Germany suspends drugs trialled by GVK Bio due to ongoing data falsification concerns
European regulators have been reviewing approvals that included GVK since September after ANSM, the French Agency for the Safety of Health Products, raised concerns (here in French) about studies conducted at a site in Hyderabad between July 2008 and 2013.
At the time, ANSM said it found “falsifications of electrocardiograms” in the nine studies it examined, explaining that the ECG data appeared to have been derived from a single individual, rather than multiple volunteers.
The Paris-regulator alleged that at least 10 GVK employees were involved in manipulating the data, which it said was indicative of systemic problems.
German suspension
Last Friday Germany’s BfArM (Federal Institute for Drugs and Medical Devices) said it had suspended marketing authorizations for some products for which GVK had run studies.
None of the drugs removed from pharmacy shelves in Germany were named, although there was speculation about products involved in reports over the weekend.
BfArM also said it was reviewing 176 authorizations for a total of 28 pharmaceutical companies.
In response the European Medicines Agency (EMA) reiterated that it “is currently reviewing findings of non-compliance with good clinical practice at this site and determining their impact on medicines authorised on the basis of studies performed at the site.”
The review aims to identify the drugs involved and assess all data according to the agency, which said it will recommend whether marketing authorisations for the products should be maintained, varied, suspended or withdrawn in January 2015.
No response
GVK did not respond to a request for comment about the new German ban, but did state on its website that it has addressed all the issues raised by ANSM and submitted independent assessments that prove the cardiology data was from multiple individuals.
The Indian contractor also expressed its disappointment that European authorities have not been reassured by its efforts and predicted that Marketing Authorisation Holders (MaH) affected “will need to repeat the studies in the next 12-15 months.”
