Citizen Petitions Are Crucial In Managing A Drug's Life Cycle

Law360 (November 8, 2019, 4:25 PM EST) -- A citizen petition is a tool for petitioning the government which, properly applied, can be used to:

1. Advance the goal(s) of a pharmaceutical company;

2. Gain advantage(s) against a competitor (branded or generic); or

3. Alert the U.S. Food and Drug Administration of a potential public health hazard.

These objectives need not be mutually exclusive. Although we focus here on drugs — prescription and over-the-counter — citizen petitions have been used in other regulated categories such as dietary supplements.

With creativity, clear objectives and a thorough understanding of underlying facts and issues, citizen petitions may be useful with regard to other regulated...

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