For Industry

Prescription Drug User Fee Amendments

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Latest News:
  • Completed PDUFA VI Deliverables

  • The FY 2019 Program Fee invoices were emailed Wednesday, August 15, 2018. Full payment of the invoice is due October 1, 2018. If you do not receive your invoice by August 17, 2018, please contact PDUFA User Fee staff at 301-796-7900 or at CDERCollections@fda.hhs.gov. (posted 08/15/2018)

  • The Prescription Drug User Fees for Fiscal Year 2019 have been published. Please see the table below for the 2019 and 2018 rates.

FY 2019 user fee rates:

User Fee Type

2019

2018

Application Fee - Clinical Data Required $             2,588,478 $             2,421,495
Application Fee - No Clinical Data Required $             1,294,239 $             1,210,748
Program Fee $                 309,915 $                 304,162

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V) and 2017 (PDUFA VI). On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications.

What is a human drug application?
PDUFA levies a user fee on certain human drug applications. Under PDUFA, the term human drug application means an application for

  • approval of a new drug submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or
  • licensure of certain biological products under section 351(a) of the Public Health Service Act (PHS Act).
What are application fees?
Each person that submits a human drug application is assessed an application fee as follows:
  •  A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.
  •  A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one- half of a full fee.

Human drug application fees are due when the application is submitted.

Supplements with unpaid fees  submitted prior to PDUFA VI will not automatically be considered acceptable for filing once PDUFA VI takes effect in FY 2018.  Applicants may submit a new supplement in FY 2018 under PDUFA VI, which will not incur a supplement fee.

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your application fee.

Are there any exceptions to the fee requirements?

  • Previously Filed Applications: If an application
    • was submitted by a person that paid the fee for the application,
    • was accepted for filing, and
    • was not approved or was withdrawn (without a waiver),

The resubmission of the application for the same product (by the same person) does not require an application fee.

  • Designated Orphan Drug or Indication
    • An application for a prescription drug product that has been designated as a drug for a rare disease or condition, under section 526 of the Act, is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.
       

What are prescription drug program fees?
Prescription drug product program fees are assessed annually for eligible products. The program  fees are assessed for each prescription drug product that is identified in such a human drug application approved as of October 1st of such fiscal year. 

Applicants may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application.

What is the definition of a prescription drug product?
Prescription drug product means a specific strength or potency of a drug in final dosage form for which a human drug application has been approved and which may be dispensed only by prescription under section 503(b) of the FD&C Act, and is also on the list of products described in section 505(j)(7)(A), or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act.
 

Are there drugs that are not included in the term prescription drug product?
Yes. The term prescription drug product does not include the following drugs:

  • Whole blood or a blood component for transfusion
  • A bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the PHS Act  A biological product that is licensed for further manufacturing use only
  • A drug that is not distributed commercially AND is the subject of an application or supplement submitted by a State or Federal Government entity

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your product fee.  

Are there any exceptions to the fee requirements?
Yes, there are. An annual product fee is not assessed if the prescription drug product is:

  •  listed in the Orange book with a potency described in terms of per 100 mL, or,
  •  the same product as another product approved under 
    • was approved under an application files under sections 505(b) or 505(j) of the FD&C Act,
    • is not in the list of discontinued products compiled under section 505(j)(7) of the FD&C Act.  

When are user fees due?

  • Application and supplement fees are due when the application or supplement is submitted.
  • Establishment and product fees are payable on or before October 1 of each fiscal year.
  • FDA issues invoices for establishment and product fees for the coming fiscal year in August of each year using the fee schedule for the coming fiscal year.

What is the Federal government's fiscal year?
The Federal government's fiscal year begins on October 1 and ends on September 30.
For example, fiscal year 2016 begins October 1, 2015, and ends September 30, 2016. Fiscal year 2017 begins October 1, 2016 and ends September 30, 2017.  

What are the instructions for the payment of fees?
A payment may be submitted electronically via the User Fees Payment Portal or by check, bank draft, U.S. postal money order, or wire transfer made payable to the order of the U.S. Food and Drug Administration. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution. Mail the payment to:

Food and Drug Administration
P.O. Box 979107
St. Louis, MO 63197-9000

If checks are sent by a courier requesting a street address, the courier can deliver the checks to the address below. Please note: This address is for courier delivery only.

U.S. Bank
Attn: Government Lockbox 979107
1005 Convention Plaza
St. Louis, MO 63101  

Include the user fee I.D. number (for application and supplement submissions only), the BLA/NDA number, or the invoice number and the FDA P.O. Box number 979107 on the enclosed check or in the documentation that comes with the payment.  

It would be helpful to include either 1) the user fee cover sheet (Form FDA 3397) for application or supplement fee payments, or 2) the invoice cover sheet for annual product or establishment fees.  

UFID Numbers for application and supplement submissions are obtained by completing the online User Fee Cover Sheet.

Are there any waivers of user fees?
Under section 736(d) of the FD&C Act, a waiver may be granted for one or more fees where:

  • a waiver or reduction is necessary to protect the public health
  • assessment of the user fees would present a significant barrier to innovation due to limited resources or other circumstances, or
  • the applicant involved is a small business submitting its first human drug application for review

Is there a reduction of fees for human drug applications that are refused for filing or are withdrawn before or after filing?
Yes. The following reductions or refunds are available:

  • 75 percent of the application fee is refunded for any application that is refused for filing or is withdrawn before filing.
  • if an application is withdrawn after it is filed, FDA may refund the fee or a portion of the fee if no substantial work was performed on the application or supplement. FDA has the sole discretion to refund a fee or a portion of the fee. The FDA's determination concerning a refund is not reviewable.

To be granted a waiver, the human drug applicant must submit a written request for the waiver.  

What is the timeframe for requesting a waiver, reduction, or refund of fees?
To qualify for consideration, a written request for waiver, reduction or refund must be submitted not later than 180 days after such fee is due.

How do I request a small business waiver and refund? To see if an applicant qualifies for a small business wavier of the biosimilar biological product application fee, they can submit Form FDA 3971 (Small Business Waiver and Refund Request) to CDERCollections@fda.hhs.gov

Who should I contact with questions about how to submit a waiver, refund, or reduction request?
Please contact CDERCollections@fda.hhs.gov with any questions about submitting your request.

Where should I send my request?
If you wish to send us mail (e.g. waiver request, refund request), you can send it to:  

For US Mail:
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903  

What information should I include in my request?
For more information about submitting a request for a waiver, refund or reduction request, please read FDA’s guidance for industry User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

Questions for the Prescription Drug User Fee staff? Email us at CDERCollections@fda.hhs.gov or call us at 301-796-7900.

Refund or waiver request? Please mail them to:

For US Mail:
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903  

Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at userfees@fda.gov or call 301-796-7200

Questions about Pay.gov? Email them at pay.gov.clev@clev.frb.org or call 800-624-1373.

Questions about the Orange Book? Email them at DrugProducts@cder.fda.gov

 

Page Last Updated: 11/14/2018
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