German authorities update list of drugs with falsified study data

Germany's Federal Institute for Drugs and Medical Devices (BfArM) is continuously updating a list of medicines whose market authorizations are being suspended. The suspensions are linked to bioavailability studies conducted by the Indian firm GVK Biosciences, where data is suspected to be falsified.

The Federal Association of German Pharmacists' Associations (ABDA) issued a statement on December 11, 2014, noting that the BfArM had published its initial list of affected drugs the previous day. This list has seen several updates since its release. Some pharmaceutical companies have lodged objections to the BfArM's decisions, and the agency is currently reviewing these appeals, which will lead to further list adjustments.

The European Medicines Agency (EMA) is conducting further investigations into the falsified data from GVK Biosciences' bioavailability studies. As part of this European risk assessment procedure, it remains possible that additional drug approvals could be suspended.

ABDA stated it would provide further information regarding practical procedures for pharmacies as soon as details become available. The BfArM emphasized that the most current version of the affected medicines list is exclusively available on its official website.