Reuters ahead on timing of regulator announcements of key Glaxo drug
09.23.2010
Following a tip-off, Reuters was first to reveal on Sept 23 that the U.S. Food and Drug Administration and the European Medicines Agency would both give their verdict later that day on whether to pull GlaxoSmithKline’s controversial diabetes drug Avandia off the market. A decision by the EMA was already scheduled but news that the FDA would make its announcement at the same time worried investors. Glaxo shares fell as much as 2.6 percent on fears of draconian action by both regulators. The FDA confirmed its plans to make a statement 2 hours after the Reuters report. In the event, the EMA suspended the drug while the FDA allowed it to stay on sale with severe restrictions - a difference of approach that had been predicted in a Reuters story on Sept 20, which said Avandia was more likely to be pulled in Europe than the United States.