Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain bioequivalence studies to be repeated based on improper data collection and analysis processes. Bioequivalence studies, often conducted to bring generic drugs to market, establish that the generic drug has the same 'effect' as the original drug. Obviously, these are critical trials, as they also establish the safety profile of the generic compound.

The consequence of notification has been quite substantial. It has been recommended that a number of generic drugs be removed from the market until accurate data is collected by repeating these trials, incurring significant, additional expense and impacting sales.

According to an article in PulseToday.com, "European Medicines Agency (EMA) advisors said bioequivalence studies carried out on the drugs at Semler Research Centre in Bangalore were 'flawed' and 'cannot be relied on...The EMA advisors concluded 'the studies conducted at Semler cannot be accepted in marketing authorization applications in the European Union' and, therefore, 'no medicines can be approved on the basis of these studies'."