Health Care

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

A report by Health Advances found that significant limitations in the current reimbursement system for novel diagnostics lead to inconsistent coverage decisions and impede the investment necessary for the development of the next generation of diagnostics.

Sara Radcliffe, BIO Executive Vice President Health, presents an overview of BIO's commissioned study on Diagnostics Reimbursement at the Harvard Medical Center Partners Healthcare Personalized Medicine Conference: Impacting Healthcare.

A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.

In this presentation, BIO urges the Food and Drug Administration to prioritize patient safety and incentives for innovation at a public hearing on biosimilars.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

From genetic testing to earlier cancer diagnosis, to rapid result strep tests and diagnostic tools that can be used outside of a traditional hospital environment, biotechnology researchers are making great strides in the field of ddiagnostic tools.

On April 8, 2004, Genentech, Inc. filed a Citizen Petition with the Food and Drug Administration (FDA), requesting that the agency refrain from (1) publishing a draft guidance document setting forth standards for so-called follow-on or "generic" biotechnology-derived products, and (2) approving an application filed under section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA) with respect to a biotechnology product that relies, directly or indirectly, on trade secret and confidential commercial data and information of an innovator.

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: