Accelerating New Pharmaceutical Competition Act
This bill amends the Federal Food, Drug, and Cosmetic Act to permit brand name drug applications to rely upon investigations conducted in certain foreign countries if the drug has been approved in the foreign country where the investigations were conducted. The Food and Drug Administration (FDA) has 90 days to act on these applications.
The bill revises a provision regarding the effective date of the approval of a generic drug that is subject to a patent infringement action.
The FDA must prioritize the review of, and act within 150 days on, generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.
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