Letters, Testimony & Comments

February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services...
March 27 2014
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing with our...
December 18 2012
A keynote Address by James C. Greenwood, President & CEO of BIO, to RETECH 2012 in Washington, DC on October 18, 2012. When Admiral...
October 18 2012
The U.S. Intellectual Property Rights Attaché Program has had significant success and holds immense promise in helping to enhance...
June 28 2012
Senators Sanders and Boxer have introduced an amendment that will result in costly and extreme food labeling requirements. Senate...
June 21 2012
The Biotechnology Industry Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state...
June 21 2012
Good morning Chairman Rehberg, Ranking Member DeLauro, Members of the Committee, ladies, and gentlemen. I am Scott Koenig, President and...
March 20 2012
Dear Majority Leader Reid and Minority Leader McConnell: On behalf of the Biotechnology Industry Organization (BIO) and its more than 1...
March 16 2012
William D. Waddill, Senior Vice President and Chief Financial Officer OncoMed Pharmaceuticals highlights the importance of capital...
March 6 2012
On December 1, BIO submitted written testimony to the Senate Committee on Banking, Housing, and Urban Affairs on the importance of...
December 1 2011
The Biotechnology Industry Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business...
July 28 2011
The Honorable Michael J. Rogers 133 Cannon HOB U.S. House of Representatives Washington, DC 20515 Dear Representative Rogers: On...
July 25 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
July 25 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
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
Dear Chairman Frelinghuysen and Ranking Member Visclosky: On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
May 17 2011
Dear Chairman Upton, Chairman Boxer, Ranking Member Waxman, and Ranking Member Inhofe: As the leading advocates of the U.S. biofuels...
May 17 2011
TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INDUSTRY...
May 17 2011
Dear Secretary Locke: On behalf of the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of...
May 13 2011
Dear Chairman Kingston and Ranking Member Farr: On behalf of the Biotechnology Industry Organization (BIO), I am writing to encourage...
May 12 2011
Testimony of Phyllis Arthur, Senior Director for Vacines, Immunotherapeutics and Diagnostoics Policy Senate HELP Committee Good...
May 11 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
April 29 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The...
April 28 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
Hearing Testimony Phyllis Arthur Senior Director for Vaccines, Immunotherapeutics and Diagnostics Policy at the Biotechnology...
April 13 2011
Committee on Environment and Public Works United States Senate Oversight Hearing on Domestic Renewable Fuels: From Ethanol to Advanced...
April 13 2011
The Biotechnology Industry Organization ("BIO") is pleased to submit responses to question numbers 1,2, 4, 5, and 6 of the...
April 11 2011
Re: Comments on Section 6002 of the Affordable Care Act Dear Sir or Madam: BIO appreciates the opportunity to comment on the...
April 7 2011
Re: Docket No. FDA–2010–D–0643: Electronic Source Documentation in Clinical Investigations Dear Sir/Madam: The...
April 7 2011
Hearing Testimony Scott Koenig, M.D., PH.D. Before the House of Representatives Committee on Small Business Good morning Chairman...
April 7 2011
E mail - ImprovingRegulations.SuggestionBox@epa.gov RE: Docket ID No. EPA-HQ-OA-2011-0157 (Improving Regulations: Pesticides) and EPA-...
April 4 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear...
April 1 2011
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1,100 member companies, academic institutions, state...
March 24 2011
March 24, 2011 As our economy begins to improve, job creation remains a critical priority toward ensuring a broad, deep and sustained...
March 24 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry Dear Sir/Madam: The...
March 8 2011
RE: Request for comments on Appendix 3 of the Chairperson’s Report on the November 15-16, 2010 Facilitated Work Session of the...
March 4 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of...
March 2 2011
HHS-OS-2010-002: Request for Information Regarding Value-based Insurance Design in Connection with Preventive Care Benefits The...
March 1 2011
Comments of Biotechnology Industry Organization on EPA’s Draft Report Biofuels and the Environment: First Triennial Report to...
