Letters, Testimony & Comments

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...
October 4, 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for...
September 20, 2012
INTRODUCTION BIO and CLA submit this brief in support of the decision below, and also to counter the troubling and unsubstantiated assertions of the amici in support of the Appellants. BIO and CLA reject the proposition that this Court’s...
September 14, 2012
Re:  Patient-Centered Outcomes Research Institute (PCORI) Draft Methodology Report Dear Dr. Selby: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Patient-Centered Outcomes Research...
September 5, 2012
BIO supports the President’s decision to include Mexico in the TPP trade negotiations. Providing effective intellectual property protection for biological products is a central focus for BIO and its members. The TPP provides an excellent...
September 4, 2012
I. Agricultural and Animal Biotechnology The Government of Canada has long been a trusted ally to the United States on agricultural biotechnology. Canada has been a like minded partner in various international fora, including joining the United...
September 4, 2012
Re:      Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality...
September 4, 2012
Re:  Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule; Proposed Rule [CMS-1590-P] Dear Acting Administrator Tavenner:             The Biotechnology...
August 27, 2012
Dear Mr. President, The drought impacting the United States has already caused millions of dollars in economic damages to rural America. By all accounts, the drought of 2012 has been historic: more than one-fifth of the continental United States...
August 17, 2012
The Biotechnology Industry Organization (BIO) appreciates the U.S. Trade Representative's (USTR) query about BIO's views on how intellectual property should be treated in any future agreement arising from the U.S.- EU High Level Dialogue....
August 17, 2012
Dear Mr. Reed: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Draft Methodology for Estimating National Average Retail Prices (NARP) for Medicaid Covered Outpatient Drugs, commissioned from Myers...
August 14, 2012
Marilyn Tavenner Acting CMS Administrator Centers for Medicare and Medicaid Services     Dear Acting Administrator Tavenner:   As life science trade associations representing thousands of companies that are...
August 6, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the statement of work for the independent assessment of the Prescription Drug User Fee...
July 30, 2012
  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 Industry Pathologic Complete Response in Neoadjuvant...
July 26, 2012
Jeffrey S. Hatfield, President and Chief Executive Officer, Vitae Pharmaceuticals On behalf of the Biotechnology Industry Organization Before the United States House of Representatives Committee on Financial Services, Subcommittee...
July 26, 2012
The United States Patent and Trademark Office (USPTO) has led the world in providing technical expertise and training to various patent and trademark offices around the world.  However, when the judiciary in the markets of important trading...