An agency officer tells the House oversight committee that it had advised Johnson & Johnson to enhance practices way ahead of the recall of kids’ Tylenol and other drugs.
The Food and Drug Administration distressed by quality-control issues with children's Tylenol and other Johnson & Johnson medicines, poked senior Company officials last February to enhance manufacturing and respond quickly to customer grievances, a senior agency executive told a congressional jury on Thursday.
However, assured enhancements did not arrive quickly enough, and it was not till April 30 that the company, under FDA duress, declared the biggest recall of pediatric over-the-counter medicine in history.
Joshua Sharfstein, the FDA's Principal Deputy Commissioner told the House Oversight and Government Reform Committee that Johnson & Johnson is under analysis by FDA's criminal division to find out whether any of its inappropriate actions warrant trial.
Sharfstein described Johnson & Johnson's Company culture as sluggish in reaction and not always frank regarding its movements.
Besides last month's recall, the Company had to withdraw 8 million bottles of kids' medicines from the market in September 2009 due to a quality-control problem, and a large number of million bottles of medicines owing to grievances of a musty smell, which some customers said made them unwell.