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BIO Applauds House Passage of Food and Drug Administration Reauthorization Act (FDARA)

Urges swift Senate vote to ensure continuity of critical FDA functions   Washington, DC (July 12, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. House of Representatives:

BIO Congratulates Dr. Scott Gottlieb on Confirmation as FDA Commissioner

Washington, DC (May 9, 2017) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the confirmation of Dr. Scott Gottlieb as Commissioner of the Food and Drug Administration (FDA):

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

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 Statement on President Trump’s Comments Supporting Biopharmaceutical Competition and Innovation

Washington, DC (January 31, 2017) – BIO issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

BIO Applauds Senate Passage of the 21st Century Cures Act

Washington, DC (December 7, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. Senate:

BIO Applauds House Passage of the 21st Century Cures Act

Washington, DC (November 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. House of Representatives:

BIO Statement on FDA Product Communications Hearing

BIO President and CEO Jim Greenwood released the following statement today regarding the FDA’s hearing on product communications: “In the era of data-driven medicine, where all parties seek more, not less, information about the safety, effectiveness, and value of treatments, fostering informed communications among all stakeholders is critical.  We are in the midst of a transition to value-based healthcare – a transition that has the potential to improve the efficiency of the overall healthcare system. Earlier this year, BIO and its members endorsed a systemic set of principles and commitments in support of moving us toward a value-based system – the first major healthcare industry association to do so.  

BIO Statement on Biosimilar User Fee Act Goals Letter

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

BIO Applauds Senate Passage of Advancing Hope Act

Washington, D.C. (September 23, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding Senate passage of the Advancing Hope Act of 2016:

SPA: BIO Comments on Special Protocol Assessment; Draft Guidance for Industry

BIO is supportive of FDA’s efforts to clarify the special protocol assessment (SPA) process for sponsors through the updated draft Special Protocol Assessment guidance, which provides helpful clarification on which protocols are eligible for SPA, as well as other updates and details.