GDUFA’s Effect on Drug Master Files

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress. The Act, to be implemented from Oct. 1, 2012, is designed to streamline the generic-drug review process and has been welcomed by the pharmaceutical industry. However, there have been a lot of unanswered questions regarding the general outcome of GDUFA and how it will impact the industry.

The GDUFA agreement includes application fees for original Abbreviated New Drug Applications (ANDAs), prior approval supplements (PAS), and Type II Drug Master Files (DMFs) for APIs. Based on the fee structure, Type II DMFs will account for 6% and the API manufacturing facilities will account for about 14% of the GDUFA fees, respectively. To fulfill the GDUFA requirements and to streamline the DMF review process, the FDA Office of Generic Drugs (OGD) has established a DMF Review Team, with a future possibility of a division, which will be dedicated to review of API information submitted in Type II DMFs. With all the changes in the Type II DMF review processes that are covered in the GDUFA legislation and given the fact that there is currently a lack of adequate information available to the industry, there have been many industry questions and speculations regarding the impact of GDUFA on the submission and review of Type II DMFs.