Tylenol, Motrin, Benadryl recalls spur criminal probe, Congress is told

Tylenol, Benadryl, Motrin recalls spur criminal probeTop Food and Drug Administration officials told a congressional committee today that Johnson & Johnson, the venerable manufacturer of Children's Tylenol, Motrin, Benadryl and other children's medicines, demonstrated a pattern of failing to control product quality at its McNeil Consumer Healthcare unit and is under criminal investigation.

They also revealed that while the company on April 30 recalled 40 varieties of infant's and children's liquid medicines, closed a plant and is now doing better, its production practices remain under scrutiny. They announced that the FDA has referred evidence about the company's actions to the agency's criminal investigative unit for possible criminal prosecution

"There was a corporate culture of non-compliance. It was system wide. This is a company that had major problems with compliance," Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner told members of the House Oversight and Government Reform Committee.

Sharfstein made clear that while the FDA had extensive concerns about McNeil's procedures and policies, there is no evidence that any products actually hurt consumers, though the investigation continues.

"We consider these quality problems and we want to fix them before we are counting the hospital visits," he said. He described a series of incidents in which manufacturing problems at McNeil produced medicines with "super potency," contamination or other problems and McNeil, even when it caught the problems, didn't properly notifying the FDA.

Sharfstein noted a 2008 incident in which McNeil became aware that over-the-counter medicines being produced at a Puerto Rico plant carried a "musty odor" but neither followed up, nor notified the FDA for nearly a year. McNeil eventually recalled medicines produced when it was determined that the odor was from insecticide used on wood pallets containers were stored on-insecticide that posed a hazard of nausea, stomach pain, vomiting or diarrhea.

The committee's chairman Edolphus Towns, D-N.Y., said that in another instance the committee learned that after finding problematic Motrin product in 2008, McNeil instead of notifying the FDA or recalling the product, sent contractors out to stores to try to buy out the product, telling them "not to mention" a recall.

Sharfstein said the problems at McNeil were serious and frequent enough that the FDA called an "extraordinary meeting" in February, not with McNeil, but top officials of its parent company, Johnson & Johnson.

"We went over the head of [McNeil's] corporate people to express our concerns," he said. "This was a meeting about a culture of complaints."

Colleen A. Groggins, worldwide chairman of Johnson & Johnson's consumer group, said quality control now has clear corporate attention and the company has made major changes in personnel and procedures. She also noted that the recall has prompted some confusion.

'"The entire incident is deeply embarrassing to Johnson & Johnson," she said. "We take our commitment to consumers seriously.

"The quality and process issues that we found at McNeil, those which led to [the latest] recall and others are unacceptable," she said. "On behalf of Johnson & Johnson I apologize to the mothers, fathers and caregivers for the concern and inconvenience of this recall."

Still, she called any danger to consumers, "remote." She said there have been no reports of consumers being hurt. She also said the Motrin incident resulted from a small portion of the drug sold only in gas stations not being fully effective and the FDA was aware of the hiring of contractors to remove it.

Rep. Dennis Kucinich, D-Ohio, sharply questioned Groggins, noting several incidents in which young children died after showing symptoms that could be attributable to contamination.

"We believe that there are no serious medical events associated with the recall of these products," she said.

Other congressmen said they were worried the incident could demonstrate problems in the nation's drug supply. They also questioned whether the FDA should get new authority to recall drugs.

"We are talking about a market leader whose creed was all about products and manufacturing," said Rep. Darrell E. Issa, R-Calif., the committee's ranking Republican. "They have disappointed us."

He said that if Johnson & Johnson and McNeil were having problems, he could only wonder about problems at offshore producers.

Towns also expressed concern.

"When questions are raised about whether children's medicine is safe, parents need immediate answers," he said. "Almost every household in this country has these products in their medicine cabinets. And everyone has the same questions: Are these products safe and what are we doing to ensure safety in the future."
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