FDA Mulls 'Criminal Penalties' Against J&J Unit

May 28, 2010
Government has concerns about the quality of the company's manufacturing process which has led to numerous recalls

Following its recall of millions of bottles of liquid childrens Tylenol and other pediatric medicines, authorities are considering "criminal penalties" against a unit of Johnson & Johnson, an official said on May 17.

The actions against McNeil Consumer Healthcare came after growing concerns about the quality of the company's manufacturing process, which had led to numerous recalls, the official from the U.S. Food and Drug Administration said.

Aside from ongoing investigations into its manufacturing operations, the FDA "is also considering additional enforcement actions against the company for its pattern of non-compliance, which may include seizure, injunction or criminal penalties," FDA principal deputy commissioner Joshua Sharfstein said.

He was testifying at a congressional hearing on the circumstances surrounding the recall of the popular infant and childrens medicines produced by McNeil.

The company announced on April 30 a voluntary recall of more than 136 million bottles of 40 variations of childrens medicine, including such widely used products as Childrens Tylenol, Childrens Motrin, Childrens Benadryl and Tylenol Infants Drops.

The recall was carried out because of production problems at McNeil that affected the quality, purity and potency of the medicine, the hearing was told.

McNeil received dozens of consumer complaints about foreign particles in childrens medicine, which were later confirmed by the company. In addition, tests at the plant showed that three batches of Infants Tylenol were found to be "super potent," meaning that they contained an overdose of the active ingredient.

McNeil's production of childrens medicine was shut down by the company and a month later it remains closed amid the FDA probe.

Colleen Goggins, chairman of the consumer group of Johnson & Johnson, testified that McNeil and its outside consultant were in the process of developing a comprehensive action plan on quality improvements. McNeil will share the plan with the FDA by July 15, Goggins said.

Congressman Edolphus Towns, chairman of the House Committee on Oversight and Government Reform that held the hearing, said at the end of the meeting that "there are still unanswered questions." For example, according to Johnson & Johnson, none of its contaminated products had any adverse health effects but the FDA testified that the issue of whether any of the products caused deaths was still being investigated, he said.

"This is an issue of trust," he said. "When parents and grandparents give these medicines to their children, they want to be confident that they are not harmful."

Copyright Agence France-Presse, 2010

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