Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales
Last week, a European ban took effect on 700 generic medicines that were approved based in part on what regulators called flawed clinical studies conducted at GVK BioSciences, a contract research organization (CRO) based in Hyderabad, India.
But the US Food and Drug Administration (FDA) isn’t taking any action on products sold here that included data from GVK’s studies in their applications, apparently because the FDA’s own inspection of the plant didn’t raise the same concerns.
The FDA has identified about 40 pharmaceutical product applications that contain GVK clinical study data between 2007 and 2012. The agency doesn’t believe there’s 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 this week.
He added: “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.”
European concerns
The FDA’s inspection of the GVK BioSciences facility in Hyderabad took place in September 2014 and was subsequent to the European Medicines Agency’s (EMA’s) inspection of the company.
European regulators made the FDA aware of their concerns about the clinical part of bioequivalence studies conducted by GVK in Hyderabad.
“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.
The drugmakers
Pinpointing which drugs on the EMA list are available in the United States is difficult. The FDA isn’t identifying 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.
An Abbott spokesman said Abbott doesn’t sell any pharmaceutical products in the US. Spokespeople for Mylan and Teva didn’t respond this week to inquiries about which of the products they made that are banned in Europe are still sold here, and whether they planned any actions.
It also is unclear whether Teva, Mylan or other companies whose drugs appear on the EMA list contract manufacture any of the listed products for other companies that sell them in the United States.
The EMA said its inspection of GVK in Hyderabad 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. GVK has protested the European decision. The list of 700 medicines includes different formulations and strengths.
