BIO Looks Forward to Implementation of FDA Reforms

WASHINGTON, D.C. (November 21, 1997) _ Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO) today issued the following statement after a White House ceremony at which President Clinton signed into law the Food and Drug Administration Modernization Act of 1997.

"Although FDA reform legislation was signed into law today, the product of almost three years of intensive negotiations, the greater challenge now for industry and government is to work together so that these new provisions achieve their maximum intended effect.

"Having worked so hard to get these innovations signed into law, BIO will be even more determined to make sure that implementation is rigorous and thorough.

"With full implementation, a modernized FDA will greatly enhance our industry's ability to develop new therapies and cures. BIO welcomes the opportunity to play an active role with FDA to develop new regulations and guidance documents. The beneficiaries of full cooperation will be the millions of patients, and their families, who await effective treatments for Alzheimer's, AIDS, cancer, heart disease and other debilitating and deadly diseases."

Feldbaum also praised Vice President Gore's efforts. "The Vice President's Reinventing Government Program resulted in important administrative changes and lent momentum to the FDA reform process.

"We're pleased to open an era of greater partnership between industry researchers and government. The law, which also reauthorizes PDUFA, will provide resources for additional drug reviewers at FDA and for electronic submissions to the agency. Importantly, it revises the clinical evidence standard, putting in place more effective efficacy standards for biologics and drug approvals. In further streamlining, the law establishes criteria for fast-track status and removes bureaucratic impediments for companies to improve manufacturing processes."

BIO represents over 745 biotechnology companies, academic institutions and state biotechnology centers in 46 states and 25 countries. BIO members are involved in research and development of health care, agricultural and environmental biotechnology products.