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Letters, Testimony & Comments

Fee Diversion: BIO Joins Broad Coalition to Support End of Fee Diversion at PTO
June 13, 2011
Dear Speaker Boehner and Leader Pelosi: We write to express our unified support for Section 22 of H.R. 1249, “The America Invents Act.” We heartily commend Judiciary Committee Chairman Smith, Ranking Democrat Conyers, Subcommittee...
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA)
June 9, 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments relating to the development of a user fee program for biosimilar and interchangeable biological...
BIO Submits Comments to FDA on "Biologics Price Competition and Innovation Act of 2009 (BPCIA); Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017"
June 9, 2011
BIO generally supports and agrees with FDA's statements that existing user fee programs can inform the Agency's development of a user fee program for 351(k) applications, and that the establishment of user fees for products subject to the...
BIO's Comments on the CMS Accountable Care Organizations Proposed Rule
June 6, 2011
Re: Medicare Program; Medicare Shared Saving Program: Accountable Care Organizations; Proposed Rule [CMS-1345-P] Dear Dr. Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for...
BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)
May 31, 2011
BIO provides specific comments and requests clarifications on the text of the Guideline regarding the variability of immunogenicity, approaches for predicting and reducing immunogenicity, clinical consequences of immunogenicity, problems with...
BIO Submits "Guideline on similar biological medicinal products containing monoclonal antibodies" Comments to the European Medicines Agency (EMA)
May 31, 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the "Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies." BIO...
BIO Submits Comments to FDA on "Draft Guidance for Industry on Medication Guides—Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies"
May 31, 2011
BIO commends the FDA for taking this step to distinguish MedGuides approved under the Part 208 regulations from MedGuides required subject to a REMS. The Draft Guidance acknowledges there would be considerable efficiencies if MedGuides were...
Driving Innovation and Job Growth Through the Life Sciences Industry
May 25, 2011
Good morning Chairman Casey, Vice Chairman Brady, Ranking Member DeMint, Ranking Member Hinchey, Members of the Committee, ladies, and gentlemen. I am President and Chief Executive Officer of Lexicon Pharmaceuticals, Inc. I am appearing before...
Driving Innovation and Job Growth Through the Life Sciences Industry
May 25, 2011
Representatives of the bioscience industry testified before the U.S. Congress Joint Economic Committee today, as part of a hearing entitled Driving Innovation and Job Growth through the Life Sciences Industry. Dr. Arthur Sands, president/CEO/...
BIO Requests for FY 2012 Energy and Water Appropriations Act
May 17, 2011
Dear Chairman Frelinghuysen and Ranking Member Visclosky: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage you to support advanced biofuels and biobased products programs and initiatives during consideration...
Biofuels: Congress Should Maintain Renewable Fuel Standard, BIO and Other Groups Urge (May 17, 2011)
May 17, 2011
Dear Chairman Upton, Chairman Boxer, Ranking Member Waxman, and Ranking Member Inhofe: As the leading advocates of the U.S. biofuels industry, we are committed to policies that will ensure low carbon, domestically-produced biofuels continue to...
BIO Urges Congress to Reauthorize Pendemic and All-Hazards Preparedness Act
May 17, 2011
TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) SENATE HELP COMMITTEE   May 17, 2011   Good morning Chairman Harkin, Ranking...
BIO Commends Department of Commerce for Promoting Robust Intellectual Property Standards and Policies Abroad
May 13, 2011
Dear Secretary Locke: On behalf of the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), we write to express our appreciation and support for your continued leadership in promoting...
BIO Requests for FY 2012 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act
May 12, 2011
Dear Chairman Kingston and Ranking Member Farr: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage your support of programs and initiatives of critical importance to our industry. Please support the following...
BIO Urges Congress to Reauthorize Pendemic and All-Hazards Preparedness Act
May 11, 2011
Testimony of Phyllis Arthur, Senior Director for Vacines, Immunotherapeutics and Diagnostoics Policy Senate HELP Committee Good morning Chairman Harkin, Ranking Member Enzi, Members of the Committee, ladies and gentleman. I am Phyllis...
Dr. Stephen Sherwin, BIO Chairman and Chairman & Co-founder of Ceregene, Addresses Attendees at BIO International Convention
May 5, 2011
Thank you, ladies and gentlemen. I would like to add my welcome to all of you to the BIO 2010 International Convention. It has really been my honor to serve as the Chair of BIO's Board of Directors - your Board of Directors - during the past...
BIO's Comments on the Internal Revenue Service's (IRS) Proposed Guidance Regarding the Branded Prescription Drug Fee
April 29, 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Internal Revenue Service (IRS) on the...
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA
April 28, 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the...
BIO's Comments on the Centers for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
April 28, 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and ongoing challenges related to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research...
Biofuels: BIO Opposes New Hampshire's Proposed Ethanol Ban
April 28, 2011
Committee on Transportation New Hampshire State Senate Hearing on HB 374, banning corn-based ethanol as an additive to gasoline sold in New Hampshire. Written Testimony Submitted by Biotechnology Industry Organization April 28, 2011 The...