Drugmakers split as demands for open data mount | Reuters

abernard102@gmail.com 2013-05-09


"Big data is emerging as a big headache for the drug industry as regulators and advocates push for greater transparency on information from clinical trials, leaving companies split over how to respond. GlaxoSmithKline Plc (GSK.L) this week set up a new online system to provide researchers with access to clinical data about its medicines, but some rivals have turned to their lawyers instead. The issue has triggered a court battle in Europe, where the European Medicines Agency (EMA) has set alarm bells ringing with plans to release previously secret trial data submitted as part of the new drug application process. Margaret Hamburg, head of the Food and Drug Administration (FDA), told the Reuters Health Summit this week that U.S. laws prevented similar disclosure in the United States but the agency was nonetheless looking to increase transparency. 'I do think there are some ways in which we should do more,' she said. 'It would be beneficial if we could shine a bit more light on why we don't approve a product because at the present time that information is not posted in the same way as when we do an approval.' The EMA's plans to release clinical trial data have been slammed as irresponsible by the Pharmaceutical Research and Manufacturers of America lobby group, which fears it could harm business and undermine incentives for research. That position chimes with U.S. drugmakers AbbVie Inc (ABBV.N) and InterMune Inc (ITMN.O), both of which have challenged the release of data about their drugs, and last week won a temporary injunction against the EMA. [ID:nL6N0DH3A5] Still, many drug companies reckon the clamor for greater openness won't go away, given past drug safety scares and the demands from independent researchers for access to data that allows them to stress-test industry claims about medicines ..."



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Open Access Tracking Project (OATP) ยป abernard102@gmail.com


oa.medicine oa.new oa.data oa.policies oa.comment oa.government oa.usa oa.europe oa.biomedicine oa.clinical_trials oa.ema oa.fda oa.glaxosmithkline oa.abbvie oa.intermune oa.pharma

Date tagged:

05/09/2013, 12:38

Date published:

05/09/2013, 08:38