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 would modify the FDA’s approval pathway for abbreviated new drug applications (ANDAs, i.e., generics) to permit a later applicant to obtain approval and potentially commence marketing even if an earlier first applicant would normally have 180-day exclusivity. It creates a new eligibility framework (subclause III) where, under specific timing and certification requirements, a second applicant may receive effective approval despite the first applicant’s 180-day exclusivity. It also introduces a forfeiture and cure regime: if a later applicant approved under this pathway fails to begin commercial marketing within a 75-day window after approval, the approval can become tentatively or effectively withdrawn, with a mechanism to cure in certain unforeseen circumstances. The provisions apply to applications filed after enactment for listed drugs that had no pre-enactment Paragraph IV certification. In short, the bill seeks to accelerate generic entry in cases where a first applicant delays marketing, by permitting a compliant second applicant to move forward, while imposing enforceable conditions and potential forfeiture if marketing does not commence as required.
Key Points
- 1New pathway for later applicants: The Secretary may approve an ANDA for a drug even if a first applicant has submitted a certification and might be eligible for 180-day exclusivity, provided a set of conditions is met (including that first-applicant exclusivity would otherwise block the second’s effective approval).
- 2Specific conditions for approval under the new pathway:
- 3- Approval could be made effective but for the first applicant’s 180-day exclusivity.
- 4- The second applicant must certify that there are no conditions preventing marketing within 75 days after approval and that it intends to market.
- 5- At least 33 months must have passed since a first applicant submitted an application for the drug.
- 6- Approval of at least one first applicant must not be precluded.
- 7- No first-applicant drug can be effectively approved while these conditions are met and maintained.
- 8Special forfeiture and cure rules for subsequent applicants:
- 9- An approval granted under the new pathway is deemed tentatively approved and can lose its effectiveness after a 75-day marketing window if the applicant fails to commence marketing.
- 10- The applicant may cure by notifying FDA if it cannot market within the 75-day period due to an unforeseen event, but otherwise may lose eligibility for subsequent “effective approval” unless it also certifies the unforeseen event and resolution.
- 11- If not marketing within the 75 days and without cure, the applicant may be ineligible for another effective approval for that drug unless it meets additional conditions and certifies unforeseen events and resolutions.
- 12Applicability: The amendments would apply to applications filed after enactment that identify a listed drug for which no pre-enactment Paragraph IV certification was made.