PDUFA VI: FDA Explains User Fee Changes in Draft Guidance

Posted 12 October 2017 By Zachary Brennan


The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Changes to the fee structure under PDUFA VI mean FDA can collect two types of fees through 2022: human drug application fees (accounting for 20% of the total), collected at the time applications are submitted, and prescription drug program fees (accounting for 80% of the total), which are collected annually for certain prescription drugs.

Exceptions to the application fee include previously filed applications and applications for drugs designated as orphan drugs for a rare disease.

"If an application is refused for filing or withdrawn without a waiver before filing, FDA will refund 75 percent of the application fee," the draft says. "If an application is withdrawn after it is filed, FDA may refund the fee or a portion of the fee if no substantial work was performed on the application after the application was filed. FDA has the sole discretion to refund a fee or a portion of the fee. The FDA's determination concerning a refund on this basis (no substantial work was performed on the application) is not reviewable."

In terms of program fees, each sponsor is required to pay the annual fee for each prescription drug approved as of 1 October of each fiscal year, but applicants may not be assessed more than five prescription drug program fees for a fiscal year.

The draft also outlines when a prescription drug product is not assessed a program fee, including if "the product is on the list compiled under section 505(j)(7) with a potency described in terms of per 100 milliliters (large volume parenteral)."

The agency notes that if an application is submitted without an application fee or if a person is in arrears for nonpayment of any program fees, the application will be incomplete and FDA will not accept it for filing.

PDUFA VI also eliminated fees for drug application supplements, establishment fees and the so-called "fees-exceed-costs waiver."

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017: Draft Guidance for Industry

Share this article:

Categories: Drugs, Government affairs, Submission and registration, News, US, FDA

Tags: PDUFA VI, prescription drug user fees, draft guidance

Regulatory Exchange: Latest Updates From the Community