February 28 2011
Dear Majority Leader Reid and Minority Leader McConnell: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels...
February 25 2011
RE: Draft Update to Chapter 4 of the Medicare Managed Care Manual Dear Ms. Moon: The Biotechnology Industry Organization (BIO) is...
February 24 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The...
February 22 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 24 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year...
January 11 2011
Re: Docket No. FDA-2010-D-0319 Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters:...
January 11 2011
Dear President Obama: The organizations below urge your Administration to maintain robust funding levels for the Department of...
January 11 2011
January 7, 2011 President's Council of Advisors on Science and Technology (PCAST) Public Oral Comments Ladies and Gentlemen:...
January 11 2011
Farmers Successfully Practice Coexistence USDA must base its decision to deregulate GE alfalfa on science and within its existing...
January 6 2011
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
Dear Mr. Sunstein: The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns...
December 23 2010
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and...
December 23 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (...
December 16 2010
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very...
December 7 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets...
December 6 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-...
December 3 2010
Dear Honorable Sander Levin and Honorable Dave Camp, We applaud your ongoing leadership on strengthening U.S. manufacturing and...
December 1 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this...
November 19 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this...
November 19 2010
Re: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System, 75 Fed. Reg....
November 19 2010
Re: (Docket No. FDA-2010-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology...
November 19 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic...
November 1 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs...
October 29 2010
Dear President Obama: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass...
October 21 2010
Dear Secretary Vilsack: For the past 15 years, agricultural products derived from modern biotechnology have provided significant...
October 4 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza...
October 1 2010
The Biotechnology Industry Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business...
October 1 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100...
September 30 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for...
September 20 2010
Dear President Obama: We are writing to ask for your support to provide additional guidance to the Department of Energy’s (DOE)...
September 20 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 17 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare...
August 13 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act....
August 13 2010
BIO advocated for the recently enacted new Therapeutic Discovery Project Credit program, which was created as a unique opportunity for...
August 3 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately...
July 20 2010
Comments of Biotechnology Industry Organization on EPA’s Call for Information on Greenhouse Gas Emissions Associated with Bioenergy...
June 13 2010
Dear Chairman Inouye and Ranking Member Cochran: As the Senate debates fiscal year 2011 federal funding, the undersigned organizations...
June 1 2010
Re: Draft 2011 Part D Call Letter Dear Acting Administrator Frizzera: The Biotechnology Industry Organization (BIO) appreciates this...
March 5 2010
Letter to Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Charles Grassley (R-Iowa), asking for recognition of...
March 3 2010
Office of Medicine, Science, and Public Health Office of the Assistant Secretary for Preparedness and Response, FAO Jessica Tucker, Ph....
January 26 2010
As Congress considered healthcare reform patient advocacy groups submitted a letter to Congressional leadership asking for their support...
November 19 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
Dear Secretary Vilsack: We are writing today to bring to your attention a court case that has the potential to negatively impact the...
September 9 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
Re: Department of Agriculture, Office of the Secretary; Solicitation of Input from Stakeholders on the Roadmap for Agricultural Research...
May 31 2009
   Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States House of Representatives...
April 30 2009
Good morning Chairman Wu, Ranking Member Smith, Members of the Committee, ladies and gentleman. I am Jim Greenwood, President and CEO of...
April 23 2009
Re: Docket No. FDA-2009-D-0675, OC 20091. Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13 2009
Re: CMS-4138-IFC4 (Medicare Program; Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes...
March 17 2009
 Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States Senate Committee on the...
March 10 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability...
January 21 2009
RE: Chapter 305 of the Acts of 2008, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health...
November 6 2008
To whom it may concern: The Food and Drug Administration (FDA) has requested comments relevant to the implementation of Sec. 912 of the...
October 27 2008
Re: Docket No. FDA-2008-D-0417: Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings; Availability...
October 6 2008
Dear Chairman Pallone and Ranking Member Deal: On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
Dear Secretary Schafer: The Biotechnology Industry Organization (BIO) believes it is critical that the U.S. Department of Agriculture (...
