request an expansion of the EP definition.  

CED: BIO Public Statement: Medicare Evidence Development & Coverage Advisory Committee Meeting, Evidentiary Characteristics for Coverage with Evidence Development (CED)

May 15 2012

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Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet

May 13 2012

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FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products

May 11 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products.