Letters, Testimony & Comments

January 28, 2013
Dear Dr. Jacques:            The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers for Medicare and Medicaid Services’ (CMS) Draft...
January 24, 2013
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are not chemically synthesized but rather are manufactured from living cells by programming a particular cell line...
January 24, 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations...
January 24, 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations...
January 22, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”  BIO...
January 22, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities...
January 18, 2013
Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and is pleased to provide suggestions for possible improvement within the framework of the...
January 10, 2013
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H.B. 1422). This proposed legislation seeks to permit pharmacists to dispense a biosimilar drug that has been...
December 21, 2012
The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments in response to “Proposed Collection:  Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)—Extension” (the...
December 21, 2012
          The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services' (HHS) proposed rule on the essential health...
December 18, 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing with our support for H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2012, sponsored...
November 30, 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit comments on the “Guideline on similar biological medicinal products containing biotechnology-derived...
November 28, 2012
Draft Guidelines Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has reviewed the Guidelines and has identified specific questions, and areas for improvement....
November 16, 2012
  Dear Chairmen Harkin, Upton and Pitts, Ranking Members Enzi and Waxman, Senators Burr and Casey, and Rep. Rogers:   On behalf of the undersigned organizations, we urge you to finalize negotiations on the Pandemic and All-Hazards...
November 8, 2012
The Biotechnology Industry Organization (BIO) is grateful for the opportunity to provide comments on India’s Draft National IPR Strategy, hereafter referred to as "Draft Strategy".  Moreover we applaud the Government of India...
November 7, 2012
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit...
November 5, 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised by the proposed regulatory pathway for the dispute resolution for biosimilar and interchangeable biological...
October 18, 2012
October 18, 2012 Dear Majority Leader Reid and Speaker Boehner and Minority Leaders McConnell and Pelosi, The drought impacting the United States has already caused millions of dollars in economic damages to rural America. By all...
October 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 McGinn invited me to be part of RETECH 2012, I agreed immediately. Because now is the time for a call to arms...