Key Points on Generic Drug User Fee of U.S. FDA

On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by U.S. President Obama. GDUFA requires pharmaceutical industry to pay user fees to supplement the costs of ANDA review and GMP inspection. GDUFA also requires generic drug and associated API establishments around the world to self-identify with the FDA. The following key points put together by Blue Bell Consulting are intended to help the industry in familiarizing these new regulations and requirements.

1. Facilities that manufacture generic drugs, Type II APIs, or both are required to self-identify with the FDA. The fiscal year 2013 reporting period ends on December 3, 2012 with grace period of two weeks to December 17, 2012.
2. For an ANDA that was originally submitted before October 1, 2012, that is still pending on that date, and that has not been tentatively approved on that date, the ANDA fee is $17,434. It is due no later than November 23, 2012.
3. For an ANDA submitted on and after October 1, 2012, the ANDA fee is $51,520 and the PAS fee $25,760. These rates are effective on October 1, 2012, and will remain in effect through September 30, 2013.
4. For a Type II DMF, no matter when it was submitted, that is referenced for the first time by an ANDA on or after October 1, 2012, the one-time fee is $21,340. The rate is effective on October 1, 2012, and will remain in effect through September 30, 2013. The DMF holder may elect to pay the fee before a letter of authorization for reference is requested in order to gain market advantage.
5. The paid DMF will then undergo an initial completeness assessment by the FDA. If the DMF passes the completeness assessment, it will be placed on a publicly available list of DMFs available for reference. The FDA will conduct a full review of the referenced DMF before it reviews the associated ANDA.
6. A facility that is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more generic drugs and/or APIs is required to pay facility fees. The rate for fiscal year 2013 will be published on January 13, 2013. The amount of the fee for a facility located outside the U.S. will be higher than that for a U.S. facility. The differential amount is designed to reflect the higher costs of GMP inspections.
7. No fee waiver or reduction provision for small business entities was included in GDUFA.
8. GDUFA fees apply only to generic drugs that enter interstate commerce and that are manufactured for human use in the United States.