Combination Drug Development Incentive Act of 2015

Combination Drug Development Incentive Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to provide a five-year marketing exclusivity period to a new drug approved by the Food and Drug Administration that is a novel combination of active ingredients. The application for the combination drug must contain reports of new clinical investigations that are essential to approval and were conducted or sponsored by the applicant. Currently, a new drug that includes an active ingredient that has already been approved is provided a three-year marketing exclusivity period.