Today, the FDA sent out a PDUFA Dear Colleague letter (here) asking firms to verify program fee assessment information that the Agency has relative to applications covered under PDUFA VII. The letter states that “[u]nder PDUFA VII, a program fee is assessed annually for certain prescription drug products identified in a human drug application approved as of October 1 of such fiscal year (FY), with a maximum of five prescription drug program fees for a fiscal year for such prescription drug products identified in a single approved human drug application.”
Invoices will be issued by the FDA in August 2026. The FDA wants firms to assess the current listings to ensure that the invoices are accurate based on the information that the Agency currently has in its records. The FDA asks for your firm’s help by reviewing and either confirming or correcting your company’s contact information and the program fee eligible products.
Attachment A to the letter contains the information that the “FDA has on file for the person designated by your company to receive correspondence, invoices, and inquiries concerning prescription drug user fees,” while Attachment B “contains a list of your products that FDA anticipates being eligible for the FY 2027 program fees.”
The letter provides specific details for making changes and/or corrections to the listings and recommends “reviewing your company’s current list of drug products in the Orange Book and notifying the Agency of your product’s marketing status (e.g., the product is being delayed from marketing after approval, the product is being discontinued, or the product is being withdrawn from sale).”
The letter also provides dates for which certain information must be submitted and also describes various scenarios for drugs approved and not yet marketed but for which marketing is expected during FY 2027 and notes that “if the product is marketed at any time during the same fiscal year, the product may be assessed program fees. For FY 2027 invoices, such submission should be submitted through the ESG gateway no later than June 30, 2026.” It also reminds firms to confirm their biological products on the CDER and CBER lists.
Be certain to review the invoice carefully once received because if you have a product that is not being marketed, failure to take appropriate action prior to certain deadlines could cost you a rather large six-figure fee for each product that mistakenly appears on the invoice.
