Letters, Testimony & Comments

June 23, 2011
BIO’s testimony details how the growth of agricultural biotechnology has provided numerous benefits to farmers, consumers and the environment, and highlights the potential for agricultural biotechnology to meet future demands and global...
June 15, 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...
June 14, 2011
Dear Chairman Smith: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager's Amendment to H.R. 1249, the America Invents Act. It is our strong desire to see this bill, as...
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...
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...
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...
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...
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...
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...
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 The Draft Guidance acknowledges there would be considerable efficiencies if MedGuides were...
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...
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/...
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...
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...
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...
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...
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...
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...
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...