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Letters, Testimony & Comments

Biosimilars: BIO Comments on Scientific Considerations
April 16, 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference...
CED: BIO's Comments to the the Medicare Evidence Development & Coverage Advisory Committee’s (MEDCAC) questions regarding the evidentiary characteristics of coverage with evidence development (CED)
April 15, 2012
Re: Request for Comments Regarding Evidentiary Characteristics of Coverage with Evidence Development Dear Ms. Ellis:            The Biotechnology Industry Organization (BIO) appreciates this...
Agriculture Energy Coalition Letter to House and Senate Agriculture Committees
April 6, 2012
  Dear Senators Stabenow and Roberts and Representatives Lucas and Peterson: The U.S. is experiencing strong growth in the development and commercialization of biofuels, bioproducts, biopower, biogas, energy crops, renewable energy and...
2012 AMP Proposed Rule: BIO's Comments on the Centers for Medicare and Medicaid Services’ Proposed Rule regarding covered outpatient drugs under the Medicaid Program
April 1, 2012
Re:      CMS-2345-P (Proposed Rule, Medicaid Program; Covered Outpatient Drugs) Dear Ms. Tavenner: The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments to the Centers...
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
March 29, 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name is Sara Radcliffe and I am Executive Vice President for Health for the Biotechnology Industry Organization (BIO...
BIO Comments to FDA on Scientific Exchange related to Off-Label Information
March 26, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or the Agency) for the opportunity to submit comments on this important topic.  The ability to exchange scientific information with...
BIO Comments to FDA on Unsolicited Requests for Off-Label Information
March 26, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Agency’s Draft Guidance for Industry on Responding to Unsolicited requests for Off-...
Supplemental Examination: BIO Comments on Patent Reform
March 25, 2012
From BIO’s perspective, Supplemental Examination may have significant benefits, because patents that undergo this process are expected to be stronger, clearer, and can be better relied on for investment, product development, and commerce....
BIO's Testimony to the House Appropriations, Labor HHS Subcommittee on the President's FY 2013 Budget Request for the National Institutes of Health (NIH)
March 20, 2012
Good morning Chairman Rehberg, Ranking Member DeLauro, Members of the Committee, ladies, and gentlemen. I am Scott Koenig, President and Chief Executive Officer of MacroGenics, Inc. and Chairman of the Board of Applied Genetic Technologies Corp (...
BIO Supports the JOBS Act (H.R. 3606)
March 16, 2012
Dear Majority Leader Reid and Minority Leader McConnell: On behalf of the Biotechnology Industry Organization (BIO) and its more than 1,100 members, I am writing in strong support of H.R. 3606, the Jumpstart Our Business Startups (JOBS) Act. I...
PCORI Draft National Priorities and Research Agenda: BIO's Comments
March 14, 2012
RE: Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda Dear Dr. Selby:                     ...
AIA Oath or Declaration: BIO Comments
March 7, 2012
Selected Excerpts: The vast majority of BIO’s members are small and medium sized enterprises that currently do not have products on the market. However, all of our members actively file for patents and often pursue both out-licensing and...
Spurring Job Growth Through Capital Formation While Protecting Investors
March 6, 2012
William D. Waddill, Senior Vice President and Chief Financial Officer OncoMed Pharmaceuticals highlights the importance of capital formation to encourage investment in the biotechnology industry and spur job growth across the country....
2013 Draft Call Letter: BIO's Comments to CMS
March 2, 2012
Re: Draft 2013 Call Letter Dear Mr. Blum and Mr. Spitalnic: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) draft 2013 Call Letter.  BIO...
Letter to the Texas Health and Human Services Commission Regarding Proposed Specialty Pharmacy Rule
March 1, 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health Insurance Program P.O. Box 85200 Austin, TX 78708 Comments on the Proposed Rule Regarding Specialty Drugs...
Good Guidance Practices: FDA Report on Good Guidance Practices: Improving Efficiency and Transparency
February 29, 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on the FDA Report on Good Guidance Practices: Improving Efficiency and Transparency. BIO represents more than 1,...
Biologics: BIO Comments on EMA 'Concept Paper on the Revision of the Guideline on Similar Biological medicinal Product"
February 29, 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the "concept paper on the revision of the guideline on similar biological medicinal product."...
PCORI National Patient and Stakeholder Dialogue: BIO's Public Statement
February 27, 2012
BIO Public Statement: National Patient and Stakeholder Dialogue Thank you for the opportunity to present comments on behalf of the Biotechnology Industry Organization, which supports PCORI's goal of increasing the availability of...
Safety Labeling: Establishing Timeframes for Implementation of Product Safety Labeling Changes
February 21, 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 the notice, “Establishing Timeframes for Implementation of...
USPTO Genetic Testing Study: BIO's Testimony
February 17, 2012
If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can...