US FDA jacks up FY 2014 generic drug user fees

In a Federal Register notice, the US Food and Drug Administration has announced the rate for the Abbreviated New Drug Application (ANDA, relevant to regulatory approval of generic medicines), Prior Approval Supplement to an approved ANDA (PAS), Drug Master File (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year 2014. These fees will be effective from October 1, 2013, and would be reviewed after a year.

• The new ANDA fee has been fixed at $63,860, which is around 24% higher than the existing $51,520. An ANDA contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.

• Similarly, the PAS fees for FY 2014 have been increased by 24% to $31,930. The PAS application includes changes to be made to approved products.