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Quality in Generic Pharmaceuticals: Part 3

Over the last two years, Clarkston Consulting has released its study on Quality in Generic Pharmaceuticals. As in the past, the generic pharmaceutical industry has continued to dominate the market, with 80 percent of drugs prescribed in the U.S. being generic. This should come as no surprise since generic drugs are 80 to 85 percent less expensive than their brand counterparts and have saved U.S. consumers, patients, and the healthcare system $1.2 trillion in the past decade.

In this third installment of the Quality in Generic Pharmaceuticals research brief, we will discuss the continued low volume to incident ratio of generic pharmaceuticals, demonstrating their upper hand in safety and efficacy. This year we will also focus on the increase of inspections in foreign facilities, and how these and other findings are impacted by practices that the industry is using, or looking to adopt to maintain its high standards of quality.

The data used for this analysis comes from the FDA’s inspection database.2 Our previous report compared data from 2009 to 2012. With the FDA’s addition of the 2013 inspection activity, this report will compare a two year range of inspections from October 2011 to September 2012, and October 2012 to September 2013. The comparisons and results from the analyses are detailed below.


Comparing the previous year’s analysis to the October 2012 to September 2013 time range, there was a 28 percent decrease in the total number of FDA inspections by center and a 23 percent decrease in the number of drug and biologics inspections by focus area. The decrease in number of inspections can perhaps be attributed to the reorganization of the FDA, which has impacted not only the Office of Generic Drugs, but the FDA as a whole.

The charts below represent weighted averages of the number of inspections each year. Inspections in the food and drug evaluation centers decreased slightly, by seven and one percent respectively. Despite this decrease, both food and drug centers have seen the largest overall percent increase in the past four years. The number of inspections among other centers has increased in percentage.

Breaking down the inspections by focus area, there was an eight percent decrease in Drug Quality Assurance and a one percent decrease in Drug Branding/Labeling. These two areas saw the largest growth in number of inspections in the last four years. Also, although inspections in Drug Quality Assurance increased in the past, the number of incidences where the inspections required official action actually decreased, which may explain why the FDA wishes to concentrate other areas.

The FDA has often struggled to fully manage foreign facility inspections due to a lack of appropriate resources and funding. GDUFA was passed, in part, to address this issue and most likely contributed to the 20 percent increase in foreign facility inspections in 2013 compared to the previous October 2011 to September 2012 timeframe.

For more, please download our report.