The European Medicines Agency has called for the suspension of sales in all of Europe of many commonly used generic drugs, including at least four widely used psychiatric medications, after uncovering corrupt practices in the regulatory approval processes for the drugs.
“A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended,” stated the EMA press release. “The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.”
An investigation of GVK Biosciences found that staff were falsifying electrocardiograms during clinical trials. “These manipulations appeared to have taken place over a period of at least five years,” stated the EMA press release. “Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site.”
If there was adequate scientific information about the drugs available from other sources, the EMA did not recommend suspension. However, if the drug’s approval was based almost entirely on studies done by GVK Biosciences, then the EMA has recommended banning sales of the drugs. The drugs being recommended for suspension include the antipsychotic quetiapine, widely used off-label as a sleep aid, and the common SSRI antidepressants escitalopram and venlafaxine. Clonazepam, a benzodiazepine often used to treat anxiety, was also recommended for suspension. The recommendations will go before the parliament of the European Union. The complete list of drugs is available on the EMA website.
In response to the EMA decision, Medscape reported that the US FDA promised to take “swift and appropriate action” if it “identifies issues concerning GVK Biosciences that relate to products approved by the FDA.”
GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies (EMA press release, January 23, 2015)
Suspend Dozens of Drugs Based on Flawed Studies, EMA Says (Medscape, January 23, 2015. Free registration.)