This document was downloaded and archived from http://www.os.dhhs.gov/news/press/1995pres/951109.html on June 1st, 2001.
Date: Thursday, November 9,1995
FOR IMMEDIATE RELEASE
Contact: FDA Press Office (301) 443-3285
"Biotechnology holds great promise for American patients. These reforms will help industry deliver on those promises while maintaining the Food and Drug Administration's critical role in protecting the American people," said Vice President Gore.
The Vice President also announced the release of a report by the National Science and Technology Council, "Biotechnology for the 21st Century: New Horizons," which describes the federal investment in biotechnology and identifies research priorities and opportunities for the future.
Two of the most far-reaching FDA modifications apply to well-characterized, therapeutic biotechnology-derived drugs, a product category that includes most biotech drugs.
The United States biotech drug industry has estimated that the proposed changes will cut drug development time by months, reduce the required paperwork by thousands of pages, and save the companies millions of dollars. None of the proposed changes will diminish the safety and effectiveness of the industry's products.
The proposals include the following changes:
Impact: Firms developing and manufacturing these products will be spared the cost of preparing ELAs, some of which may be lengthy and elaborate. FDA will save review time.
Impact: Significant savings of time and resources for the industry. The agency will monitor companies' compliance with the requirement that they release only lots that have been tested and found to be acceptable.
Impact: Manufacturers should save time and be able to prepare higher quality submissions. The agency should be able to expedite the application review and use the standard format as a basis for electronic submissions.
Impact: Industry will no longer need to wait for FDA's approval of promotional labeling before disseminating it, and FDA will save resources for other activities.
Impact: The measure will prevent unnecessary delays of the clinical trials because the agency's failure to respond within the time limit will automatically terminate the hold, and the investigation will be able to proceed.
Impact: Firms will be able to divide management responsibility among appropriate regulatory, medical or manufacturing staff. These individuals will be able to communicate directly with the agency on official matters related to their company's biological products.
The industry has developed all of the two dozen biotech drugs on the U.S. market today, and exports about $1 billion worth of these products each year. More than 450 biotech drugs are being tested by U.S. biotech companies in humans for diseases for which there are no satisfactory therapies, such as cancer, AIDS, and arthritis.
Recognized as the world's leader in its field, the U.S. biotech industry employs more than 100,000 skilled workers, and last year invested $8 billion in research and development.
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