An overview of the drug approval process

Research Initiative/Treatment Action!, Summer, 2002 by L. Joel Martinez

Why is an Investigational New Drug Application referred to as an "Exemption"?

Persons familiar with FDA workings will often refer to an Investigational New Drug (IND) application as an "exemption" or as an "IND exemption." The use of this terminology can be confusing to the uninitiated. The explanation for the use of this term is simple, but often not given.

The FDA has legal jurisdiction only over products shipped in interstate commerce. States have jurisdiction over products that are manufactured, shipped, and marketed within a state. US law requires that drugs must be approved for marketing prior to shipping over state lines. Since drugs are usually tested in multiple states, sponsors must obtain an exemption from the legal requirement of drug approval prior to shipping their drug to the various out-of-state investigators who are participating in the testing of the drug.

Thus, the IND is not an application for marketing approval even though it usually starts the mechanism towards that approval. Instead the IND is an application for exemption from the legal requirement that drugs be approved for marketing prior to being shipped across state lines. Despite this technical aspect of an IND application, the application is used primarily to obtain evidence that the drug is reasonably safe and that human studies should proceed.