GDUFA Update

By Gil Y. Roth, Contract Pharma | January 22, 2013

A preview of our upcoming GDUFA & CMOs article

Last year in this space, we explored the proposed Generic Drug User Fee Amendments (GDUFA) and their potential impact on CMO/CDMOs (bit.ly/Vm6SFS). One of the key aspects of the GDUFA is the role of inspection fees to ensure safety of generic APIs and final dosage forms (FDF), and we spoke with several manufacturers to find out how they planned to deal with the proposed fees.

At the time, the GDUFA was still being negotiated in Congress and the inspection fees had not been determined, although they were supposed to account for $210 million of the FDA’s $299 million GDUFA budget, with DMF applications accounting for the remainder. Since then, GDUFA was signed into law and FDA has been working to implement the new rules.

The agency posted a spreadsheet with every self-identified facility from October 1, 2012 to January 7, 2013 online (1.usa.gov/ V4TRPT), yielding a list of 3332 entries. Some of those are multiple sites for the same company, and some are multiple entries for the same location, because GDUFA demands a facility be inspected for each category it falls under.

Now that the number of facilities subject to inspection has been finalized, the FDA was able to provide the 2013 fee schedule for each facility:
  • Domestic FDF facility:  $175,389
  • Foreign FDF facility: $190,389
  • Domestic API facility:  $26,458
  • Foreign API facility:  $41,458
The FDA noted, “Fees for FYs 2014-2017 will be adjusted for inflation and other factors, including the number of facilities that have self-identified each year.”

Next issue, we’ll revisit the topic to find out how CMO/CDMOs are going to deal with the costs of GDUFA and how they may impact relationships with generic clients. For a teaser, here are comments from Junan Guo, Ph.D., vice president, Pharmaceutical and Quality Services, at AMRI:

“While GDUFA provides great benefits to the overall generic industry, the effect is different on each company, depending on the mix of the business. AMRI has self-identified both its Rensselaer, NY and Albany, NY sites in the Capital Region of New York. One site is for manufacturing and testing and the other site is for testing only.

“The facility fees associated with the GDUFA self-identification process provide business advantages to the operations like our Rensselaer site, which provides contract cGMP manufacturing of bulk active pharmaceuticals and advanced intermediates for clinical phase scale-up requirements up to and including full scale commercial manufacturing. The facility fee is relatively small in comparison to the overall site business. In addition, GDUFA provides more timely approval for ANDAs, and reduces the competition from the smaller operations, especially small, international operations.

“Not surprisingly, the GDUFA self-identified facilities are less than what FDA expected. If generic manufacturing is not the major part of the business, the company or the site may choose to exit or not start the generic business if the facility fee becomes large relative to the overall business. For example, AMRI will consider the required facility fee before introducing the generic API or drug product into other AMRI sites globally.”


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