On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II. There are a number of hidden landmines relative to fee payment, especially relative to the program fee and reminder information about requests to withdraw an ANDA and its impact on the tier designation for the Program Fee, including the dates upon which the new program fees must be paid as well as penalties for non-payment. This 36 page document has some great information and it behooves all generic drug sponsors to read it in detail. The full guidance can be found here.
Just to point out a few things:
Relative to the tier status for program fee assessment, requests for withdrawal of approved applications must be made in a timely manner to assure that the official withdraw may be accomplished prior to the next Program fee assessment date (October 1 of each year). As the FDA guidance notes:
An ANDA shall be deemed not to be approved for purposes of the GDUFA Program Fee if the applicant has submitted a written request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year. If such a request to withdraw an ANDA is made after April 1st, FDA may not be able to withdraw the approved ANDA by the October 1 due date for that fee and the applicant should expect that that ANDA will be counted as approved when determining which tier an applicant and its affiliates are placed.
The document also discusses and outlines the changes to GDUFA II, speaks about the definition and fees associated with contract manufacturing organizations (CMO), covers payment procedures, appeals, API and DMF fee assessments when included in an ANDA rather than a Type II DMF. It notes that there are few if any exceptions to pay ANDA fees and that waivers are generally not available (although CMO pay only one-third of the finished dosage form facility fee).
There is an interesting section describing “serially submitted ANDAs” (those application with a PIV certification submitted multiple on successive days in an attempt to be certain they are first to file on the first available day the patent is listed) even though the regulations actually prohibit such submissions.
This just brushes the surface of the document. There is a lot of “good stuff” in the guidance for industry and each and every firm should assure a complete understanding of the implications and contents of the guidance on owned ANDA, fee structure and appropriate dates for payment as failure to follow the requirement could place either receipt of an application or approval of all pending applications at risk.