The questions about quality problems at the Johnson & Johnson unit that makes such staples of the medicine chest Children's Tylenol and Motrin for adults just won't go away.
Top managers from Johnson & Johnson will have to answer for the company's handling of problems with Children's Tylenol and Motrin.
This morning, J&J CEO Bill Weldon will make his first appearance before a House panel that's investigating the company's handling of problems traced to factories in Pennsylvania and Puerto Rico. He missed a May hearing due to back surgery.
In his prepared testimony, Weldon concedes, "I know we let the public down. We did not maintain our high quality standards, and as a result, children do not have access to our important medicines."
Lax quality control and tardy, incomplete investigations of complaints from customers lie at the heart of the problems at the company's McNeil unit, maker of over-the-counter drugs.
McNeil's Fort Washington, Pa., factory, where liquid medicines for kids were made, remains closed. Some 135 million bottles of Children's Tylenol and other pediatric remedies were recalled, and the products have been off the market since late spring.
Weldon says the company will start shipping some kids' medicines again next week. About four million bottles from a Canadian plant could be available in the U.S. by the end of the year.
As the investigation into J&J has deepened, the focus has shifted to how the company handled recalls of products that didn't meet quality standards. Some batches of adult-strength Motrin didn't dissolve the way they were supposed to. That was a problem that could leave some of the medicine too weak.
But how J&J then hired companies to surreptitiously buy up the Motrin from retailers without revealing the issue — a so-called "phantom recall" — has become a cause for concern.
Just listen to the Food and Drug Administration's Dr. Joshua Sharfstein, principal deputy commissioner, who will testify before the panel chaired by Rep. Ed Towns (D-NY) today. In prepared remarks, Sharfstein says, the agency raised concerns with J&J early this year about the action "because it seemed strange that the company had paid a contractor to go into retail stores across the country to purchase all available product while acting like a regular customer, and not disclosing whether it was a recall."
Sharfstein notes that without going to court the agency can't order a recall, but must instead rely on companies to undertake them voluntarily. Rep. Towns is pushing legislation to put the recall power in FDA's hands, and Sharfstein supports the change:
In this case, if FDA had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred.
J&J's Colleen Goggins, head of the company's consumer businesses, will have some explaining to do. Previously, she'd testified that she wasn't aware of the company telling a contractor to quietly buy up the Motrin.
Since then, her prepared testimony says, she's seen the instruction that McNeil gave to a contractor telling it not to talk about reasons for the action. "Based on what I have learned since May, I believe that McNeil should have handled things differently."