Letters, Testimony & Comments

Chairperson Mikulski, Ranking Member Shelby, Members of the Committee, thank you for the opportunity to provide you with written...
April 29 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services...
March 27 2014
November 6, 2013 The Honorable Robert Menendez 528 Hart Senate Office Building United States Senate Washington, D.C....
November 6 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
Kenneth I. Moch President and Chief Executive Officer, Chimerix, Inc. On behalf of the Biotechnology Industry Organization Before the...
July 10 2013
Introduction The Biotechnology Industry Organization (BIO) appreciates the opportunity to respond to the Request for Comments issued by...
June 3 2013
The Honorable Rick Scott Office of the Governor State of Florida 400 S. Monroe St. Tallahassee, FL 32399-0001 Dear Governor Scott...
May 8 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 8 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 7 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety...
April 19 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
April 12 2013
Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations;...
March 26 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
March 18 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
March 14 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
March 4 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 19 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on...
February 4 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are...
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...
January 24 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing with our...
December 18 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit...
November 30 2012
  Dear Chairmen Harkin, Upton and Pitts, Ranking Members Enzi and Waxman, Senators Burr and Casey, and Rep. Rogers:   On...
November 16 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 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
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
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and...
May 31 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
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
February 29 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 2012
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings The Biotechnology Industry Organization (BIO)...
January 20 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
January 17 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
January 9 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
December 23 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
December 16 2011
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture...
December 13 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human...
October 26 2011
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the...
October 24 2011
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications...
October 19 2011
RE: Comments Regarding the Draft Guidance on In Vitro Companion Diagnostic Devices; FDA-2011-D-0215 Dear Sir/Madam: The Biotechnology...
October 14 2011
  Re:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 30 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the core set of health quality measures for the...
August 9 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
July 25 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
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear...
April 1 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
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of...
February 1 2011
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs."...
October 29 2010
October 14, 2010 To: Members of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological...
October 14 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines...
August 16 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 submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use...
July 15 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner...
June 21 2010
Senate Finance Committee Member: On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
Dear Chairman Inouye and Ranking Member Cochran: As the Senate debates fiscal year 2011 federal funding, the undersigned organizations...
June 1 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...
May 31 2010
BIO proposes that the guidance make it more clear which methods are being proposed, as early as possible and consistently throughout the...
May 27 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology...
May 27 2010
Access to Early Capital In the United States and globally, commercial development of biotechnology relies on the continuing...
May 27 2010
Office of Medicine, Science, and Public Health Office of the Assistant Secretary for Preparedness and Response, FAO Jessica Tucker, Ph....
January 26 2010
Comments on the “Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination” Dear...
December 14 2009
Dear Ms. Blue, This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comment...
November 3 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
RE: SEC Release No. 34-60611 Dear Deputy Secretary Harmon: On behalf of its members, the Biotechnology Industry Organization (“...
September 29 2009
Re: Docket No. FDA- 2008-D-0253. Presenting Risk Information in Prescription Drug and Medical Device Promotion   Dear Sir/...
August 25 2009
Re: Docket No. FDA-2009-N-0247, Food and Drug Administration Transparency Task Force, Public Meeting Dear Sir/Madam: The...
August 5 2009
  VIEWS AND PROPOSALS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF...
July 31 2009
Re: Docket No. FDA-2009-D-0179, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological...
July 27 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
Re: Docket No. NIH-2008-0002 RIN 0925-AA53, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health...
July 7 2009
Re: Docket No. FDA- 2009-D-0132 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
July 1 2009
Re: Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List; Federal Register...
June 30 2009
Re: Docket Ref. EMEA/410/01-Rev. 4 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the European Medicines...
June 30 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: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure, Function, and Scope; Public Workshop   Dear Sir/...
March 27 2009
Re: Docket No. FDA- 2009-D-2007. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule Dear Sir/Madam: The...
March 23 2009
 Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States Senate Committee on the...
March 10 2009
Re: BIO submits comments to EITF 08-1 Dear Mr. Golden: On behalf of its members, the Biotechnology Industry Organization (“BIO...
January 23 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability...
