Up to $190.389 for FDA's New Inspections Fees

Many in the GMP environment haven't realised the consequences of the so-called Generic Drug User Fee Act (GDUFA) yet. We've already reported several times about the new Act and its consequences (e.g. in our GMP News about the GDUFA from 19. January 2012).

The FDA has now published the exact fee rates for facility inspections. The following fees (per site) will be due by 4 March 2013:

  • Domestic FDF facility:  $175,389
  • Foreign FDF facility (i.e. manufacture in Europe or Asia): $190,389
  • Domestic API facility:  $26,458
  • Foreign API facility (i.e. manufacture in Europe or Asia):  $41,458

The FDA strongly advises all the companies to pay the fees within the period prescribed. Facilities who don't pay their fee cannot deliver their products to the USA any longer. Moreover, the FDA may prosecute the companies concerned in the USA. Because of their complexity, costs for foreign inspections are $15,000 higher than domestic ones.

The aim of the FDA is to perform more inspections. Indeed, they've observed that in the past GMP inspections had rarely been performed promptly and in regular intervals of 2 years. Whereas US facilities have been inspected pretty regularly, foreign facilities have been inspected by the FDA on average every 9 years. The fees collected by the GDUFA should ensure enough resources for inspections.

The FDA has published a Question and Answer document to provide information about the facility fees. The document points out for example that a facility which manufactures both generic finished drug products (FDFs) and APIs incurs both annual FDF and annual API facility fees.

The number of FDA inspections particularly in Europe and Asia should increase tremendously. It is likely that many facilities won't comply with the FDA requirements anymore. Eventually, the number of Warning Letters and Import Alerts is likely to increase.

Source:  Federal Register Notice of Generic Drug User Fee-Facility Fee Rates for Fiscal Year 2013

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