FDA Streamlining of Biopharmaceutical Review A Welcome Development

In response to the FDA’s plan to consolidate reviews of pharmaceutical products, including biologics, at the Center for Drug Evaluation and Research, BIO President Carl B. Feldbaum today issued the following statement:

“Although the details and their full implications have yet to be determined, we are pleased with the Bush administration’s efforts to bring life-saving drugs to patients faster alongside greater consistency in the drug development and review process.

“It is our understanding that therapeutic biologics will continue to be regulated under the Public Health Service Act, and that biologics license applications, and not new drug applications, will continue to be submitted for such products.

“BIO and its members will do everything we can to facilitate this transition toward streamlined development and review of biologics, while upholding the current gold standard of safety and efficacy.

“It is also essential that the FDA ensure the necessary resources and expertise are brought to bear on the biologics under the purview of the Center for Biologics Evaluation and Research, including cell and gene therapy, vaccines, tissues and blood.”

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.

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