700 Drugs Face Suspension in EU Over GVK Biosciences Flap

The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data.

The EMA’s Committee for Medicinal Products for Human Use reviewed 1,000 pharmaceutical formulations and strengths of drugs that underwent bioequivalence testing at the GVK site.

Investigators found the company submitted the ECG results from a single individual for multiple subjects in data used to support approval of generic applications. CHMP concluded that the faulty data was a site-wide problem and it cast doubt on all the data at the site.

Some 300 of the drugs reviewed by the committee were supported by data from sources other than GVK, CHMP said, and should remain on the market. That leaves about 700 drugs that it recommends be withdrawn from the market unless they fulfill a critical medical need for which no alternative is available. The European Commission must make a final decision before the products will be withdrawn.

Among the affected drugs are versions of Forest Laboratories’ Lexapro (escitalopram), AstraZeneca’s Nexium (esomeprazole), Novartis’ Diovan (valsartan) and Pfizer’s Effexor (venlafaxine) by generics giants such as Mylan and Dr. Reddy’s Laboratories.

The EMA initially left it up to individual member states to decide whether to keep the drugs on the market. Germany, France and Belgium suspended their approvals in the last two months. The FDA has said it will take action on the drugs in the U.S. if it receives evidence of falsified data from GVK involving products it has approved.

GVK did not return a request for comment by press time.

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