Despite the European Medicines Agency (EMA) placing a ban on approximately 700 drugs because of flawed studies, the U.S. Food and Drug Administration (FDA) will continue to allow the drugs to be sold in the United States.
The EMA’s decision occurred following its discovery that GVK BioSciences had flawed many clinical studies that were used as evidence of the safety of hundreds of generic drugs. The FDA, while saying it supports the EMA’s decision, will not band the sale of the effected drugs in the United States.
According to Outsourcing-Pharma:
The FDA’s own inspection of the GVK plant did not 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 does not believe there’s any danger to patients from these products, based on its own inspection of GVK’s facilities.
“We have identified the U.S. 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 U.S.,” the FDA has stated. “If the FDA identifies issues concerning GVK BioSciences that relate to products approved by the FDA, the FDA will take swift and appropriate actoin to ensure that the drug products available to American consumers are safe and effective.”
