European watchdogs pull Mylan, Abbott generics on contractor's data problems

Here's another black mark against the pharma industry in India. European regulators are barring a slate of generic drugs whose approvals relied on data generated by India's GVK Biosciences. The treatments weren't named, but they include products sold by a variety of drugmakers, including U.S.-based Mylan and Abbott Laboratories ($ABT).

Drug watchdogs in France, Germany, Belgium and Luxembourg have suspended marketing on the drugs, citing "anomalies" in electrocardiograms handled by GVK employees, Reuters notes. According to a document from the European Medicines Agency, inspectors found that a number of electrocardiograms were falsified as part of 9 different approval studies.

"These falsifications cast doubts on the authenticity of all other clinical records of these 9 trials," the EMA document states, going on to say, "The systematic nature of the falsifications of electrocardiograms, the extended period of time during which they took place and the number of members of staff involved highlight critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad."

German regulators are investigating 176 approvals granted to 28 different drugmakers, and have asked those companies to stop distributing the drugs involved until new data can be generated.

GVK Bio says it's disappointed that authorities cast doubt on the drug approvals. After questions were raised by Europe's Committee for Medicinal Products for Human Use (CHMP), the company strengthened its operating procedures, and those changes were approved by regulators, it said.

"We at GVK BIO believe that the studies conducted are in accordance with the [Good Clinical Practice] guidelines," the company said in a statement posted on its website. "[W]e honor the conclusion made by CHMP and are working with our clinical development customers to provide new data that meets all regulatory requirements."

The regulators say they are weighing the data on these drugs and will decide by January whether to let them return to market at that time or require brand-new studies first. Some drugmakers involved have offered to conduct new studies, French watchdogs tell Reuters. GVK Bio tells the news service that it has already earmarked up to $6.5 million for new studies.

The data snafu follows a series of problems with pharma manufacturing operations in India, one of the world's fastest-growing drug markets. Since Ranbaxy Laboratories, India's largest drugmaker, was discovered faking testing data on drugs more than 5 years ago, the FDA has stepped up its inspections in the country, which has long been proud of its role as a provider of generic drugs to the rest of the world.

Now, Ranbaxy's regulatory problems persist, even to the point of blocking its copies of several top brands, including AstraZeneca's ($AZN) Nexium. Some of India's other large drugmakers, including Wockhardt and Sun Pharmaceutical, have also had their plants banned from shipping to the U.S. Just last month, Cadila Pharmaceuticals was cited for selling potentially contaminated drugs. FDA enforcement problems have also affected Indian producers acquired by U.S.-based companies, including Orchid Pharmaceuticals, bought by Hospira ($HSP) earlier this year.

- see the EMA document
- read the GVK Bio statement
- get more from Reuters

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