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.

This section revises the 180-day exclusivity provisions for abbreviated new drug applications under 21 U.S.C. § 355(j)(5)(B)(iv) by authorizing the Food and Drug Administration (FDA) to approve a subsequent applicant’s application, notwithstanding a first applicant’s eligibility for 180-day exclusivity, if the subsequent applicant’s application contains a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), the application could otherwise be made effective, the applicant certifies it can begin commercial marketing within 75 days of approval and intends to do so, at least 33 months have elapsed since at least one first applicant submitted an application, approval of a first applicant is not otherwise precluded under 21 U.S.C. § 355(j)(5)(B)(iii), and no first applicant has an effective approval on the date those conditions are met. This section also establishes a special forfeiture rule for such subsequently approved applications, under which the application is deemed tentatively approved and loses effective approval beginning the day after the 75-day marketing period if the applicant does not begin commercial marketing, with a cure process allowing the applicant to notify FDA that it cannot meet the 75-day deadline and, if it later seeks effective approval again, to certify that an unforeseeable event prevented marketing and that the problem has been fully resolved. This section further requires an applicant that begins marketing after using the cure process to notify FDA within 1 business day. This section applies only to abbreviated new drug applications filed after enactment that identify a listed drug for which no certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) was made before enactment.