Steve LoCastro

Director, Regulatory Affairs

March 02, 2017

GDUFA II is Coming: What it Means for West's Generics Customers

When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA’s 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 FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times.

 

As with other FDA user fee acts, GDUFA was designed to require renewal after five years. Renewal terms were agreed upon between FDA and Generic drug industry groups in 2016, and changes agreed upon for GDUFA II include:

  • 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 FDA on complex products

 

The new fee structure that begins when GDUFA II becomes effective on October 1, 2017 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, because previously the number of PAS’ filed each year was too unpredictable to allow FDA to accurately forecast fee collections. In addition, the Agency recognized that companies are sometimes required to file a PAS at the FDA’s request, which imposed an unwarranted burden on industry.

 

What Does this Mean for West’s Generics Customers?

Under GDUFA I, significant process and product changes, submitted for prior approval, incur a fee of over $35,000 for each affected drug application. The elimination of the PAS fee under GDUFA II, will effectively remove a potential barrier to Generics customers and will therefore 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, like 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.

 

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West Pharmaceutical Services, Inc. has been a trusted partner for generic pharmaceutical companies for many years. With GDUFA II becoming effective on October 1, 2017, now is the time to contact West about transitioning to container closure solutions that can enhance the quality of your drug product. For more information on how West can provide regulatory support, from your initial evaluation through to regulatory approval, contact us today.

 

 

 

 

 

AccelTRATM is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.