Drug Companies: FDA User Fees FY 2025 Rates & Updates

August 7, 2024 By admin Comments are Off

Drug companies: Check the FDA’s FY 2025 user fee rates for drugs, biosimilars, medical devices, and OTC monographs. See new fees and changes.

The US Food and Drug Administration (FDA) has released its user fee rates for fiscal year 2025, covering its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph drug programs. These rates are set by evaluating the agency’s resources against the expected number of applications, based on historical trends.

Prescription Drug User Fee Amendment (PDUFA VII)

For FY 2025, the FDA projects a base revenue of $1,358,764,346 under the Prescription Drug User Fee Amendment (PDUFA VII), which represents an 8% increase from FY 2024’s estimated revenue of $1,256,844,387. The fee rates for PDUFA are as follows:

Applications Requiring Clinical Data: $4,310,002 (6% increase from FY 2024)
Applications Not Requiring Clinical Data: $2,155,001 (6% increase from FY 2024)
Program Fees: $403,889 (3% decrease from FY 2024)

Generic Drug User Fee Amendment (GDUFA III)

The FDA estimates a base revenue of $613,538,015 for the Generic Drug User Fee Amendment (GDUFA III) in FY 2025, marking a 5% increase from the FY 2024 estimate of $582,500,000. The fee rates for GDUFA are:

ANDA: $321,920 (28% increase from FY 2024)
Drug Master File: $95,084 (0% change)
Domestic API Facility: $41,580 (3% increase)
Foreign API Facility: $56,580 (2% increase)
Domestic FDF Facility: $231,952 (5% increase)
Foreign FDF Facility: $246,952 (5% increase)
Domestic CMO Facility: $55,668 (5% increase)
Foreign CMO Facility: $70,668 (4% increase)
Generic Drug Applicant – Large Firm: $1,891,664 (9% increase)
Generic Drug Applicant – Medium Firm: $756,666 (9% increase)
Generic Drug Applicant – Small Firm: $189,166 (9% increase)

Biosimilar User Fee Amendments (BsUFA III)

For the Biosimilar User Fee Amendments (BsUFA III), the FDA estimates a base revenue of $51,058,823 for FY 2025, reflecting a 4.8% increase from the FY 2024 estimate of $48,700,243. The fee rates for BsUFA are:

Initial BPD: $10,000 (0% change)
Annual BPD: $10,000 (0% change)
Reactivation: $20,000 (0% change)
Applications Requiring Clinical Data: $1,471,118 (44% increase)
Applications Not Requiring Clinical Data: $735,559 (44% increase)
Program Fee: $256,168 (44% increase)

The FDA anticipates about 23 new biological product development (BPD) programs and 88 additional BPD programs that will pay the annual fee, totaling 111 applications.

Medical Device User Fee Amendment (MDUFA V)

For FY 2025, the FDA estimates a base revenue of $350,746,400 under the Medical Device User Fee Amendment (MDUFA V), which is a 4% increase from FY 2024’s estimate of $335,750,000. The fee rates for MDUFA are:

Full Fee Applications: $540,783 (12% increase)
Small Business Full Fee: $135,196 (12% increase)
Panel-Track Supplement: $432,626 (12% increase)
Small Business Panel-Track Supplement: $108,157 (12% increase)
De Novo: $162,235 (12% increase)
Small Business De Novo: $40,559 (12% increase)
180-Day Supplement: $81,117 (12% increase)
Small Business 180-Day Supplement: $20,279 (12% increase)
Real-Time Supplement: $37,855 (12% increase)
Small Business Real-Time Supplement: $9,464 (12% increase)
510(k): $24,335 (12% increase)
Small Business 510(k): $6,084 (12% increase)
30-Day Notice: $8,653 (12% increase)
Small Business 30-Day Notice: $4,326 (12% increase)
513(g): $7,301 (12% increase)
Small Business 513(g): $3,650 (12% increase)
Annual Periodic Reporting: $18,927 (12% increase)
Small Business Annual Periodic Reporting: $4,732 (12% increase)

Over-the-Counter Monograph Drug User Fee Amendment (OMUFA)

The FDA also published the user fee rates for the Over-the-Counter (OTC) Monograph Drug User Fee Amendment (OMUFA) for FY 2025. The agency has not yet released the rates for monograph drug facilities (MDF) and contract manufacturing organizations (CMO) or base revenue expectations, which will be provided later. The OMUFA fee rates are:

Tier 1 OMOR Fee: $559,777 (4% increase)
Tier 2 OMOR Fee: $111,955 (4% increase)

the FDA’s updated user fee rates for FY 2025 reflect its ongoing commitment to supporting the development and review of drugs, biologics, and medical devices. The increases across various programs underscore the agency’s efforts to manage growing application volumes and maintain high standards of regulatory oversight. These adjustments aim to ensure that the FDA can continue to facilitate innovation while addressing the evolving needs of the pharmaceutical and medical device industries.