FDA: Expect more early warnings

The FDA is warning consumers to expect more communiques about drug side effects. As we noted last week, the number of "early communications" has increased recently, reflecting a new policy of alerting the public to possible problems earlier than in the past. The idea is to air info early, but make clear that any safety problems haven't yet been proven.

FDA deputy commissioner Janet Woodcock said the agency is finding more side effects because last year's FDA reform and funding law gave it the authority and a bit of money to look at after-market drugs. Before that, the agency mainly focused on drugs in the approval pipeline.

If you look at The Wall Street Journal's story on the additional early warnings, though, it seems that the stepped up warning schedule is as much about image as anything. Agency chief Andrew von Eschenbach is quoted saying that data shows an "erosion of trust" among agency observers. "Perhaps because they need to better understand and appreciate what we are doing people's confidence has been eroded." And Woodcock echoed that sentiment: "Consumers will know we are on the case."

- read the story in the Wall Street Journal

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