This article provides an overview of the US Food and Drug Administration's (FDA's) citizen petition process as it relates to the drug industry and highlights several key issues raised by this process. The authors focus on 505(q) and discuss its potential implications. Introduction FDA regulations provide for a citizen petition process enabling the public to request FDA to take or refrain from taking a certain action. The citizen petition process also is used to bring ot...

This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...