WASHINGTON (AP) – Johnson & Johnson said it has hired an outside consulting firm to help fix manufacturing problems that triggered a massive recall of children’s medicines and which have drawn ire from federal lawmakers and regulators.
The maker of Tylenol, Motrin and other medications laid out plans to restructure its manufacturing operations in the wake of the latest in a series of recalls that have tarnished the company’s household brands. In a posting to employees on its Web site, J&J’s McNeil Consumer Healthcare unit said it will share its action plan with the Food and Drug Administration by mid-July.
“McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us,” reads the statement.
The announcement comes on the same day the FDA ratcheted up scrutiny of J&J, issuing the company a warning letter about lax procedures at a plant that makes sterilization tools.
Colleen Goggins, J&J’s president for consumer products, is scheduled to testify before a House committee on Thursday about a slew of manufacturing problems that triggered the recall of more than 40 medicines last month.
FDA inspectors prodded J&J to recall the children’s medications after discovering the company had not looked into dozens of consumer complaints about “black or dark specks” in Tylenol and other products. FDA’s deputy commissioner is also scheduled to testify Thursday.
J&J, which is based in New Brunswick, N.J., has long enjoyed a sterling corporate image, even ranking first place last year in a poll of company reputations.
That positive image is due in part to J&J’s handling of past product recalls.
The company’s response to a cyanide tampering scare in Chicago that killed seven people in 1982 is considered a textbook example of how to deal with a brand crisis.
J&J had its sales force remove 264,000 Tylenol bottles from Chicago area stores; consumers also were urged to return any Tylenol they had for a safe bottle, and prompt alerts from J&J and the FDA kept the public informed.
But now congressional lawmakers are blasting the company’s competence and integrity.
“It is a moral outrage for a company specifically marketing is products for children to allow a culture of neglect and irresponsibility to taint the medicines that parents and physicians trust to help children get well,” said Rep. Darrell Issa, R-Calif., ranking member on the House Committee on Oversight and Government reform.
On Monday the chairman of the Senate’s health committee issued a letter to the FDA, seeking more information about J&J’s recall.
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