Washington: Johnson & Johnson disappointed consumers in recalling millions of bottles of popular children’s medicines, but products should be back on store shelves soon, the company’s chief executive said in documents released on Wednesday.
In prepared testimony released ahead of a congressional hearing, chief executive William Weldon said its McNeil consumer unit will start shipping nearly 1 million bottles of one product next week and hopes to distribute 4 million bottles by year’s end.
Although Weldon did not say which product would be back on the market, his announcement comes as a surprise since the recalled medicines were not expected back on store shelves at least until mid-to-late 2011.
His statement comes ahead of Weldon’s first major public appearance since the recalls, at a House of Representatives Oversight and Government Reform Committee panel on Thursday.
“We let the public down,” Weldon said. “We did not maintain our high quality standards, and as a result, children do not have access to our important medicines.
“I accept full accountability for the problems at McNeil, and I will take full accountability for fixing them.”
Since the April 30 recall that saw 40 popular medicines such as Children’s Tylenol pulled from store shelves, J&J has “undertaken significant improvements at McNeil’s facilities,” Weldon said, adding that it is spending $100 million to do so.
Morningstar analyst Damien Conover said the new shipment is good news, given that Wall Street had not expected the affected liquid medicines back on the market until well into 2011.
J&J has said its Fort Washington, Pennsylvania, plant, which made the 135 million bottles recalled in April, would not reopen until the second half of next year.
The 4 million bottles is “still kind of scratching the surface of where they were before but it’s a good start,” Conover said.
Motrin ‘Phantom´ recall
As far as the controversial so-called “phantom” recall last year of a faulty adult version of Motrin, J&J’s Weldon said the company “should have handled things differently.”
Lawmakers are expected to grill Weldon over the separate 2009 incident in which J&J’s McNeil hired outside contractors to purchase certain lots of Motrin that had problems dissolving. E-mails between the companies showed workers were told to act like normal customers to avoid attention.
At issue is whether McNeil acted with the Food and Drug Administration’s approval for the “phantom” recall rather than publicly issuing a formal recall. J&J has said there was no formal agreement with the FDA, but that the agency was aware of its actions. FDA has denied that claim.
In separate testimony issued late Wednesday, FDA deputy commissioner Joshua Sharfstein said while McNeil notified the FDA about the purchases, it “did not fully disclose the likely scale of the action or the way that the company was intending to proceed.”
Contractors visited 4,100 stores in 40 states, according to the committee.
Sharfstein said the incident highlighted FDA’s inability to force recalls and its reliance on voluntary company actions. He also acknowledged that FDA took too long in asking for the Motrin recall after it fully learned of the company’s plans.
“In this case, 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,” Sharfstein said.
Committee Chairman Edolphus Towns is pushing legislation giving the FDA greater recall power.
J&J’s Weldon said McNeil “acted with good intentions” in hiring contractors to help pull the product off store shelves, but that was not the way J&J companies should handle defective products.