Ever since the forfeiture provision related to 180-day exclusivity as it relates to the requirement that firms receive approval or tentative approval within 30 months from receipt of an ANDA, there has been some industry confusion regarding the exception of a “change in requirements” and how that might toll the 30-month provision. Kurt Karst provides some insight into a recent case in his FDA Law Blog (here) that may shed some light on the situation.
Firms have asked about when or if tolling takes place, and to my knowledge, there has not been a general answer that I am aware of until now. In an FDA memo related to an exclusivity decision, which is cited in the same post referenced above, the FDA notes:
“If tentative approval or approval is not obtained within 30 months, eligibility for 180-day exclusivity is generally forfeited unless “the failure [to obtain an approval] is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.” Under this provision, it is not sufficient to show that FDA’s review of the ANDA (to determine that the ANDA has met the pre-existing approval requirements), caused a failure to obtain a tentative approval or approval at 30 months. Nor is it sufficient for an applicant to show that FDA changed or reviewed (i.e., considered whether to change) the requirements for approval while the application was under review. The applicant must also show that its failure to obtain a tentative approval at the 30 month date is caused by this change in or review of approval requirements. FDA generally will presume that the failure to obtain tentative approval or approval was caused by a change in or review of approval requirements if, at the 30 month date, the evidence demonstrates that the sponsor was actively addressing the change in or review of approval requirements (or FDA was considering such efforts), and these activities precluded tentative approval (or approval) at that time. Where the evidence fails to demonstrate that the sponsor was actively addressing the change in or review of approval requirements, and these activities precluded tentative approval (or approval) at the 30-month date, FDA generally does not presume that the failure was caused by a change in or review of approval requirements. If FDA were to hold otherwise, an applicant that receives one or more deficiencies resulting from a change in approval requirements could simply delay addressing those deficiencies and avoid forfeiture.” (emphasis added)
I believe that this last sentence relative to the firm actively addressing the issue or active FDA review of the amendment related to the “change in requirement” is key in deciding when or if the tolling of the 30-month requirement will be recognized. It, therefore, appears to be incumbent of an ANDA sponsor to demonstrate to FDA that they are actively addressing a response to the “changed” or “new” requirement during the time period after the requirement is made known to the sponsor. Firms may consider developing a paper trail that documents their action, in that regard, to help support a positive finding by FDA.