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Quality in Generic Pharmaceuticals: Part 2

It has been almost a year since Clarkston first released its study on Quality in Generic Pharmaceuticals. Within that year, the industry has seen several pivotal events. The Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. There was much discussion of quality and bioequivalence, given some high profile cases that made headlines. Generic pharmaceuticals filled 80 percent of the prescriptions dispensed in the U.S., but consumed just 27 percent of total drug spend.1 And industry and regulators have continued to work toward finalizing the pathway for U.S. biosimilars – a critical event that will increase patient access to an entirely new type of cost effective life enhancing medication.

It is with this backdrop that we now release the second installment of the Quality in Generic Pharmaceuticals report. What has changed is an increased focus on inspections of foreign facilities. These still make up a small fraction of the overall drug facility inspections, but have increased some 70 percent from the data used to create this analysis just one year ago. What remains the same is the very small volume to incident ratio that demonstrates the clear safety and efficacy of generic drugs. And finally, what has dynamics of both permanence and change, are the best and emerging practices that generic pharmaceutical companies are using to ensure they maintain their high standards of quality as their distribution base covers an ever larger and more global patient population.

The data used for this analysis comes from the FDA’s inspection database.2 Our previous report used the data set covering inspection activity for the two years from October 2008 through September 2010. In refreshing this report, the FDA has added inspection results for the two year period ending September 2012. Comparisons between these time periods and conclusions drawn from the analysis are detailed below.

Breakdown of Inspections by Center
FDA inspection activity across all centers increased between the periods of comparison, with food showing the greatest increase and veterinary medicine showing the least. Like any other large organization, the FDA works to align financial and personnel resources to the areas of need that they have in order to fulfill their mission. At a macro level, there were clear increases in the amount of inspection activity in the areas of food, drugs, and medical devices. And whereas inspections of foreign drug/biologic manufacturing facilities have increased, it will be critical for the FDA to continue to focus resources and energy on the global supply chain, including API manufacturers, contract manufacturers, and packagers. Hopefully the increased funding from GDUFA, plus better analytics and operational efficiencies at the FDA, will help in this regard.

For more, please download our report.