H.R. 1051 — To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

H.R. 1051 — To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. | JustPolicyThe purpose of this legislation is to modify the rules surrounding the approval of generic drugs in the United States. Specifically, it aims to streamline the process for subsequent applicants to gain approval for their generic drugs if the first applicant fails to start selling their product within a specified timeframe. Key provisions of the legislation include a new rule that allows a second applicant to receive approval for a generic drug even if the first applicant has not begun commercial marketing.