(Michael J. Werner, Director of Federal Government Relations/Bioethics Counsel for the Biotechnology Industry Organization (BIO), issued the following statement today regarding the Dept. of Health and Human Services announcement regarding oversight of human clinical trials.)
WASHINGTON, D.C. (May 23, 2000)The biotechnology industry supports the recommendations of the Department of Health and Human Services to assure the well-being of patients involved in all clinical trials to develop new drug and gene therapies.
The importance of these patient trials in finding cures for ‘untreatable’ diseases cannot be underestimated. Just last month researchers in France reported successful treatment of infants born with a life-threatening immune system disorder that are now healthy and living normal livesthe direct result of treatment with gene therapy.
These new guidelines will be instrumental in ensuring the continued confidence and trust patients and their families have placed in the researchers and institutions working to find therapies to relieve their illnesses.
We will work closely with the Department of Health and Human Services in the development and implementation of these guidelines to ensure that the intent and goals of these important recommendations are fulfilled.
BIO represents more than 920 companies, academic institutions and biotech centers in 47 states and 26 nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental products.