U.S. Food & Drug Administration (FDA) Dear Colleague Letter
Date: May 14, 2018
Subject: Prescription Drug User Fee Amendments of 2017 (PDUFA VI) Policy Changes
This letter informs recipients of changes in FDA's policies concerning prescription drug products under PDUFA VI. It requests verification of company contact information and PDUFA program fee-eligible products for the Fiscal Year (FY) 2019 program fee invoice, which is scheduled for issuance in August 2018. Companies are asked to confirm or correct their data by Friday, June 15, 2018.
I. Policy Changes Under PDUFA VI
The following policy changes affect program fee assessments:
1. "Same Product as Another Product" Program Fee Exception
Section 736(a)(2)(B)(ii) of the FD&C Act states that a prescription drug product will not be assessed a program fee if it is the same product as another product approved under an application filed under section 505(b) or 505(j) of the FD&C Act and is not listed as discontinued. To be considered the "same product as another product," FDA must determine that the product is therapeutically equivalent to another drug product. Therapeutically equivalent products are identified by "A" codes in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
2. Liquid Parenteral Biological Products Approved under Section 351 of the PHS Act
- Assessing Strength or Potency: For liquid parenteral biological products, FDA will consider both the total amount of drug substance and its concentration when assessing program fees. Products with different strengths or potencies will receive separate entries and fees.
- Auto-Injectors, Prefilled Syringes, and Vials: An auto-injector with the same strength or potency as a prefilled syringe or vial will generally be given a separate entry and assessed a separate program fee.
These changes aim to align the assessment of program fees for products approved under section 351 of the PHS Act with those under section 505 of the FD&C Act.
II. Review Your Company's Contact Information
Attachment A – Company Contact Information: Companies must review and correct the contact information FDA has on file for receiving correspondence and inquiries regarding prescription drug user fees. The updated information should be emailed to CDERCollections@fda.hhs.gov.
III. Confirm Your NDA Prescription Drug Products in the Orange Book
Companies should review their existing product lists and identify any products that should not be assessed a program fee, providing reasons (e.g., generic competition, discontinuation). Any omitted products should be added with appropriate details. Changes should be made directly on the provided lists in Attachment B.
It is recommended to review the company's current list of drug products in the Orange Book and notify the Orange Book staff (OrangeBook@fda.hhs.gov) of any changes, such as products no longer marketed, by June 30, 2018. A courtesy copy of this information should be sent to the User Fee staff.
Failure to update the Orange Book list by June 30, 2018, may result in inclusion on the FY 2019 invoice. Refunds may be available if the product is moved to the Discontinued Drug Product List by September 30, 2018, with a written refund request submitted within 180 days of the fee due date.
IV. Confirm Your Biological Products on the CDER and CBER Lists
Companies should review the CDER Billable Biologic List and CBER's User Fee Billable Biologic Products and Potencies list to ensure their biological products are accurately represented. Links to these lists are provided:
- CDER Billable Biologic List: https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm164641.pdf
- CBER Billable Biologic List: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/UCM606472.pdf
If a company is no longer marketing a biological product that is still listed, they should notify the relevant staff:
- For CDER regulated products: Contact CDER User Fee staff in writing to move the product to the CDER Discontinued Product List.
- For CBER regulated products: Submit a Product Correspondence to the Product Review Office to move the product to the CBER Discontinued Products List, copying the CBER User Fee staff.
Notifications for changes should be made by June 30, 2018:
- CDER biological products: Email CDER User Fee staff at CDERCollections@fda.hhs.gov.
- CBER biological products: Email CBER User Fee staff at CBERPDUFAstaff@fda.hhs.gov, including CDERCollections@fda.hhs.gov on the correspondence.
Similar to drug products, failure to notify by June 30, 2018, may result in inclusion on the next fiscal year's invoice, with potential refunds available if notification to move the product to the Discontinued Product List is received by September 30, 2018.
V. How to Provide the Requested Information
Attachments A and B, including the updated product list, should be emailed to the PDUFA User Fee staff at CDERCollections@fda.hhs.gov by June 15, 2018.
For any questions, please email CDERCollections@fda.hhs.gov.
The FDA looks forward to receiving the company's response by June 15, 2018.