January 21 2009
IDEAS FOR REFORM OF THE UNITED STATES PATENT AND TRADEMARK OFFICE Dear President-Elect Obama: Congratulations on your historic...
December 17 2008
Re: Docket No. FDA-2008-D-0514: End-of-Phase 2A Meetings Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the...
November 25 2008
Re: Docket No. FDA-2008-D-0386: International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report;...
November 3 2008
Re: Draft Annex 11 “Computerised Systems” Dear Sir/Madam, The Biotechnology Industry Organization (BIO) appreciates the...
October 31 2008
Re: Section 102 Certificate Requirements Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Consumer Product...
October 31 2008
Dear Chairman Cox: On behalf of its members, the Biotechnology Industry Organization (“BIO”) is pleased to provide comments...
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
Re: OMB control number 0910-0616, Docket No. FDA-2008-N-0144, Agency Information Collection Activities; Submission for Office of...
September 26 2008
Re: BIO Comments Regarding Expansion of the ClinicalTrials.gov Database Dear Dr. Zarin and Dr. Morton: The Biotechnology Industry...
September 8 2008
Re: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
Re: DoH Call for Comments 08/2008 Dear Sir or Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 2008
Re: FDA Docket 2008N–0281: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting Dear Sir/Madam:...
July 31 2008
Re: FDA Docket 2008N–0257: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment Dear Sir...
June 19 2008
Re: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
RE: Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigational Medicinal...
May 30 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
Supporting the Genetic Information Nondiscrimination Act (GINA)
February 7 2006
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE JUDICIARY COMMITTEE OF THE UNITED STATES SENATE IMPORTATION OF...
July 14 2004
Re: Docket No. 2004N-0115 Request for Comment on Prescription Drug Importation Dear Dr. Carmona and Members of the HHS Task Force on...
June 1 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, & PENSIONS OF THE...
May 20 2004
April 14, 2004, 9:00 a.m. -5:00 p.m. Natcher Auditorium, Building 45, National Institutes of Health (NIH) 9000 Rockville Pike,...
April 14 2004
Leon R. Kass, M.D., Chairman The President's Council on Bioethics 1801 Pennsylvania Avenue, NW Suite 800 Washington, DC 20005...
April 15 2003
Good morning, ladies and gentlemen. My name is Carl Feldbaum, and I'm here today to talk about the major political and regulatory forces...
May 9 2002
Dear Dr. Sim: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
BIO advocated for a provision in financial services reform that would ease regulatory burdens for small public biotechnology companies....
Dear Chairman Schapiro: The Biotechnology Industry Organization (BIO) thanks the Securities and Exchange Commission (SEC or Commission)...
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on the proposed regulations to implement...
July 14 2014
Dear Chairman Terry and Ranking Member Schakowsky: On behalf of the Biotechnology Industry Organization (BIO), I write in support of H.R. ___, the Targeting Rogue and Opaque Letters (TROL) Act of 2014, and urge the Subcommittee to pass this legislation. It is critical that legislation that seeks to reign in abuses by patent trolls does so in a way that preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country. Improving our patent system can help America retain its global competitive advantage in biotechnology and other innovative industries, and will spur more investment and job creation at a time when both are sorely needed. We commend Chairman Terry and Members of the Subcommittee on Commerce, Manufacturing, and Trade for creating a balanced approach that will address the issue of false or deceptive patent demand letters without impeding the ability of legitimate patent owners to enforce their patents by sending patent-related communications made in good faith.
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.   
November 6 2013
On behalf of the BIO and its 1,100 members, I am writing in strong support of your Start-up Jobs and Innovation Act. I want to thank you for introducing this important legislation, which will spur investment in small biotech companies and other innovative businesses.
July 10 2014
The International Council of Biotechnology Associations has been established with the expressed purpose of advocating for public policies that support the growth of the innovative biotechnology industry worldwide.
June 24 2014
Bioscience industry a bright spot among the technology sector
May 29 2014
Delaware Governor Markell signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
May 16 2014
BIO and Delaware Bio call upon Governor Markell to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines.
April 10 2014
BIO and Delaware Bio commend the Delaware State Senate for unanimously passing legislation yesterday designed to create a pathway for the substitution of interchangeable biologic medicines.