Following Revelations of ‘Flawed Studies’ in Clinical Trials, EMA Recommends Suspending Drugs; Many of Which Belong to Novartis AG and Teva

Following Revelations of ‘Flawed Studies’ in Clinical Trials, EMA Recommends Suspending Drugs; Many of Which Belong to Novartis AG and Teva July 25, 2016
By Alex Keown, BioSpace.com Breaking News Staff

LONDON -- The European Medicines Agency recommended suspending the sale of dozens of generic medications, including several made by Novartis AG and Teva , following concerns over “flawed” studies conducted at a research facility in India.

The EMA recommendation, issued July 21, followed an inspection of the Semler Research Center in Bangalore, India, by the U.S. Food and Drug Administration. According to a statement issued by the EMA, that investigation revealed bioequivalence studies being conducted at the facility were not being done properly, with problems including the substitution and manipulation of subjects’ clinical samples. In addition to the FDA, the World Health Organization also raised concerns over the integrity of the research being conducted at the facility.

“The findings from FDA and WHO inspections call into question the quality management system in place at Semler, and thus on the reliability of the data of all bioequivalence studies, including those used to support marketing authorization applications in the EU,” the EMA’s statement reads.

Bioequivalence studies typically form the basis for approval of generic medicines, the EMA said.

The EMA said it recommended the medicines it was looking to suspend and could be re-evaluated with bioequivalence studies conducted using alternative data. Although some of the medicines turned out by Semler have been approved, the EMA said there is currently no evidence of harmful substances or a lack of efficacy “with any medicine approved on the basis of studies conducted at Semler.”

In April, the FDA issued a statement notifying companies seeking New Drug Applications that clinical and bioanalytical studies conducted by Semler would not be accepted due to questions of data integrity. Much like the EMA, the FDA called for drug companies to redo the bioequivalence studies at another facility.

The review of the Semler site was initiated in April at the request of multiple countries in the EU, including the United Kingdom, Spain, Germany, Denmark, the Netherlands and Spain. The review was carried out by the Committee for Medicinal Products for Human Use, the committee responsible for preparing the EMA’s opinions on questions concerning human medicines.

The EMA issued a long list of medications it was calling to suspend, including multiple versions of Erlotinib-based medications developed by Teva and Sandoz. A full list of drugs recommended for suspension was released by the EMA.

The problems discovered at the Semler site is not the first time Indian contract research organizations have come under scrutiny by regulators. India has seen its share of troubles with the administration of some medications, as well an abundance of counterfeit medications, in part due to an overburdened healthcare system, especially in smaller towns. In 2008, the U.S. Food and Drug Administration banned the sale of medicine from Indian drug maker Ranbaxy due to manufacturing violations. In March 2015, the FDA issued a warning letter to Apotex over manufacturing violations at a plant in Bangalore, India. In its letter, the FDA said lab workers failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

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