Health Care

April 14, 2016

Resources and Information about the Zika Virus...

December 1, 2014

For more than a decade, BIO has called for open, transparent, and science-based dialogue...

March 25, 2014

The member companies of the Biotechnology Industry Organization (BIO) are committed to...

March 18, 2014

While BIO does not comment on individual companies or their decision-making in regards to...

Letters, Testimony & Comments

April 17 2016
BIO member companies are committed to improving human health through the development of innovative therapies. We strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing our clinical trial data can help to advance such research, while reinforcing public confidence in the safety and efficacy of our medicines.
April 4 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit comments in response to the Centers for Medicare & Medicaid Services’ (CMS’s) Final Rule with Comment entitled Medicaid Program; Covered Outpatient Drugs Final Rule with Comment Period (the “FC”).1 As directed by the Agency, the scope of our comments is limited to the single topic open for public comment: “The definition and identification of line extension drugs.”2 
March 13 2016
BIO strongly supports efforts by the Agency, such as the Pilot COA Compendium and recent updates to the FDA’s drug development tool (DDT) qualification website, to promote the efficient development and use of COAs and other DDTs for drug development and regulatory decision-making. We believe that the COA Compendium is a good step in providing information to the public about COAs in development and use, providing a level of transparency and increasing awareness of efforts towards patient-focused drug development and COA information.
February 16 2016
BIO supports FDA’s assertion that “it is critical for sponsors to detect and report, as early as possible, serious and unexpected suspected adverse reactions and clinically important increased rates of previously recognized serious adverse reactions,” and we appreciate the publication of this Draft Guidance to aid Sponsors in this responsibility. However, we are concerned about the prescriptive nature of this Draft Guidance and its emphasis on the Safety Assessment Committee (SAC). We are also concerned that FDA may not fully appreciate the time and resources required of Sponsors to implement the recommendations within the Draft Guidance.
February 8 2016
BIO strongly supports the Prescription Drug User Fee Act (PDUFA 5) program to enhance FDA-Sponsor communication, which is based on FDA’s stated philosophy that “timely interactive communication with Sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.” BIO applauds FDA’s effort to give IND Sponsors and FDA review staff best practices and procedures for timely, transparent, and effective communications during drug development through this Draft Guidance.

Press Releases

April 25 2016
Washington, D.C. (April 25, 2016) – The Biotechnology Innovation Organization (BIO) issued the following statement today regarding the Campaign for Sustainable Rx Pricing’s policy proposals on prescription drug prices:
April 6 2016
Washington, D.C. (April 6, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding today’s Senate HELP Committee mark-up of legislation as part of the Senate biomedical innovation initiative:
March 30 2016
Washington, D.C. (March 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding the American College of Physicians’ policy paper on prescription drugs:
March 17 2016
Washington, D.C. (March 17, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the introduction today by Senators Alexander and Murray of the FDA and NIH Workforce Authorities Modernization Act: