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.

HR 1051 amends the Federal Food, Drug, and Cosmetic Act to allow generic drug manufacturers (subsequent applicants) to receive drug approval if the first applicant fails to begin commercial marketing within 33 months of their application. The bill requires subsequent applicants to certify they can start marketing within 75 days of approval and mandates that they begin marketing within that window or lose their approval. If marketing is delayed due to unforeseen events, applicants must provide specific certification to regain approval eligibility. This directly affects generic drug companies seeking to enter the market after a brand-name drug's exclusivity period lapses.