Get Your Priorities Straight

The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry.

Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission facility correspondence) related to the priority submissions were labor intensive. Also, to reap the fruits of priority review, it is important for the sponsors to be ready for the fast-moving process. One option is to perform detailed gap analysis of the ANDA, maybe right after submission, to make sure that deficiencies are identified, and the remediation process started. That way, by the time the IRs and DRLs are issued by FDA, sponsors are ready with their responses. It was also pointed out that priority reviews maybe more beneficial for major amendments and prior approval supplements, something that the industry often overlooks. The panel further want on to point out that when a drug in the priority list is eligible for CGT (competitive generic therapy) designation, the request for this designation should be made prior to the submission of the ANDA. A good time for making the request is when the PFC is being submitted. The panel members talked about using good judgment in selecting priority ANDAs. It was highlighted that a priority product is worth developing when the sponsor has the confidence that they may get a first cycle approval or at the most need to respond to a minor CRL. For this, the state of the original submission needs to be pristine. In addition, the facility should not have any pending compliance issues.

Panelist also pointed out that one of the biggest challenge to first cycle approvals of priority ANDAs may be issues related to Type II DMFs for APIs. The ANDA sponsors should be judicious in selecting the API supplier to make sure that the DMF related deficiencies are not an impediment to the ANDA approval. Two major issues related to APIs which could result in significant delays in approval of ANDAs are redefinition of the regulatory starting material and inadequate information related to genotoxic impurities.

The panel generally agreed that the submission of priority ANDAs are resource intensive and generic companies should apply their judgment to decide which priority products may be right for them. After all, prioritizing everything amounts to prioritizing nothing. However, the discussion ended in a positive note as the industry felt optimistic with the recent approval of the first CGT ANDA.