The FDA is moving against DESI drugs and DESI producers are wondering if their products are next on the chopping block. Here are a few commonly asked questions about how that will affect DESI producers.

Will a 505(b)(2) of a DESI receive exclusivity?

Yes, the source of an NDA is not the determining factor in granting exclusivity to an NDA. Any NDA, 505(b)(1) or (b)(2) can be granted 3 years exclusivity for an NDA that requires a clinical study or 5 years exclusivity for a new chemical entity; there are a lot of NCE DESI candidates.

How long after an NDA is approved will it take for the FDA to remove the competing unapproved products?

We don’t know. There are no guarantees that it will eliminate the competitors, but its policy guide indicates it should.

Do DESI NDAs fall under PDUFA?

Yes, all NDAs are subject to user fees. PDUFA allows for no fee for the 1st NDA from a small business (defined as less than 500 employees).

Aren’t PDUFA fees excessive for DESI companies that wish to file an NDA for several products?

PDUFA provides for a full or partial waiver for the fee when an economic case can be made.

Is there a list of DESI products?

No list is available. Most people don’t distinguish between a DESI that went through the review process and those that haven’t yet been reviewed or are identical, related or similar to an approved or pending DESI. A review of the Federal Register from 1966-1969 can get a ‘list’ of products that were reviewed, but the ultimate decision of the review is hard to locate. zof the initial 30 drug categories, 20 still have not been fully completed.

How do you determine a budget for a DESI NDA?

The best way is to conduct an assessment study and then present the gap analysis to the FDA to obtain the agency’s concurrence. The assessment study reviews the public domain and develops arguments why selected data can be used for pivotal information in an NDA. Using what is known from the approval of similar drugs, the gap (the studies needed by the sponsor) is established, and the cost and duration of each study is estimated. This study is then wrapped into a submission for a pre-IND meeting where we also list questions for the FDA to address. After the pre-IND meeting, a sponsor will know what the requirements will be. For assistance in conducting a gap analysis, contact Premier Consulting.