(WASHINGTON, DC, November 10, 1997)...Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), today issued the following statement in response to Congressional passage of legislation which reauthorizes the Prescription Drug User Fee Act (PDUFA) and modernizes the Food and Drug Administration (FDA).
Passage of this legislation today `turns the clock ahead' to help the next generation of modern medicines get to patients sooner and more efficiently. Several hundred biotech products are in clinical trials right now at the FDA, many for medical conditions such as Alzheimer's and breast and ovarian cancers, for which there are no adequate treatments. With this bill we have achieved a regulatory process for the beginning of the next century that recognizes both the advances in our technology and the need to bring biotech products to the market, and even more critically to patients as soon as possible. Passage of this bill also represents a new, successful partnership between our biotech industry researchers and government regulators at the FDA. Instead of an adversarial or even confrontational posture in which both our research companies and patients lose, this bill represents over two years of negotiations which will result in the ability of biotechnology companies to more efficiently develop their scientific breakthroughs into vital medical products. Put simply, a modern FDA will greatly enhance our industry's potential to develop new therapies and cures. "This legislation, which also reauthorizes PDUFA, will provide resources for additional drug reviewers and an electronic FDA. In addition, it helps cut the red tape on clinical trials by modernizing several 35-year-old FDA regulations. For example, the manner by which manufacturing changes are reported to the FDA will be streamlined, greatly reducing bureaucratic impediments against improving manufacturing processes. In very human terms this legislation means renewed hope for millions of patients, and their families, who suffer from heart disease, various cancers, cystic fibrosis, multiple sclerosis and other debilitating and deadly diseases. "We call upon President Clinton to sign this legislation with all deliberate speed."
The Biotechnology Industry Organization (BIO) represents over 745 biotechnology companies, academic institutions, and state biotechnology centers in 46 states and 25 nations. BIO members are involved in the research and development of health care, agricultural and environmental biotechnology products.