Several agencies of the U.S. federal government regulate the activities and product introductions of the biotech industry; some have overlapping responsibility. The Food and Drug Administration (FDA) reviews and approves biotech products in the healthcare sector, much like it does for the pharmaceutical industry. The FDA approves the safety of all foods and new food ingredients.
In addition, all producers are required to ensure the safety and quality of anything they introduce into the food supply.
Three major events are shaping the regulatory environment in the biotech healthcare arena. First, in reaction to criticism that it was acting too slowly, the FDA moved the review of biologic drugs from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) in September 2002, thus bringing the review of all human therapeutics under one roof. A major industry group, the Biotechnology Industry Organization (BIO), supported this move and expressed optimism that the review process will be expedited. Second, the appointment of Dr. Mark McClellan as the FDA’s new commissioner in October 2002 filled a two-year vacancy, one which observers noted may have delayed approval of new products. And third, in August 2002, the FDA announced a new plan to improve the quality and safety of manufactured drugs.
Together, these actions will help stem and hopefully reverse the decline in approval of new products and shorten the timeframe needed for approval. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), new product approvals have been declining from 53 in 1996 to 24 in 2001 and timeframes needed for approval grew from 11.7 months in 1998 to 16.4 months in 2001.
In addition, New Drug Applications (NDAs) for New Molecular Entities (NMEs) declined from 43 in 1998 to only 14 in 2003.In addition to rigorous testing, the FDA requires labeling of any food product produced from genetically altered sources, especially when the nutritional composition of the end product has been significantly affected. Any use of a known allergen must also be disclosed on the label.
The U.S. Department of Agriculture (USDA) regulates agricultural products produced by the food industry, setting standards to ensure that new cropscreated through biotechnology techniques are at least as safe and that pesticides and herbicides are at least as effective as those grown conventionally. Over 5,000 field trials have been conducted on over 20,000 plots in the U.S. since 1988.
The Environmental Protection Agency (EPA) oversees growing of plants with pest-protection characteristics and coordinates with the USDA and FDA, using its own statutes, and establishes allowable food residue tolerance levels for any new compounds.
Sources: Biotechnology Industry Organization; Standard & Poor Biotech Industry Survey; Building Global Biobrands
In addition, all producers are required to ensure the safety and quality of anything they introduce into the food supply.
Three major events are shaping the regulatory environment in the biotech healthcare arena. First, in reaction to criticism that it was acting too slowly, the FDA moved the review of biologic drugs from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) in September 2002, thus bringing the review of all human therapeutics under one roof. A major industry group, the Biotechnology Industry Organization (BIO), supported this move and expressed optimism that the review process will be expedited. Second, the appointment of Dr. Mark McClellan as the FDA’s new commissioner in October 2002 filled a two-year vacancy, one which observers noted may have delayed approval of new products. And third, in August 2002, the FDA announced a new plan to improve the quality and safety of manufactured drugs.
Together, these actions will help stem and hopefully reverse the decline in approval of new products and shorten the timeframe needed for approval. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), new product approvals have been declining from 53 in 1996 to 24 in 2001 and timeframes needed for approval grew from 11.7 months in 1998 to 16.4 months in 2001.
In addition, New Drug Applications (NDAs) for New Molecular Entities (NMEs) declined from 43 in 1998 to only 14 in 2003.In addition to rigorous testing, the FDA requires labeling of any food product produced from genetically altered sources, especially when the nutritional composition of the end product has been significantly affected. Any use of a known allergen must also be disclosed on the label.
The U.S. Department of Agriculture (USDA) regulates agricultural products produced by the food industry, setting standards to ensure that new cropscreated through biotechnology techniques are at least as safe and that pesticides and herbicides are at least as effective as those grown conventionally. Over 5,000 field trials have been conducted on over 20,000 plots in the U.S. since 1988.
The Environmental Protection Agency (EPA) oversees growing of plants with pest-protection characteristics and coordinates with the USDA and FDA, using its own statutes, and establishes allowable food residue tolerance levels for any new compounds.
Sources: Biotechnology Industry Organization; Standard & Poor Biotech Industry Survey; Building Global Biobrands
