drugs U.S.

In 2002, ProdiGene was fined $250,000 and ordered by the USDA to pay over $3 million in cleanup costs after allowing a fraction of a bushel of volunteer pharm corn to comingle with the soybean crop later planted in that field. Although the chance of gene flow between species is claimed to be low and there was in this case no threat to consumers, the USDA has a zero tolerance policy. ProdiGene has since revised its protocols and resumed operations in Nebraska. In 2005, Anheuser-Busch threatened to boycott rice grown in Missouri because of plans by Ventria Bioscience to grow pharm rice in the state. A compromise was reached, but Ventria has withdrawn its 2006 permit to plant in Missouri due to unrelated circumstances. The company's field trials in North Carolina are expected to continue. Expression in the milk of a genetically-modified goat was ATryn, but marketing permission was blocked by the European Medicines Agency in February 2006.[2] This decision was reversed in June 2006 and approval was given August 2006.[3] Biopharm proponents claim that using plants can offer an easily controllable, safe, and cost-effective method for manufacturing proteins, provided that proper regulatory safeguards are put into place to ensure that no outcrossing can occur. It is also important to note, that the global demand for particular pharmaceutical protein can easily be met from just a few acres of pharma-crop, which can be grown under high containment conditions (e.g. in the greenhouse)..

Navigation

biosimilars
biotechnology
competitive
drugs U.S.
FDA
generic
generics
intelligence
licenses
licensing