Letters, Testimony & Comments

May 2, 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food and Drug Administration Safety and Innovation Act (FDASIA). I commend you for introducing this strong,...
April 26, 2012
  The House Judiciary Committee conducted a hearing on World IP Day on "International Patent Issues: Promoting a Level Playing Field for American Industry Abroad."  BIO submitted written comments for the...
April 18, 2012
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, 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...
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics...
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference...
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference...
April 16, 2012
Re: Request for Comments Regarding Evidentiary Characteristics of Coverage with Evidence Development Dear Ms. Ellis:            The Biotechnology Industry Organization (BIO) appreciates this...
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...
April 2, 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...
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...
March 27, 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-...
March 27, 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...
March 26, 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....
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 (...
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...
March 15, 2012
RE: Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda Dear Dr. Selby:                     ...
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...
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....
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...