Regulatory Articles

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.

Concerns about inadequate attention to product quality and adverse events may slow .The re-election of George W. Bush as president and continued Republican control of Congress will shape the healthcare policy agenda for the coming year. Major initiatives to expand healthcare coverage to the uninsured or reform Medicaid are off the administration's priority list, but social security and tax reform may provide additional tax incentives for individuals and small businesses to obtain health coverage and establish health savings accounts.

PHARMACEUTICALS FOR SENIORS

Devine,  .

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

Projections for new and existing biopharmaceutical drugs indicate that demand will soon overwhelm supply.1 New facilities housing cell-culture units can be built, but they require a substantial capital investment and are costly to operate. In response, alternative production systems are being developed. One of the most promising systems incorporates transgenic plants as the expression host.2-5