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Letters, Testimony & Comments

Statement in Support of Virginia H.B. 1422
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...
340B: BIO’s Comments to HRSA Regarding the Burden to Conduct 340B Audits
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...
EHB: BIO’s Comments on the Essential Health Benefits Proposed Rule
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...
Pandemic and All-Hazards Preparedness Reauthorization Act
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...
BIO Comments on EMA Guideline on Biosimilar Quality Issues
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...
India Traditional Knowledge and Biological Material Draft Guidelines: Biotech Industry Provides Input
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...
BIO Submits PAHPA Reauthorization Support Letter
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...
India’s Draft National IPR Strategy: BIO Comments
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...
Unique Device Identification System 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...
Biosimilar Patent Certification: University Associations Ask FDA to Not Undermine Their Patent Rights
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...
BIO and Other Industry Organizations Urge Congressional Leadership to Oppose any Waiver of RFS Requirements
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...
The Renewable Fuels Standard: A Successful Federal Policy that Must Be Defended
October 17, 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...
BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations
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...
Organic Seed Growers v. Monsanto: BIO and CLA File Amicus Brief
September 19, 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...
CER: BIO’s comments on PCORI’s Draft Methodology Report
September 13, 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...
Mexico's TPP Entry: BIO Submits Comments to USTR
September 4, 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...
Medicare Program: BIO's Comments on the Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2013; Proposed Rule
September 3, 2012
Re:  Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule; Proposed Rule [CMS-1590-P] Dear Acting Administrator Tavenner:             The Biotechnology...
BIO's Comments to the CY 2013 Outpatient Prospective Payment System (OPPS) Proposed Rule
September 3, 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...
Canada's Trans-Pacific Partnership (TPP) Entry: BIO Submits Comments to USTR
September 3, 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...
Biofuels Producers Coordinating Council Asks President Obama to Stay the Course on RFS
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...