U.S. FDA cites ‘systemic’ problems at J&J

Last month’s recall of Johnson & Johnson’s liquid children’s medicines is just the latest evidence of what U.S. health regulators say are systemic quality problems at the healthcare company and its McNeil consumer unit.

The U.S. Food and Drug Administration “has had growing concerns about the quality of the company’s manufacturing process” that “have led to a number of unsatisfactory inspections and consumer recalls,” Deputy Commissioner Joshua Sharfstein said in testimony for a congressional hearing on Thursday.

FDA inspectors have been checking McNeil Consumer Healthcare’s facilities increasingly often and in February took the “extraordinary” step of meeting with management at its J&J parent company, Sharfstein said in prepared remarks for the U.S. House Oversight and Government Reform Committee.

“Although the public risk from these quality problems is low, these problems should never have occurred,” Sharfstein wrote, “and the (manufacturing) failures that caused them were unacceptable.”

The hearing comes amid what is believed to be the largest known recall of over-the-counter children medicines, with roughly 70 percent of the market for such products pulled from store shelves.

In late April, J&J announced a nationwide recall of its popular Children’s Tylenol pain reliever. Altogether, more than 40 varieties of liquid medicines, including pain drug Motrin, and allergy medicines Benadryl and Zyrtec, were recalled.

Agency inspectors in late April cited McNeil’s Fort Washington, Pennsylvania, plant for a variety of lapses that included bacterial contamination of ingredients, filthy equipment and the potential for medicines to be too potent.

Sharfstein said the FDA had cited similar problems at McNeil facilities before 2009, but added that the company generally resolved the issues.

But in May and June 2009, agency inspectors again identified multiple problems, including the “failure to meet its own standard for quality” in one ingredient for nonprescription liquid medications, Sharfstein wrote.

The House committee is investigating the recall and trying to shed light on J&J’s lapses as well as the FDA’s oversight. The head of the U.S. Senate health committee has also questioned the FDA, but is not yet seeking a public meeting.

In separate testimony, Colleen Goggins, worldwide chairman of J & J’s consumer group, defended the company’s actions. She told lawmakers that J&J worked quickly to ensure recalled products were removed from store shelves and informed the public about the problems.

Even before the most recent recall, McNeil and J&J have been working to improve product quality, she wrote. They will also “expend whatever resources are necessary to ensure that this facility provides, once again, high-quality medicines.”

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WASHINGTON (Reuters)