UF FDA to decide on forfeiture of 180-day exclusivity for ANDA on case-by-case basis

New Delhi, September 13, 2021:

The US Food and Drug Administration (FDA) has said that its decision on the generic drugs which are eligible for a 180-day exclusivity, which might have impacted by the agency’s inability to conduct certain domestic and foreign inspections during the Covid-19 public health emergency, will be on a case-by-case basis.

The Abbreviated New Drug Application (ANDA) applicant can use a different batch of unexpired reference product to complete BE studies if the batch used in the BE studies expired before the programme can be resumed owing to the Covid-19 public health emergency, said the administration in a revised guidance issued to the industry.

The guidance was issued to address the questions raised by the industry related to the procedures of ANDA which were impacted due to the Covid-19 public health emergency. FDA has updated the guidance, first published in April 2021, in September to answer additional questions regarding the procedures.

The Medicare Prescription Drug, Improvement, and Modernisation Act of 2003 (MMA) describes certain events that can result in the forfeiture of a first applicant’s eligibility for 180-day generic drug exclusivity, including failure to obtain tentative approval within 30 months after the date on which the application is filed. An exception is in place if the failure is caused by a change in or a review of requirements for approval of the application imposed after the date on which the application is filed.

If an ANDA has been determined by the regulatory agency to meet the statutory standards for approval within 30 months after the date of submission, and it is only patent and exclusivity protection that prevents full approval, that applicant will be given a tentative approval and will maintain eligibility for 180-day exclusivity. If the tentative or final approval is not obtained within 30 on this, eligibility for the exclusivity period is generally forfeited subject to certain conditions.

“In making forfeiture decisions, the Agency considers the specific facts and circumstances relevant to the ANDA under consideration. In addition, for certain 180-day exclusivity decisions that require analysis by FDA, including those under the ‘failure to obtain tentative approval’ in 30 months provision, it is FDA’s practice to make these decisions in the context of specific ANDAs that are otherwise eligible for approval,” said the revised document.

“Accordingly, whether FDA’s inability to conduct certain inspections will factor into 180-day exclusivity decisions will be determined on a case-by-case basis,” it added.

Responding to the industry queries on the expiry of test product batches used for BE study due to interruption caused by the Covid-19 pandemic, the Agency said that a prospective applicant for ANDA may use a test product batch that is beyond the current expiration period to resupply its BE studies as long as sufficient evidence can be provided to demonstrate the acceptability of the test product batch. The test batch may be considered acceptable if the submitted stability data meet the drug product shelf-life specifications. If a new test product batch is used, with the same formulation, it should be manufactured using the same equipment under the same conditions and it should be based on the batch size recommendations provided in the guidance for industry.

If the test product batch expires Tweenies in vitro BE studies and in Vigo Pharmacokinetic study, the study can be completed with a new test batch, but the applicant needs to conduct both in vivo PK BE study and in vitrostudies. Use of expired reference products to complete BE studies is not acceptable. Conducting a study in multiple groups in a staggered fashion may be acceptable. PharmaBiz