From the WSJ health blog:
The FDA was a bit quick on the trigger in making public some documents about AstraZeneca’s Seroquel this morning.
The agency posted briefing documents on its Web site for an advisory committee meeting coming up on Wednesday to discuss AstraZeneca’s application for approval of an extended-release version of Seroquel for generalized anxiety disorder and major depression. Later, the documents were taken down.
Since some people had already gotten their hands on the documents before they disappeared, AstraZeneca responded by posting them on its own site “to ensure that all investors have access to the information contained in the previously released FDA briefing materials,” the company said.
The FDA also returned the documents to its site. FDA spokeswoman Sandy Walsh tells the Health Blog that the materials “were inadvertently posted by the FDA” the first time around. Normally, such documents are made available 48 hours before the meeting, she explains. But given they went up early, the documents “should have remained posted,” Walsh says. “We regret any confusion that may have resulted.”
As for the documents’ contents, Jennifer Corbett-Dooren of Dow Jones Newswires managed to get this article done amid the snafus. The FDA expressed concern about expanding use of Seroquel to a wide population amid possible increased risk of heart problems, Corbett-Dooren reports.