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Letters, Testimony & Comments

Medicaid: BIO's Comments on CMS's Draft NARP Methodology
August 16, 2012
Dear Mr. Reed: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Draft Methodology for Estimating National Average Retail Prices (NARP) for Medicaid Covered Outpatient Drugs, commissioned from Myers...
US-EU Working Group on Jobs and Growth: BIO Submits Comments on IP
August 16, 2012
The Biotechnology Industry Organization (BIO) appreciates the U.S. Trade Representative's (USTR) query about BIO's views on how intellectual property should be treated in any future agreement arising from the U.S.- EU High Level Dialogue....
BIO Comments to CMS on Physician Payments Sunshine Act
August 14, 2012
Marilyn Tavenner Acting CMS Administrator Centers for Medicare and Medicaid Services     Dear Acting Administrator Tavenner:   As life science trade associations representing thousands of companies that are...
PDUFA V: BIO Comments on FDA's NME Review Program Assessment
August 5, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the statement of work for the independent assessment of the Prescription Drug User Fee...
Accelerated Approval: BIO Comments on pCR in Neoadjuvant Treatment for Breast Cancer
July 29, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry Pathologic Complete Response in Neoadjuvant...
The 10th Anniversary of the Sarbanes-Oxley Act, Jeffrey S. Hatfield, President and Chief Executive Officer, Vitae Pharmaceuticals
July 26, 2012
Jeffrey S. Hatfield, President and Chief Executive Officer, Vitae Pharmaceuticals On behalf of the Biotechnology Industry Organization Before the United States House of Representatives Committee on Financial Services, Subcommittee...
Development of the Joint Strategic Plan on Intellectual Property Enforcement: BIO Comments
July 25, 2012
The United States Patent and Trademark Office (USPTO) has led the world in providing technical expertise and training to various patent and trademark offices around the world.  However, when the judiciary in the markets of important trading...
BIO's Letter of Support for the Intellectual Property Attaché Act
July 11, 2012
 Dear Chairman Smith and Ranking Member Conyers: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Intellectual Property Attaché Act, which you introduced along with...
Agricultural Biotechnology: Federal Agriculture Reform and Risk Management Act of 2012
July 10, 2012
Dear Chairman Lucas and Ranking Member Peterson: Our members are engaged in the development, use and future utilization of agricultural products derived through modern biotechnology, and support comprehensive and efficient regulation of these...
REMS: BIO Comments on Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge
July 6, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on “Risk Evaluation and Mitigation Strategy Assessments: Social Science...
Unique Names for Biosimilar Products: Letter to Commissioner Hamburg
July 3, 2012
IP Attache Program: BIO's Congressional Hearing Comments
June 27, 2012
  The U.S. Intellectual Property Rights Attaché Program has had significant success and holds immense promise in helping to enhance IP protection abroad for U.S. interests. This international focus is imperative, given that that more...
Oppose Costly & Confusing Labeling Amendment to the Agriculture Reform, Food and Jobs Act of 2012
June 21, 2012
Senators Sanders and Boxer have introduced an amendment that will result in costly and extreme food labeling requirements. Senate Amendment 2310 to the Agriculture Reform, Food and Jobs Act of 2012 opens the door for states to require that...
The Farm Bill: BIO Opposes the Sanders-Boxer Amendment
June 21, 2012
The Biotechnology Industry Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations around the world, strongly opposes the Sanders-Boxer Amendment...
2012 BIO International Convention Chair's Keynote, H. Thomas Watkins of Human Genome Sciences
June 20, 2012
 Thank you.  It's GREAT to be in BOSTON! MANY people think of BOSTON...as one of the world's GREATEST centers of excellence in EDUCATION...and it CERTAINLY IS. With the Boston CELTICS...RED SOX...BRUINS...and New England...
Celebrating the Promise of Biotechnology, 2012 Biotechnology Industry Address, Jim Greenwood, President and CEO BIO
June 19, 2012
We just heard our chairman Tom Watkins say "We're doing big things." Sounds good, but is that just hype, or is it for real? It's real. Together we do really big things. Today, I want to brag about some of the really big...
AMP v. USPTO Remand: BIO Files Supplemental Brief
June 17, 2012
  The Federal Circuit Court previously concluded that the claimed isolated genomic DNA and cDNA molecules in this case are patentable compositions of matter. Nothing in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S...
BIO Comments on IOM Report - Ranking Vaccines: A Prioritization Framework
June 15, 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National...
BIO Comments on IOM Report - Ranking Vaccines: A Prioritization Framework
June 15, 2012
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National...
More than Myriad: Gene Patent Discussion Must Not Forget Industrial, Environmental, Food and Agricultural Biotech
June 11, 2012
On behalf of the 23 undersigned industrial, environmental, food and agricultural biotechnology companies, we write to express our concerns over the pending appeal in the case of Association for Molecular Pathology et al. v. Myriad Genetics et al (...