WASHINGTON, D.C. (Monday, April 20, 2009) - In testimony submitted today to the National Institutes of Health (NIH), the Biotechnology Industry Organization (BIO) stressed the commitment of its member companies to help ensure that patients and health care providers have access to key clinical trial results information from trials of unapproved products.
“BIO supports efforts to increase the availability of accurate, reliable, scientific evidence to inform clinical decision-making,” stated BIO President and CEO Jim Greenwood. “We believe that individual patients, clinical decision-makers and scientific researchers should be armed with the best available information to help assess the relative clinical benefits and risks of treatment options.”
The Food and Drug Administration Amendments Act (FDAAA) directs NIH to address whether or not results of clinical trials should be disseminated if the drugs studied in the trial are unapproved. BIO's testimony today was part of a public meeting required to be held to address this and other questions regarding public disclosure of clinical trial results.
In testimony, BIO reiterated its support for FDAAA’s goal to, “provide more complete results information and to enhance patient access to and understanding of the results of clinical trials.” BIO noted that disseminating certain additional trial result information may reduce duplicative studies, which divert industry resources that could be used to undertake innovative research, and could also alleviate pressures on the Food and Drug Administration’s review resources.
BIO urged the agency to ensure that data provided on ClinicalTrials.gov has scientific merit and can enhance the treatment and safety of patients. BIO also asked the NIH to consider carefully new requirements for the expansion of the public database so such requirements are not overly burdensome, especially for small, minimally-staffed biotechnology companies. The requirements should ensure that the information released is useful, understandable, and will best serve the public interest.
BIO’s testimony is available at http://www.bio.org/healthcare/BIO_Comments_NIH_2009_0002.pdf.
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BIO represents more than 1,200 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.