FDA Defends Its Oversight of Generic Drug Quality

March 1, 2019

FDA Commissioner Scott Gottlieb and CDER director Janet Woodcock rallied against recent media claims that generics are of lesser quality than brand name drugs, outlining methods the agency takes to protect their quality and effectiveness.

A Jan. 29 Bloomberg article claimed the agency’s push to lower drug prices by getting more generic meds to market has led to a weaker grip on global quality control. Another story by the publication on Jan. 31 alleged that Mylan’s Lipitor (atorvastatin) generic — manufactured in India — was found more likely to have negative side effects than competitors, after reviewing thousands of reports to the FDA.

Gottlieb and Woodcock spoke out against the media’s questioning of generic drug quality, saying they believe that the data analysis-based reports are faulty.

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