West Pharmaceutical Services Blog: What GDUFA II Means for West’s Generics Customers

Following the announcement of the Generic Drug User Fee Act (GDUFA I) in 2012, the US Food and Drug Administration’s (FDA) office of generic drugs (OGD) was trying to manage a growing backlog of regulatory applications.

The introduction of user fees to the generic drug approval process permitted the FDA to increase resources to address increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a five-year span, resulting in reductions in both the generic drug application, backlog, and application review times.

As with other FDA user fee acts, GDUFA I was designed to require renewal after five years. Renewal terms were agreed between the FDA and generic drug industry groups in 2016.

Agreed changes for GDUFA II included:

• Modified fee structures to provide relief to small businesses
• Performance goals to further reduce backlogs and review times
• Enhanced communication opportunities between generic drug applicants and the FDA
• A mechanism for meetings with the FDA on complex products

The new fee structure, which begins when GDUFA II becomes effective on 1 October, will provide regulatory and financial relief in several areas, especially for smaller generics companies.

One significant change is that fees will no longer be charged for prior approval supplements (PAS). This fee will be eliminated under GDUFA II, as the previous number of PAS filed each year was too unpredictable to allow the FDA to accurately forecast fee collections. In addition, the Agency recognised that companies are sometimes required to file a PAS at the FDA’s request, which imposed an unwarranted burden on industry.

Under GDUFA I, significant process and product changes, submitted for prior approval, incur a fee of more than $35,000 for each affected drug application. Elimination of the PAS fee under GDUFA II, will effectively remove a potential barrier to generics customers and help to simplify their decision making processes.

For example, a customer wishing to upgrade an existing container closure system to incorporate a more modern closure, such as a West AccelTRATM component, can do so without needing to incorporate PAS fees in their submission plans, if they file the change under GDUFA II.