US FDA's more proactive recall approach?

13 April 2009

The US Food and Drug Administration has demonstrated a more robust approach to the regulation of food and medicines since the appointment  of Joshua Sharfstein as Deputy Commissioner (Marketletters passim). The  New York Times reports that he has been put in charge of the agency  while Margaret Hamburg's nomination as Commissioner awaits confirmation  by the Senate, a process which could be delayed if there is opposition,  particularly along partisan lines, as has occurred with recent  appointees.

Mark Senak, an expert on pharmaceutical marketing writing on his Eye on  FDA blog (www.eyeonfda.com), suggests that the recent product recall  of pistachios, where the agency did not wait for any reports of illness  to demand that shelves be cleared. By contrast, a tomato recall in 2008  and ongoing issues involving peanuts were seen to drag on because the  FDA reacted to "where the evidence, or indications of evidence,  pointed," Mr Senak said. He warns that the more proactive approach could  be carried over to a future drug recall with "evidence of conditions  that could make people ill [becoming] the basis for action, rather than  evidence of illness itself," and he predicts that "large-scale recalls  may be undertaken with more frequency in the future."

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