FDA starts widespread testing of generics

Generics and biosimilars Initiative

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FDA starts widespread testing of generics

Genéricos/General | Posted 28/02/2014 0 Post your comment

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.

The new initiative involves at least a dozen academic centres, in a testing programme that will run through 2017. Research for 2014 will focus on heart drugs, attention deficit hyperactivity disorder (ADHD) treatments, immunosuppressants, anti-seizure medicines and antidepressants.

In the past, testing of generics was done only occasionally in the US, due mainly to a very small budget – US$2 or US$3 million each year – being allocated for such research, according to Ms Kathleen Uhl, Acting Director of the FDA’s Office of Generic Drugs. The collection of generic user fees from industry has ‘enabled the agency to put more broad-based testing into action,’ Ms Uhl told Bloomberg.

Among the academic centres to receive grants are Duke University, Johns Hopkins University, Brigham and Women’s Hospital in Boston and the universities of Florida, Michigan and Maryland. Researchers are studying how absorption, inactive ingredients and packaging affect generic drug efficacy.

The agency is also reviewing a 2013 study by a Boston-based researcher that found widespread impurities in generics of Pfizer’s blockbuster high cholesterol treatment Lipitor (atorvastatin) made outside of the US.

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Source: Bloomberg, The Washington Post