Letters, Testimony & Comments

Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
October 4 2012
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
October 14 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid...
July 23 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
August 15 2010
BIO supports the view that a system of genetic test registration is necessary to provide stakeholders with information about the spectrum...
August 2 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology...
May 27 2010
House Health and Government Operations Committee March 12, 2009 House Bill 1155-Prescription Confidentiality Act BIO opposes House...
March 12 2009
Re: FR Doc. E8-31195: HHS Action Plan to Prevent Healthcare-Associated Infections To whom it may concern: The Biotechnology Industry...
February 6 2009
Subject: Department of Health, Chapter 83, Pharmaceutical Detailers, of Title 17, Business Occupations and Professions, of the District...
July 24 2008
Re: Dear Manufacturer Letter Dated February 1, 2008 Dear General Granger: The Biotechnology Industry Organization (BIO) appreciates...
April 10 2008
BIO's comments on the SACGHS draft report
December 21 2007
Re: Docket No. 2006D-0347, Federal Register: July 26, 2007 (Volume 72, Pages 41081- 41083) Dear Sir/Madam, The following comments...
August 27 2007
BIO's comments on the CMS' Proposed Decision Memorandum.
August 17 2007
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The...
July 11 2007
BIO's Comments on the SACGHS draft report.
June 1 2007
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
February 2 2004
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of...
June 24 2003
July 23 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013.
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
October 4 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for Medicare and Medicaid Services (CMS) on August 31, 2012. 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 biotechnologies, thereby expanding the boundaries of science to benefit society by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. Specifically related to advanced personalized diagnostic products, a number of BIO companies develop and market in vitro diagnostic technologies for a variety of research, investigational, and clinical uses. BIO is deeply concerned with CMS’ payment proposal regarding Multi-Analyte Assays with Algorithmic Analyses (MAAAs), and is concerned generally with the lack of transparency in the process through the annual CLFS meeting and publication of the proposed payment methodologies. BIO believes these proposed payments will threaten access to molecular pathology tests by Medicare beneficiaries and have a devastating impact on the advancement of personalized medicine.
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations. 
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.
September 29 2010
BIO President and CEO Jim Greenwood released the following statement on action by the U.S. Circuit Court of Appeals last night to stay the lower court’s injunction on federally funded embryonic stem cell research...
May 4 2010
A new report issued by the Biotechnology Industry Organization underscores how biotechnology is benefiting society now more than ever, and is poised to help address some of the world’s most pressing challenges.