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Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization

Mar 2 2017
What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.

BIO's Testimony in Opposition to Maryland's House Bill 666

Feb 27 2017

BIO Submits Comments on FDA proposed rule: Good Laboratory Practice for Nonclinical Laboratory Studies

Jan 30 2017
RE: Docket No. FDA-2010-N-0548: The Biotechnology Innovation Organization (BIO) appreciates the opportunity to offer comments to Food and Drug Administration (FDA)’s “Good Laboratory Practice for Nonclinical Laboratory Studies.” 

BIO submits comments to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models

Dec 23 2016
The Biotechnology Innovation Organization appreciates the opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

BIO Comments on the National Quality Forum Health and Wellbeing 2015-2017 Report

Dec 23 2016
BIO appreciates the opportunity to comment on the National Quality Forum (NQF) Health and Wellbeing 2015-2017 report.

BIO Submits Comments on FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

Dec 23 2016
Re: Docket No. FDA-2016-N-0001: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices” 

BIO Urges the Senate to Pass the 21st Century Cures Act

Dec 7 2016
On behalf of the Biotechnology Innovation Organization (BIO), I am writing to offer our strong support H.R. 34, the 21st Century Cures Act, and urge the Senate to pass this important legislation.

New York U.S. Congressional Delegation Sends Letter to PTO Head Michelle Lee

Dec 7 2016
Ten members the U.S. House of Representatives from New York wrote to U.S. Patent and Trademark Office Director Michelle K. Lee to express concern with continued abuse of the inter partes review (IPR) system by financial speculators and other third parties with no legitimate interests in the patented technology

DSCSA: BIO Submits Comments to FDA's Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act

Nov 23 2016
Re: Docket No. FDA–2016–N–2673: Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act ...

BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration

Nov 18 2016
Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.