George A. O'Brien
George O'Brien works with innovative pharmaceutical and biotech companies on lifecycle management issues. He's probably best known for his substantial experience with orphan drug designation and exclusivity matters. In particular, George helps clients avoid the pitfalls that can delay an orphan designation or award of orphan exclusivity, such as issues related to prevalence, orphan subsets, and clinical superiority. When clients must resolve a dispute with an agency over orphan issues, George's comprehensive knowledge of relevant precedent is a valuable tool.
George assists companies at all stages of product development to maximize their FDA regulatory exclusivities, including Hatch-Waxman, orphan drug, and pediatric exclusivities. Drafting citizen petitions is a key part of his practice, and he's collaborated with other organizations to create drafts on a wide range of issues, including bioequivalence and approval requirements for generic products, the operation of 180-day exclusivity, therapeutic equivalence issues, and new chemical entity exclusivity.
George serves as a member of the Food and Drug Law Institute's Drugs and Biologics Committee.
Areas of Focus
Submitted citizen petition convincing FDA to recognize five-year "new chemical entity" exclusivity for certain fixed-dose combination products.
Represented Depomed, Inc. in regulatory proceedings and federal litigation regarding orphan drug designation and exclusivity.