Envision a time in the near future where pharmaceutical treatments for some of mankind’s most life-threatening illnesses—cancer, diabetes, hepatitis, HIV, Alzheimer’s and heart disease—are not only produced efficiently and cost-effectively, but made readily available to people around the globe. This promising scenario is emerging into reality as a result of research, field trials and clinical testing by companies in the plant-made pharmaceutical (PMPs) industry.

PMPs are therapeutic proteins produced by incorporating antibodies into the genetic make-up of plants. In turn, plants become “factories,” producing proteins that are extracted, refined and used in typical pharmaceutical applications.

Because PMPs are vastly different than traditional commodity agriculture, they are grown under highly regulated conditions by the U.S Department of Agriculture (USDA) and the Food and Drug Administration (FDA). Furthermore, within these agencies are additional groups that monitor PMPs, such as the USDA’s Biotechnology Regulatory Services (BRS) and the Animal and Plant Health Inspection Service (APHIS); and the FDA’s Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). All of these agencies help to ensure that the production and handling of pharmaceutical-containing plants are managed safely for humans and the environment.

Among the many monitoring responsibilities for regulatory agencies is to make sure PMPs are grown and processed separately from other crops. This procedure is called “Confinement.” Depending on the unique characteristics of the crop being planted, confinement may include spatial isolation and temporal separation. APHIS directives require certain distances between PMP fields and fields for standard, food and feed crops. And, the time when conventional crops flower and pollinate is separated by APHIS regulations from the time PMP crops flower and pollinate.

Confinement practices, along with numerous related efforts involved in growing PMPs, are conducted under special USDA and FDA permits. Permits are issued on an individualized basis and involve both federal and state agricultural department approvals. The permit process, which generalyl takes 120 days for approval or denial, involves specific documentation that address dedicated equipment, farm worker safety and training, controlled pollination procedures, harvesting, handling, shipment and storage. Both criminal and civil penalties may be invoked in the event a permit is violated.

By 2010, the potentially rich markets for plant-grown medicines are predicted to become a $20 billion industry. This promising future, though, is dependent on the success of both biotechnology companies and regulatory agencies. Continued policy refinement, maintaining USDA and FDA regulations, and working to protect consumers and the ecosystem will allow the benefits of this business to unfold.