April 15 2008
Re: Special 301: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment, 73 Fed. Reg. 2958 (...
February 11 2008
Re: Comments on Draft CY 2009 Call Letter Dear Dr. Tudor: The Biotechnology Industry Organization (BIO) appreciates this opportunity to...
January 30 2008
Re: CMS-1392-FC (Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates) Dear...
January 28 2008
Re: CMS-2238-P (Medicaid Program; Prescription Drugs) Dear Acting Administrator Weems: The Biotechnology Industry Organization (BIO)...
December 21 2007
BIO's comments on the SACGHS draft report
December 21 2007
Dear Speaker Pelosi, Rep. Obey, Rep. Lewis, and Rep. Walsh, On behalf of the undersigned organizations, representing the life sciences...
October 25 2007
The Biotechnology Industry Organization (BIO) appreciates this opportunity to provide the perspective of its members on the role of...
October 24 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
The Biotechnology Industry Organization (BIO) appreciates this opportunity tp provide the perspective of its members on the Bayh-Dole Act...
August 27 2007
Dear Senator: We are writing to convey our strong support for clean, renewable and domestic energy production. Accordingly, we urge you...
July 30 2007
The Biotechnology Industry Organization (BIO) is pleased to submit these comments in response to the supplemental proposals for plant-...
July 17 2007
The Biotechnology Industry Organization (BIO) is pleased to submit these comments in response to the Advance Notice of Proposed...
July 13 2007
BIO's Comments on the SACGHS draft report.
June 1 2007
Dear Chairman Baucus and Ranking Member Grassley:   We applaud your commitment to continue reviewing trade preference programs to...
May 16 2007
The Statement of the The Biotechnology Industry Organization On H.R. 1908, The Patent Reform Act of 2007 The United States House of...
April 26 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 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
Leon R. Kass, M.D., Chairman The President's Council on Bioethics 1801 Pennsylvania Avenue, NW Suite 800 Washington, DC 20005...
April 15 2003
We respectfully request that the Senate Appropriations Subcommittee of Labor, Health and Human Services, Education and Related Agencies...
Dear Ms. Tipton, Mr. Kozak and Mr. Suber: On behalf of the Biotechnology Industry Organization (BIO), I urge the International Dairy...
Re: Docket No. AMS-TM-07-0032; TM-07-05, Notice of Meeting of the National Organic Standards Board [Federal Register: March 12, 2007 (...
Dear Senators Reid and McConnell: On behalf of the more than 430 undersigned organizations representing American innovation from all 50...
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on the proposed regulations to implement...
April 29 2014
Chairperson Mikulski, Ranking Member Shelby, Members of the Committee, thank you for the opportunity to provide you with written testimony on the extremely important topic of driving innovation through federal investments.
March 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”).   
March 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.   
December 18 2012
BIO President and CEO Jim Greenwood wrote a letter in support of H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2012, sponsored and championed by Chairman Mike Rogers (R-MI).
October 18 2012
A keynote Address by James C. Greenwood, President & CEO of BIO, to RETECH 2012 in Washington, DC on October 18, 2012.
September 17 2014
Legislation aimed at enhancing capital access and creating jobs
July 31 2014
Washington, D.C. (July 31, 2014) – The Biotechnology Industry Organization (BIO) today encourages support for the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation (COMPETE) Act, introduced today by Senator Tom Carper (D-DE). 
April 9 2014
Consumer-focused legislation will enhance transparency and advance food safety Washington, D.C. (April 9, 2014) – The Biotechnology Industry Organization (BIO), applauds today’s introduction of the Safe and Accurate Food Labeling Act, which would establish a federal standard for the safety and labeling of food and beverage products made with genetically modified ingredients (GMOs).
March 11 2014
BIO commended the Centers for Medicare & Medicaid Services (CMS) for announcing their decision to halt movement on several proposals in their Medicare Part D draft rule.
February 12 2014
Bill would spur capital formation for small public companies