Risk Profile: Biotech Industry "Plant-Made Pharmaceutical" (PMP)

5/24/2004

Executive Summary

Biopharmaceuticals are proteins generated in living organisms that have medicinal properties. They were once obtained exclusively from animal or human tissues, such as insulin from pig pancreas or albumin from human blood. Over the past 20 years, biopharmaceutical production has boomed with a shift in production platform from tissue-extraction to fermentation facilities employing genetically engineered animal cells, bacteria, yeast and fungi. With over 120 products, the global market in biopharmceuticals is valued at $41 billion, with growth of over 20% in each of the past five years.

Genetically engineered (GE) plants represent an experimental platform for production of these compounds (i.e. "plant-made pharmaceuticals," or PMPs). Factors driving the use of GE plants include anticipated reduction in production costs, ease of scalability, and storage cost savings vis-à-vis proven fermentation techniques. However, despite 12 years of open-air field experimentation and huge investments of time, money and scientific expertise, not a single PMP has passed FDA's stringent drug review process. PMPs are failing for numerous reasons, including technical difficulties, food industry opposition, increasingly stringent and costly regulation, untenable liability, opposition from farming and consumer groups, and growing interest in alternate production platforms.