Johnson & Johnson let public down, chief to testify

When Johnson & Johnson chief executive William C. Weldon testifies to Congress on Thursday, he plans to say his company "let the public down" with mistakes that led to a series of embarrassing recalls, including the massive pullback of more than 140 million bottles of Children's Tylenol and similar products made by McNeil Consumer Healthcare, J&J's troubled Fort Washington subsidiary.

But Weldon will also face tough questions about the company's seeming effort to dodge additional embarrassment - including via what one congressman dubbed the "phantom recall," in which "mystery shoppers" hired by a contractor were sent into 4,500 stores to buy back eight-pill vials of defective Motrin.

In testimony readied for his first appearance before the House Committee on Oversight and Government Reform, Weldon said the "episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective product when they arise."

The "phantom recall" first became a public issue at a May hearing of the same committee, which is trying to determine what went wrong at McNeil and why problems were not identified and addressed earlier by the Food and Drug Administration.

In numbers of units affected, the McNeil recall of about 40 liquid versions of Tylenol, Motrin, Benadryl, and Zyrtec was the largest in FDA history. McNeil and FDA officials have both described the recall as precautionary, saying that various defects - including over-potency and contamination with metallic particles - were unlikely to harm any infants or children.

Even so, the company recalled six million bottles of the drugs from stores, in some cases emptying entire shelves that reflected its estimated 70 percent share of the infant and children's market. It also advised consumers to return or destroy an additional 136 million bottles that had already been purchased - all unexpired bottles of its products.

All the over-the-counter drugs were made at the Fort Washington plant, which McNeil shut before the April 30 recall. Although McNeil first said no competing products were affected, in late May the FDA announced a recall of four versions of PediaCare also produced at the facility.

In his written testimony, Weldon said J&J was investing $100 million in upgrading the Fort Washington plant and other McNeil operations.

"When complete, it is fair to say that the Fort Washington facility will represent the state-of-the-art in medicine production," Weldon said. "The facility will not open until we are confident that we can make McNeil products to the high quality standards that the public, Congress, and the FDA rightly expect from us."

Weldon's testimony, while echoing apologies he has made in recent interviews, will follow months of silence on the problems at McNeil, one of about 250 companies in the huge J&J empire.

Company officials have been largely tight-lipped about the problems or their plans in Fort Washington. In July, they said they would eliminate "about 300 of the over 400 positions" at the facility, and estimated that the plant would be closed "at least until the middle of next year," a spokeswoman said.

Weldon said McNeil expected to begin shipping "one of McNeil's children's medicine products" to customers starting next week, after "working closely with the FDA and our Canadian affiliate."

He did not identify the product, but said, "We expect to distribute a total of four million bottles in the United States by the end of the year."