J&J chief admits lapses in quality control

Reporting from Washington —  The head of pharmaceuticals giant Johnson & Johnson, testifying on the massive recall of its widely used children’s pain relievers, admitted Thursday that “we did not maintain our high quality standards.”

As a result, Chief Executive William C. Weldon said, “children do not have access to our important medicines.”

Weldon told a congressional committee that the company is spending $100 million to fix quality problems that led to last spring’s recall of children’s over-the-counter medications, including children’s Tylenol. He also acknowledged mishandling two other recalls at his company’s McNeil Consumer Healthcare subsidiary.

In one recall, a top Food and Drug Administration official said the agency should have been more aggressive in prodding Johnson & Johnson to get substandard batches of adult-strength Motrin caplets off the market.

The three recalls of over-the-counter medicines highlighted at the hearing are only part of a lengthy list of recent recalls undertaken by Johnson & Johnson. The New Brunswick, N.J., company was once considered a standard-setter for safety.

In the last two months, the company also has pulled contact lenses and hip implants from the market.

The recall of products manufactured at McNeil’s now closed Fort Washington, Pa., factory covered an estimated 136 million bottles involving more than 40 liquid compounds, including market-dominating brands such as Benadryl, Motrin and Tylenol.

Johnson & Johnson estimated that recalls will cost the company $600 million in lost sales, or 1% of its roughly $60 billion in annual sales. The company said it would eliminate 300 jobs as it revamps the Fort Washington facility, which the FDA cited for numerous substandard manufacturing practices shortly before the April 30 recalls.

The FDA so far has not linked a recalled product directly to any serious illness or death.

At least some of the over-the-counter medicine recalls are under federal criminal investigation.

Weldon said he accepted “full accountability” for the problems at the McNeil unit.

In the Motrin recall, Johnson & Johnson hid its attempt to withdraw packets of defective pain reliever, which did not dissolve properly, by hiring a firm to send employees to buy up the medicine in mid-2009, without telling the stores what they were doing.

“This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products,” Weldon said.

For its part, the FDA should have pushed harder in figuring out what Johnson & Johnson was up to and pressuring the company into a public recall, said Joshua Sharfstein, the FDA’s principal deputy commissioner.

The FDA cannot order recalls on its own authority, and Sharfstein said the episode highlighted the need for Congress to give the agency that power.

In the third recall, Johnson & Johnson waited a year before notifying the agency in September 2009 that people reported getting ill from exposure to a musty smell on bottles of Tylenol and other over-the-counter medications.

The smell eventually was traced to a pesticide used to treat wooden shipping pallets.

Weldon said the company began trying to determine the cause of the odor in 2008, but gave up when reports of sickness tailed off, only to pick up again in September 2009.

“We should have determined the root cause in 2008,” he said.

azajac@tribune.com