To Switch or Not to Switch? GRAS/GRAE is Still the Question

Abstract

In the 1938 Act, the Congress clearly had in mind a system under which a drug would move over time from new to GRAS/GRAE. The reasons that the movement is slow, sporadic, and inconsistent involve the opposing forces acting consistently with their natures. The FDA resists relinquishing authority where it feels it may want it in the future. The companies that have obtained premarket approval are totally resistant to the notion that competitors might not have to overcome the same barriers. As a result, the inertia of these combined forces can be formidable opposition to the desired movement of Rx drugs to general recognition status. Nevertheless, the expectations and presumptions of the law are clear that drug products should move over time to GRAS/GRAE status. Unless there are further fundamental changes in the law, the dynamics of competition will make GRAS/GRAE citizen's petitions and declaratory judgment actions more important to the Rx-to-OTC switches of the next decade. The base proposition for many of these actions can only be that threshold question: “Has GRAS/GRAE status finally arrived?”