While passage of the Continuing Resolution by Congress on September 30, 2022 and corresponding reauthorization of user fees for the different programmatic areas is a relief, the extremely late passage of the Bill leaves FDA and Industry in an awkward position in relation to one of the most important elements of the reauthorization-submission of applications and the associated user fee.
H.R. 6833 found here includes the FDA USER FEE REAUTHORIZATION ACT OF 2022 which, as expected, grants FDA authority to continue collecting user fees from regulated industry. However, the still unanswered question of how is it possible for an application sponsor to remit their application fee when there is no Federal Register Notice publishing the fee amounts, no available user fee cover sheet for Fiscal Year 2023, and FDA’s iStore for submitting payment isn’t open for business? I’m sure that many in Industry have witnessed the Alert copied below from the userfees.fda.gov website:
FDA is awaiting congressional action to provide authority to collect FY 2023 user fees under the Biosimilar User Fee Act (BsUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA) and Prescription Drug User Fee Act (PDUFA) programs. As a result, FDA cannot accept FY23 coversheets for these user fee programs at this time. FDA will announce the FY 2023 user fee rates and payment instructions through Federal Register notices once legislation authorizing FDA to collect user fees for FY 2023 is signed into law.
Considering the contentious negotiations leading up to passage of H.R. 6833, there was no assurance that the CR was going to pass prior to October 1st, so there wasn’t much that FDA could have done in advance. But where does this situation leave applicants that want to submit an application now or in the coming days prior to FDA’s issuance of the FR notice and user fee cover sheet? What about those applicants that may even need to submit an application on a specific date to have an application submitted on an NCE minus one date (NCE-1)? Below are four NDAs with New Chemical Entity Exclusivity that expires between October 1, 2023 and October 8, 2023. Prospective ANDAs which reference two of the four NDAs are eligible for submission between now and the end of this week:
NDA 209521 Seysara- Sarecycline HCL Tablets: NCE expires October 1, 2023.
NDA 208816 Nuzyra- Omadacycline Tosylate Tablets: NCE expires October 2, 2023 but extended by 5 years of GAIN.
NDA 209817 Nuzyra-Omadacyline Tosylate Powder: same exclusivity as Tablet dosage form.
NDA 211172 Tegsedi- Inotersen Sodium Injection: NCE expires October 5, 2023.
ANDAs which reference NDA 209521-Seysara were eligible for submission as of the NCE-1 date of October 1, 2022 and those which reference Tegsedi are eligible for submission on the NCE-1 date of Wednesday October 5th as there are multiple patents listed for both of these NDAs that may serve as the basis of a Paragraph IV certification. Both of the NDAs marketed under the proprietary name Nuzyra are protected by NCE+GAIN which effectively blocks ANDA submissions until October 2, 2027.
Congress’s lack of timely action places this issue on the shoulders of FDA and I’m sure they are working feverishly to address these issues. However, without any definitive statements from FDA regarding when all of the required elements will be available to sponsors to remit their user fee, I think the best advice for ANDA sponsors that wish to secure First Applicant status for an NCE-1 submission would be to submit the application on earliest eligible date and worry about paying the fee as quickly as possible after fees amounts have been established, the cover sheet is available, and payment processing is open. Unlike similar past instances where FDA lacked authority to collect fees due to Congressional inaction, Congress has provided the necessary authority, but not in a timely enough manner for FDA to have taken all administrative actions necessary for a smooth transition into FY 2023.