FDA discredits study claiming foreign generics tainted

The study by Preston Mason, a researcher at the Harvard-affiliated Brigham & Women’s Hospital in Boston, USA, found that generic heart drugs made outside the US were more likely to contain impurities. But Dr Woodcock says the research was flawed and the conclusions faulty.

Dr Woodcock told Bloomberg that the researchers ‘didn’t use the proper method to extract the active ingredient’ – atorvastatin – from samples, resulting in contamination. Defending the research, Dr Mason said that the same method was used on all of the drugs. Methanol was used to extract atorvastatin, exposing the generics to the solvent for a few days at most. However, only the ones made by foreign manufacturers contained high levels of contaminants. While tests on Pfizer’s Lipitor, even when left in methanol for 10 weeks, found very low levels of impurities.

Very little testing of generics in the US has been carried out previously, mainly due to the very small budget (US$2 or 3 million each year) that was allocated to this task. However, due to extra funding from generics user fees FDA has now allocated US$20 million for testing generics and has already been assessing generics since September 2013 [1].

Dr Woodcock said an FDA study about to be released using a different testing approach failed to find contaminants in generic heart drugs made in Canada, India, Slovenia and the US.

Dr Woodcock also dismissed complaints by doctors that patients sometimes do better when switched off certain generics, saying they may be based more on psychological factors than physical ones. ‘Psychological effects about feeling better and not feeling better and [the] doctor’s attitude toward things’ may affect how a patient feels, said Dr Woodcock.

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Reference
1. GaBI Online – Generics and Biosimilars Initiative. FDA starts widespread testing of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 11]. Available from:www.gabionline.net/Generics/General/FDA-starts-widespread-testing-of-generics

Source: www.gabionline.net