FRIDAY, May 28 Criminal penalties could be levied against the Johnson & Johnson division responsible for a recent massive recall of pediatric medications, a U.S. Food and Drug Administration official said Thursday.
The FDA is “considering additional enforcement actions against the company for its pattern of noncompliance, which may include seizures, injunction or criminal penalties,” Dr. Joshua M. Sharfstein, the FDA’s principal deputy commissioner, said during a Congressional hearing, The New York Times reported.
Evidence presented at the hearing indicated a history of problems within the company, the newspaper said.
Sharfstein said a pattern of violations in manufacturing and quality-control procedures led the J&J unit, McNeil Consumer Healthcare, on April 30 to recall on more than 136 million bottles of liquid children’s drugs, including Tylenol, Motrin and Benadryl. The medications may have contained inactive ingredients that failed testing, bits of metal or too much active ingredient.
But that recall was not the drug manufacturer’s first quality issue, and lawmakers and regulators are now questioning the company’s integrity, the Times said.
Sharfstein told lawmakers that the company has delayed reporting problems to the FDA, and that in 2008 it quietly removed Motrin from retailers because of suspected problems without informing the FDA, the newspaper said.
“This is something troubling to the agency,” he said. “We think it reflected poorly on the company.”
Another FDA official said the McNeil case has been referred to the FDA’s office of criminal investigation, which works with the Justice Department to uphold laws governing drug manufacturing and marketing and prosecute companies that violate them, the Times said.
Thursday’s hearing was called by the House Committee on Oversight and Government Reform to investigate the recall and determine whether the FDA handled it effectively.
Colleen A. Goggins, the worldwide chairwoman of Johnson & Johnson’s consumer group, admitted lapses at the McNeil unit. “The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable,” she said.
But in defense of the company, Goggins added, “There was never any intent to deceive or hide anything.” She said the pediatric medicines that contained too much of the active ingredient or metal specks were rejected and never reached the marketplace.
The FDA this week said it had received reports of health problems linked to the recalled drugs but had found no evidence that the products had caused the medical issues, the newspaper said.
McNeil is making major changes in its overall operations and has replaced several top executives, Goggins told committee members, some of whom expressed dismay with the company, the newspaper reported.
The action “paints a picture of a company that is deceptive, dishonest and willing to put the health of children at risk,” Rep. Edolphus Towns (D-N.Y.), the committee chairman, told Goggins, according to the Times.