Healthy Skepticism Library item: 13068

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Publication type: news

Goldstein J.
U.K. to Tighten Pharma Rules as Glaxo Avoids Prosecution
The Wall Street Journal 2008 Mar 6
http://blogs.wsj.com/health/2008/03/06/uk-to-tighten-pharma-rules-as-glaxo-avoids-prosecution/?mod=yahoo_hs

Full text:

GlaxoSmithKline won’t be prosecuted for its handling of safety data on the antidepressant Seroxat (sold in the U.S. as Paxil), U.K. regulators have decided. But the government isn’t pleased with the way the company acted in the case, and it plans to push for changes in the law as a result.

A four-year investigation by Britain’s Medicines and Healthcare Regulatory Authority (MHRA) found that Glaxo held back evidence that suggested the drug increased the risk of suicidal behavior in people under 18. The company won’t be prosecuted because the law in the U.K. is unclear on when or whether companies are required to report such findings to regulators, the Guardian reports.

But the public health minister said new legislation will be introduced later this year requiring drug companies to share data with regulators when clinical trials point to possible safety problems.

Glaxo, which a few years back settled a lawsuit brought by New York’s AG over how the company handled Paxil data, has consistently said it handled the data appropriately.

“We firmly believe we acted properly and responsibly in first carrying out this important clinical trials program and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behavior in patients under 18,” said Alastair Benbow, Medical Director for GlaxoSmithKline Europe, told the AP.