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UK regulators deny claims that their access to oseltamivir trial data was insufficient

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3966 (Published 18 June 2013) Cite this as: BMJ 2013;346:f3966
  1. Adrian O’Dowd
  1. 1London

The main regulators of drugs in the United Kingdom have denied that they had insufficient access to clinical trial data on the antiviral oseltamivir from its manufacturer, despite concerns about missing data.

Witnesses appearing before the parliamentary Public Accounts Committee said, however, that the current system allowed drug companies to withhold some trial data.

MPs on the committee held an evidence session on 17 June as part of their inquiry into clinical trials and Tamiflu, Roche’s branded form of oseltamivir, which had been used to treat pandemic flu.

The inquiry was prompted by a report published last month by the National Audit Office, which looked at drug regulators’ access to all the clinical trial evidence when licensing oseltamivir and whether the Department of Health for England stockpiled the drug on the basis of clinical evidence.1

Between 2006-07 and 2012-13 the department bought nearly 40 million units of oseltamivir, costing £424m (€495m; $665m). But only 2.4 million units were consumed, mostly during the flu pandemic in 2009-10, and over the same period …

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