US Regulation of Plant-made Biopharmaceuticals, Part 2

The evaluation, production, and distribution of therapeutic products derived from recombinant plants are regulated under existing laws administered by FDA, USDA, and EPA.

In the first part of this feature (Jan. 2005) we discussed the technical background and the role that FDA, US Department of Agriculture (USDA), and Environmental Protection Agency (EPA) play in setting the rules for accepting plant-made biopharmaceuticals (PMBs). We now continue by discussing how producers will be able to take products to market.

GUIDANCE FOR INDUSTRY

There are six important issues to consider when filing an Investigational New Drug (IND) Application for a PMB. We will examine them here.

 Agency Overlap.

 FDA and USDA issued "Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals," in September 2002.34 This guidance resulted from collaboration between FDA and USDA and outlines the regulatory expectations for products derived from bioengineered plants. It describes the division of authority between the two agencies and also provides technical guidance on the use and characterization of the plants and the products produced from them. The document is still in draft form but provides an idea of FDA and USDA concerns. Issues addressed in the guidance are shown in Table 2. (Table 1 is in Part 1). Note the high degree of overlap between FDA and USDA issues.

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