As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices. In this context, ProPharma would like to bring attention to these updates for our clients, colleagues, and contacts.
Given that most user fee updates entail fee increases, now is an opportune time for all FDA-regulated companies to assess their eligibility for user fee waivers or discounts. A common example: drug sponsors with FDA Orphan Drug Designations qualify for a PDUFA fee waiver. Specifically, NDAs (New Drug Application) and BLAs (Biologics License Applications) associated with development programs that have received Orphan Drug Designations are exempt from PDUFA fees unless the NDA/BLA includes an indication other than the rare disease or condition addressed in the Designation. To be eligible for the exemption, the drug sponsor must also have received less than $50 million in gross worldwide revenue during the year prior to requesting for the exemption. It's important to note that this represents just one instance among several potential opportunities for fee waivers and discounts, all of which merit consideration. The table below summarizes some of the key fee updates for Fiscal Year 2023.
Key Highlights
|
FDA User Fee Type
|
FY2023 Fee Rate
|
FY2023 Fee Rate
|
| Prescription Drug User Fee Amendment (PDUFA VII) |
| Application requiring clinical data |
$3,242,026 |
$3,117,218 |
| Application not requiring clinical data |
$1,621,013 |
$1,558,609 |
| Program Fee |
$393,933 |
$369,413 |
| Generic Drug User Fee Amendment (GDUFA III) |
| Abbreviated new drug application (ANDA) |
$240,582 |
$225,712 |
| Drug Master File (DMF) |
$78,293 |
$74,952 |
| Facility: |
| Active pharmaceutical ingredient (API) – Domestic |
$37,544 |
$42,557 |
| API – Foreign |
$52,544 |
$57,557 |
| Finished dosage form (FDF) – Domestic |
$213,134 |
$195,012 |
| FDF – Foreign |
$228,134 |
$210,012 |
| Contract manufacturing organization (CMO) – Domestic |
$51,152 |
$65,004 |
| CMO – Foreign |
$66,152 |
$80,004 |
| GDUFA program: |
| Large size operation generic drug applicant |
$1,620,556 |
$1,536,856 |
| Medium size operation generic drug applicant |
$648,222 |
$614,742 |
| Small business operation generic drug applicant |
$162,056 |
$153,686 |
| Biosimilar User Fee Amendment (BSUFA III) |
| Initial biological product development (BPD) |
$47,325 |
$57,184 |
| Annual BPD |
$47,325 |
$57,184 |
| Reactivation |
$94,650 |
$114,368 |
| Applications requiring clinical data |
$1,746,745 |
$1,746,745 |
| Program |
$304,162 |
$304,162 |
| Medical Device User Fee Amendment (MDUFA V) |
| Premarket approval (PMA) or Biologics License Application (BLA) standard fee |
$441,547 |
$374,858 |
| Premarket approval (PMA) or Biologics License Application (BLA) small business fee |
$110,387 |
$93,714 |
| Premarket report standard fee |
$441,547 |
$374,858 |
| Premarket report small business fee |
$110,387 |
$93,714 |
| Efficacy supplement to an approved BLA standard fee |
$441,547 |
$374,858 |
| Efficacy supplement to an approved BLA small business fee |
$110,387 |
$93,714 |
| Panel-track supplement standard fee |
$353,238 |
$281,143 |
| Panel-track supplement small business fee |
$88,309 |
$70,286 |
| De novo classification request standard fee |
$132,464 |
$112,457 |
| De novo classification request small business fee |
$33,116 |
$28,114 |
| 180-day supplement standard fee |
$66,232 |
$56,229 |
| 180-day supplement small business fee |
$16,558 |
$14,057 |
| Real-time supplement standard fee |
$30,908 |
$26,240 |
| Real-time supplement small business fee |
$7,727 |
$6,560 |
| 510(k) standard fee |
$19,870 |
$12,745 |
| 510(k) small business fee |
$4,967 |
$3,186 |
| 30-day notice standard fee |
$7,065 |
$5,998 |
| 30-day notice small business fee |
$3,532 |
$2,999 |
| 513(g) request for classification information standard fee |
$5,961 |
$5,061 |
| 513(g) request for classification information small business fee |
$2,980 |
$2,530 |
| Annual fee for periodic reporting on a Class III device standard fee |
$15,454 |
$13,120 |
| Annual fee for periodic reporting on a Class III device small business fee |
$3,864 |
$3,280 |
| Annual establishment registration fee standard fee |
$6,493 |
$5,672 |
| Annual establishment registration fee small business fee |
$6,493 |
$5,672 |
To summarize:
Fiscal Year 2023 introduces varied changes in FDA User Fees, reflecting the dynamic landscape of the pharmaceutical, biologics, and medical device domains. Staying well-informed is paramount for industry professionals and organizations as they navigate these financial adjustments. As the FDA continues to prioritize healthcare product safety and efficacy, user fees remain essential in supporting these endeavors.
For precise insights into how these fee changes may affect your organization or submissions, consult the official FDA guidance and regulatory experts. ProPharma, leveraging its extensive regulatory expertise, stands ready to assist you in comprehending the updated fee structure and crafting strategies that seamlessly adapt to these changes. Our collective efforts ensure that the FDA can continue to fulfill its crucial mission of safeguarding public health while fostering innovation in the ever-evolving healthcare sector.
Take proactive steps today; contact ProPharma for personalized guidance and stay ahead of the curve.
