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Europe Bans 700 Generic Medicines Because of Flawed Clinical Tests But FDA Allows Them to Remain on Market in U.S.

Sep 1, 2015

The U.S. Food and Drug Administration (FDA) has found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but says it supports Europe's ban of about 700 products.

Last week, European regulators instituted a ban on 700 generic medicines that were approved based in part on what they said were flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India. The list of medicines includes different formulations and strengths.

The FDA is not taking any action on products sold here that included data from GVK studies in their applications, apparently because the FDA's own inspection of the plant did not raise the same concerns, according to the web site

The FDA has identified about 40 pharmaceutical product applications that contain GVK clinical study data between 2007 and 2012. The FDA does not believe there is any danger to patients from these products, based on its own inspection of GVK's facilities.

"We have identified the US applications that include data conducted at GVK BioSciences, Hyderabad, and FDA's subsequent inspection . . . did not reveal systemic issues that affect the safety or efficacy of drug products subject to pending applications or products approved in the US," an FDA spokesman wrote in an email. "If the FDA identifies issues concerning GVK BioSciences that relate to products approved by the FDA, the FDA will take swift and appropriate action to ensure that the drug products available to American consumers are safe and effective," he added.

The FDA's inspection of the GVK BioSciences facility in Hyderabad took place in September 2014, after the European Medicines Agency's (EMA's) inspection of the company. European regulators informed the FDA of their concerns about the clinical part of bioequivalence studies conducted by GVK in Hyderabad, Outsourcing-Pharma reports. "The FDA agrees that non-compliance with good clinical practices is a serious concern, and we support EU member states' actions regarding studies submitted to European authorities," the FDA spokesman said.

India is one of the largest producers of generic drugs sold worldwide, making not only finished medicines but also supplying other drug makers with active ingredients for their products.

Determining which drugs on the EMA list are available in the United States is difficult because the FDA has not identified the products. Several companies with US operations, including Abbott Laboratories, Teva Pharmaceutical Industries, and Mylan, were among those whose products appeared on the EMA list, according to Outsourcing-Pharma. An Abbott spokesman said Abbott does not sell any pharmaceutical products in the US. Mylan and Teva did not respond to inquiries about which of the products banned in Europe are still sold in the U.S., and whether they planned any actions. It remains unclear whether Teva, Mylan or other companies whose drugs appear on the EMA list manufacture any of the listed products under contract for companies that sell them in the United States.

The EMA said its inspection of GVK's Hyderabad facilities found instances of data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appear to have taken place over a period of at least five years. Outsourcing-Pharma reports that GVK has protested the European decision.

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