EMA suspending almost 50 drugs over flawed CRO clinical studies
- The European Medicines Agency (EMA) is suspending close to 50 generic drugs, including drugs for diabetes, depression, hypertension and other medical conditions, due to flawed clinical studies conducted at a CRO in Hyperabad, India.
- The recall includes drugs such as donepezil, candesartan, metformin, and esomeprazole, covering various dosages and various names for the same drugs in different countries.
- Some of the pharma companies affected include Abbott Labs, Actavis, Dr. Reddy's Labs, Mylan, Sandoz, and Takeda.
This entire recall situation is related to clinical studies conducted by one contract research organization (CRO) in Hyderabad, India—GVK BioSciences. When French regulatory representatives looked closely at studies conducted by GVK, they discovered that there had been a trend of data manipulation involving electrocardiogram (ECG) data.
Although ECG data is not essential in order to demonstrate bioequivalence, evidence of data manipulation goes back five years and could also suggest other types of activity that might pollute the data.
So far, the FDA has not taken action based on this information, though the EMA injunction extends to the entire E.U.