Date: Thursday, November 9,1995
FOR IMMEDIATE RELEASE
Contact: FDA Press Office (301) 443-3285

Reinventing Regulation of Drugs Made
from Biotechnology

The Food and Drug Administration today is proposing several measures that will reduce costs for manufacturers of biotechnology derived pharmaceuticals, increase the agency's efficiency and continue to protect the public health. The six proposals -- which constitute FDA's most significant overhaul of biotech regulations to date -- complement and build on the drug and medical device reforms announced last spring as part of the Clinton Administration's National Performance Review.

"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:

• Elimination of establishment license application (ELA) for well-characterized therapeutic biotech drugs.

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.

• Elimination of FDA's lot-by-lot release for well-characterized therapeutic biologic drugs that are licensed for marketing.

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.

• Consolidation of 21 different approval application forms into a single, user-friendly format.

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.

• Elimination of the need for approval of promotional labeling before launching a new product.

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.

• FDA commitment to review and respond within 30 days to information submitted in response to a clinical hold on a study of an investigational drug or biologic.

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.

• Revision of the manufacturers' requirements to appoint a "responsible head" for compliance and official contacts with FDA.

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 U.S. biotech industry comprises about 1,300 mostly small-to-medium-size companies, which explore new approaches to the diagnosis, prevention, treatment and cure of life-threatening and seriously debilitating diseases.

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.

###