A recent FDA inspection of contract research organization GVK Biosciences’ Hyderabad, India, plant turned up no evidence of safety or efficacy concerns with US-bound generic therapies, a finding that is in sharp contrast to initial conclusions reached by European inspectors.
Several EU countries last month revoked marketing authorization for generic therapies tested at the GVK plant after France’s medicines agency alleged that its May inspection found electrocardiograms (ECGs) of volunteers were falsified in all nine clinical trials reviewed.
The EMA currently is reviewing the findings, and is expected to issue a recommendation to member countries in January.
The FDA inspectors, however, turned up no such issues in a September inspection, the agency said. The FDA added that it supports the EU’s marketing authorization revocations, and promised swift action should any issues come up from GVK affecting U.S. products.
For its part, GVK has asserted its therapies are safe, pointing to the purely precautionary nature of the authorization revocations, while blasting the reported findings of the French inspection.
Specifically, the findings that ECGs were falsified to make one volunteer patient appear to be several patients are purely subjective, GVK said. The company’s employees would have no rationale to falsify the data because it would not save time, money or effort, it added.
Furthermore, the results from the ECGs should not reflect on generic bioequivalence testing, GVK said. The ECGs in question were performed on a patient checking out from a clinic, and are not part of any international clinical guidelines, GVK argues. — Bryan Koenig