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.

This bill changes rules about when generic drugs can be sold. Currently, the first company to apply for approval of a generic drug gets 180 days where only they can sell that generic drug, starting when they actually begin selling it. The bill would let the FDA approve a second company's generic drug application before the first company starts selling, but only if several conditions are met - including that the first company's application has been waiting at least 33 months and the second company promises to start selling within 75 days. If the second company doesn't start selling within 75 days after getting approved this way, their approval becomes temporary and they lose eligibility for future approvals unless they can prove the delay was due to unexpected problems that are now fixed.

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