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BIO Statement on FDA Product Communications Hearing

November 9, 2016

Washington, D.C. (November 9, 2016) – Biotechnology Innovation Organization (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.

“Harnessing the full potential of value-based healthcare will require that biopharmaceutical companies are able to provide comprehensive, balanced, and scientifically robust information about the medicines they research and develop with all parties who make prescribing and coverage decisions, including physicians and payers. Unfortunately, current FDA regulations can pose significant barriers in this process. We are pleased that the Agency is undertaking a comprehensive review of its regulations and policies governing product communications.

“Recognizing the unique role biopharmaceutical companies have to play in discovering and disseminating information about their medicines, earlier this year BIO and PhRMA released joint Principles on Responsible Sharing of Truthful and Non-Misleading Information, which are intended to form the basis for defining new and clear regulatory standards in this area.

“We look forward to participating fully in this process and hope that the FDA will act swiftly to implement a regulatory framework that encourages the sharing of appropriate, science-based information to ensure that the right patient gets the right medicine at the right time.”


About BIO

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

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