Johnson & Johnson has removed at least two top managers at its McNeil Consumer Healthcare plant in Fort Washington since the massive April 30 recall of all infant and children's formulations of Tylenol, Benadryl, Motrin, and Zyrtec, a top executive told a congressional oversight panel Thursday.
Colleen A. Goggins, worldwide chairwoman of Johnson & Johnson's consumer health-care group, said the Montgomery County plant would remain closed until at least mid-July, when Johnson & Johnson expects to submit a master plan to the Food and Drug Administration for fixing manufacturing and quality controls that led to the McNeil recall.
"We will not reopen that plant until we meet our own, and the public's, and the FDA's standards for high quality and safety," Goggins said in testimony to the House Committee on Oversight and Government Reform.
Goggins told the panel that J&J had replaced "a number of key quality and manufacturing individuals" in charge of the plant outside Philadelphia and three other McNeil facilities, which manufacture some of the world's best-known brands of over-the-counter medications.
Goggins mentioned the shake-up in testimony to the committee that focused on the FDA's findings preceding the April 30 recall and two other recalls in the previous eight months. Committee members also sharply criticized McNeil for what they called a "phantom recall," a newly disclosed incident in which a contractor was instructed to buy packets of Motrin that did not dissolve properly but not to say the word recall.
Goggins said that since the April recall, J&J had named a new plant manager and new head of quality for the Fort Washington plant, as well as new vice presidents overseeing operations and quality assurance.
Production at the Fort Washington plant, which employs about 1,200 people, was suspended last month, two weeks before a critical report was filed by inspectors for the U.S. Food and Drug Administration. That preliminary report identified 20 problems at the plant, including shortcomings in training, improperly maintained equipment, lack of adequate controls governing product quality and strength, and failure to follow up on complaints.
Thursday's testimony by Goggins and Joshua M. Sharfstein, the FDA's principal deputy commissioner, provided new details about the McNeil plant's voluntary April recall and the events behind it, which Sharfstein said included several years of "growing concerns about the quality of the company's manufacturing process."
Sharfstein said McNeil recalled more than 136 million bottles of the liquid medications, reflecting its estimated 70 percent share of the infant and children's market. The recall, the largest ever for children's medicines, covered all unexpired bottles of the drugs. (For information, go to www.mcneilproductrecall.com)
Sharfstein said the recall and plant closure showed that Johnson & Johnson was finally coming to grips with problems that were drawing an increasingly aggressive response from regulators, culminating in what he called an "extraordinary meeting" on Feb. 19 that brought together McNeil's president, J&J officials, and senior FDA staff.
"The story of this whole episode is that FDA increased the pressure, increased the pressure, brought in the corporate executives, and wound up forcing, I think you'll hear, very major changes in the company's approach to quality," Sharfstein said.
Sharfstein and Goggins said it was unlikely that quality problems with the medications, including contamination with metal particles, had caused harm to the infants or children who took them.
According to the FDA, 775 "adverse events" related to the recalled products were reported between January 2008 and April 30 - a volume the agency does not consider high for such widely used drugs.
Although several hundred additional events are under investigation since the recall, including seven deaths, agency officials still believe it is unlikely the medications are to blame, according to congressional staffers.
Sharfstein said the metal particles, which included nickel and chromium, could be expected to "pass through the gastrointestinal tract." He also downplayed the potential risk from "superpotent" batches of infant Tylenol produced at the plant.
"While there was a potential for higher concentrations of Tylenol per dropper, none of the final products released for sale tested with high levels," Sharfstein said. And even if they had, he said, "the increase in potency would not be expected to cause adverse effects."
Still, Sharfstein told the oversight panel that Johnson & Johnson could face consequences "for its pattern of noncompliance," potentially including criminal penalties.
"Although the public health risk from these quality problems is low, these problems should never have occurred," Sharfstein said.