The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User Fee Amendments (GDUFA). The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. This reauthorization of GDUFA (GDUFA II) went into effect on October 1, 2017 and will remain in effect through September 30, 2022. This article discusses in detail the need for Generic Drug User Fee Amendments (GDUFA), fee structure and related information
What is the generic drug user fee amendment/Act (GDUFA)?
Generic Drug User Fee Amendment or Generic Drug User Fee Act (GDUFA) is a law enacted by the United States of America (USA) under the Food and Drug Administration Safety and Innovation Act (FDASIA) to speed the access of safe and effective generic drugs to the public and reduce the overall cost to the industry.
Need for generic drug user fee Amendment (GDUFA)
The Hatch-Waxman Act of USA was a huge success however after a certain period of time of its implementation the FDA’s resources could not keep pace with the increasing number of ANDAs. This resulted in delayed approval of generic drugs. To eliminate this backlog and provide resources for more inspections, FDA proposed generic drug user fees. In 1992, the FDA gained the authority to collect user fees from the manufacturers of brand-name prescription drugs and biological products. This was based on two main concepts- Performance goals related to target completion times for various review processes and use of fees related to the activities to support the review of new product applications.
Generic drug user fee amendment (GDUFA I)
The Generic User Fee Amendments (GDUFA I) authorized the FDA to collect fees from drug manufacturing industries for FDA activities associated with generic drugs. Under GDUFA I, such fees are allowed to be collected from October 2012 through September 2017. It established the type of fees to be paid by the manufacturer. It includes the application fee for an Abbreviated New Drug Application (ANDA) and application fee for a prior approval supplement to an ANDA are paid at the time of filing or application submission. The Drug Master file fee, the facility fee for the facility making the API and the facility fee for the facility producing the Finished Dosage Form (FDF). Facility fees are annual fees for each establishment.
Re-authorisation of Generic drug user fee amendment (GDUFA II)
The five-year generic drug user fee authority ended on September 30, 2017. Under the GDUFA II performance goal agreement between FDA and industry, the agency, as proposed, would review and act on 90% of standard original ANDAs within 10 months from the date of submission. FDA also said it will review and act on 90% of standard and priority minor ANDA amendments within 3 months of the amendment submission date and 90% of standard major PAS amendments within 6 months of the amendment submission date if pre approval inspection is not required. For priority major PAS amendments, FDA said it will review and act on 90% within 4 months of the amendment submission date if pre approval inspection is not required. Here are a few fee guidelines as per the latest reauthorization.
- The firms that are sponsoring one or more approved ANDAs are subjected to an annual fee.
- The Prior Approval Supplement (PAS) fee is eliminated.
- The sponsors do not have to pay per ANDA fee.
- The sponsor can pay only the Finished Dosage Form (FDF) fee if it falls under both the API and FDF facilities.
- The facilities have to pay a foreign fee differential if it falls outside the FDA jurisdiction.
Generic drug user fee amendment II User Fee Rates
|User Fee Type||FY 2020||FY 2021|
|ANDA||$ 176,237||$ 196,868|
|DMF||$ 57,795||$ 69,921|
|Program||Large Size||$ 1,661,684||$ 1,542,993|
|Medium Size||$ 664,674||$ 617,197|
|Small Size||$ 166,168||$ 154,299|
|Facility||Domestic API||$ 44,400||$ 41,671|
|Foreign API||$ 59,400||$ 56,671|
|Domestic FDF||$ 195,662||$ 184,022|
|Foreign FDF||$ 210,662||$ 199,022|
|Domestic CMO||$ 65,221||$ 61,341|
|Foreign CMO||$ 80,221||$ 76,341|
|Backlog||$ 17,434||$ 17,434|
The Generic Drug User Fee Amendments (GDUFA) enables the access of safe and effective generic drugs to the public and reduces the overall cost to the industry. The latest reauthorization of this act GDUFA II sheds even more light on the access, transparency, safety and effectiveness that ensures that generic drug manufacturers fulfil the quality standards and provide the general public with high- quality generic drugs at a lower cost.
- https://www.fd a.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments