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BIO Comments on Draft Guidance for Industry on New Chemical Entity Determinations for Certain Fixed-Combination Drug Products

Apr 24 2014
BIO supports FDA’s proposed revised interpretation in the Draft Guidance of the term “drug” in the eligibility clause of the New Chemical Entity (NCE) exclusivity statutory provisions. ” FDA’s revised interpretation, as expressed in the Draft Guidance, is a permissible reinterpretation, and when implemented, will positively impact public health, by encouraging innovation in fixed dose combination drugs. In order to both benefit public health as well as to ensure fair and consistent treatment of fixed dose combination product exclusivity determinations going forward, BIO urges FDA to finalize and implement this new interpretation expeditiously.

BIO Submits Comments to FDA on Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs

Apr 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Request for Information (RFI) on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.”

BIO Submits Comments to IOM Committee of Strategies for Responsible Sharing of Clinical Trial Data

Apr 13 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise. 

Social Media: BIO Comments on FDA Draft Guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

Apr 13 2014
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the FDA Draft Guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (Draft Guidance).   BIO represents more than 1,000 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, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

BIO Signs Group Letter Expressing Concern Over Patent Legislation

Apr 2 2014
BIO joins coalition letter to Chairman Patrick Leahy and Ranking Member Chuck Grassley expressing serious concerns with the direction of patent legislation.

BIO Submits Comments to the Centers for Medicare and Medicaid Services (CMS) Regarding the Center for Medicare and Medicaid Innovation's (CMMI's) Affordable Exchanges Guidance: Letter to Issuers on Federally-facilitated and State Partnership Exchanges

Mar 28 2014
March 15, 2013   Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   Re: Affordable Exchanges Guidance: Letter to Issuers on Federally-facilitated and State Partnership Exchanges   Dear Ms. Tavenner:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft Letter related to the Patient Protection and Affordable Care Act’s (PPACA) health insurance Exchanges that the Centers for Medicare & Medicaid Services (CMS) issued on March 1, 2013, entitled “Letter to Issuers on Federally-facilitated and State Partnership Exchanges” (the “Letter”).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's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first case. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations and surgical interventions.

BIO Submits Comments to the Centers for Medicare and Medicaid Services (CMS) Regarding the Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces

Mar 27 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   Re: Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces   Dear Ms. Tavenner:             The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft letter related to the Patient Protection and Affordable Care Act’s (ACA) health insurance Marketplaces that the Centers for Medicare & Medicaid Services (CMS) issued on February 4, 2014, entitled “Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces” (the “Draft Letter”).[1]             BIO represents more than 1,000 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 patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare & Medicaid Services (CMS), Draft 2015 Letter to Issuers in the Federally-facilitated Marketplaces (FFM) (Feb. 4, 2014). Available at: http://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/draft-issuer-letter-2-4-2014.pdf (hereinafter “Draft Letter to Issuers”).   

BIO Submits Comments to the Centers for Medicare and Medicaid Services (CMS) Regarding the Center for Medicare and Medicaid Innovation's (CMMI's) Request for Information: Evolution of ACO Initiatives at CMS

Mar 27 2014
VIA ELECTRONIC SUBMISSION   March 1, 2014     Patrick Conway, M.D. Deputy Administrator for Innovation and Quality Chief Medical Officer Centers for Medicare & Medicaid Services Center for Medicare and Medicaid Innovation 7500 Security Boulevard Baltimore, MD 21244   RE: Request for Information: Evolution of ACO Initiatives at CMS   Dear Dr. Conway:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Request for Information (RFI) on the “Evolution of ACO Initiatives at CMS” released by the Center for Medicare and Medicaid Innovation (CMMI) on December 20, 2013.[1]  BIO represents more than 1,000 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 patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place.  In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1]           Center for Medicare and Medicaid Innovation, Request for Information: Evolution of ACO Initiatives at CMS (Dec. 20, 2013), available at: http://innovation.cms.gov/Files/x/Pioneer-RFI.pdf.   

Biofuel Trades Letter to Senate Finance Re Extension of Expired Advanced Biofuels Tax Credit

Mar 25 2014
RE: Extension of Expired Advanced Biofuels Tax Credits   Dear Chairman Wyden and Ranking Member Hatch:   As the Senate Finance Committee begins its work on tax extenders, we encourage you to extend the suite of critical advanced biofuels tax incentives – the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel and Alternative Fuel Mixture Excise Tax Credit.

Drug Labeling: BIO Comments on CBE-0 Proposed Rule

Mar 14 2014