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Sharfstein Says Recall Authority Could Prevent Phantom Recalls

October 22, 2010
A senior FDA official told lawmakers that having mandatory recall authority power could have prevented Johnson & Johnson’s (J&J) so-called phantom recall of defective Motrin.

The events of J&J’s recall raise “important questions about the current voluntary recall system,” FDA Principal Deputy Commissioner Joshua Sharfstein told the House Oversight and Government Reform Committee. “If FDA had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred.”

But Rep. Darrell Issa (R-Calif.) reminded Sharfstein that the FDA failed to use its current authorities to their full extent. “No amount of authority makes up for failure to do the job you already have authority for,” Issa said.
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