US FDA sets up board to review drug exclusivity decisions

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has established an Exclusivity Board to improve the clarity and consistency of decisions granting drug market exclusivity. The Board will review selected cases involving five-year new chemical entity exclusivity, three-year clinical investigation exclusivity and biological products, including disputes over eligibility and the scope of protection. Exclusivity can delay competing products from entering the market. More consistent decisions can help drug developers understand the scope of their protection and help generic manufacturers assess when competition may be possible.