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Tylenol Recall Shows FDA Needs Greater Authority, Says Rep

Gina-Marie Cheeseman
| Thursday June 3rd, 2010 | 1 Comment

The Food & Drug Administration (FDA) needs “mandatory recall authority” Rep. Eldolphus Towns (D-NY), Chairman of the House Committee on Oversight and Government reform said during a May 27 hearing. The hearing concerned the April 30 recall of children’s Tylenol and other pediatric medicines. During the hearing, the FDA told the committee that McNeil Consumer Healthcare, a division of Johnson & Johnson which manufactured medicine at its Fort Washington, Pennsylvania plant, knew back in 2008 there was a potential problem with one of its Motrin products. Instead of issuing a recall, McNeil sent contractors to stores to buy back the products. (PDF Link)

Johnson & Johnson recalled certain batches of infant and children’s liquid Tylenol, Motrin, Benadryl and Zyrtec on April 30.  A federal inspection report released last month said the plant had many quality control problems, and reported that the company used raw materials with known bacterial contamination to make certain batches of the recalled products. The company may face criminal charges as a result. According to a statement from Dr. Joshua Sharfstein, the FDA’s principal duty commissioner, last week, the FDA is “considering additional enforcement actions against the company for its pattern of non-compliance which may include seizure, injunction or criminal penalties.”

The April recall is the fifth one of McNeil products since last September. In January, the company issued a recall after consumers complained about certain products having a moldy smell. The odor came from a byproduct of a chemical used to treat wooden pallets that leached into products at the company’s plant in Puerto Rico.

“This is yet another example of the need for companies to take full accountability for the quality of their drugs, and the serious consequences that can happen when companies do not do so,” said Deborah M. Autor, the director for compliance at the FDA’s Center for Drug Evaluation and Research, last month during a conference call with reporters.

The FDA itself basically admitted it needs recall authority during the hearing. Sharfstein told the committee having recall authority may have led to a quicker recall after the FDA told J&J that it had “rising concerns” about the manufacturing process at one of McNeil’s plants.

“With other tools, could we have gotten their attention faster?” Sharfstein said. “I think those are fair questions to ask.”

Rep. Diane Watson (D-CA) suggested a clause should be added to a pending food safety legislation that states “anything ingested through the mouth” so drugs are covered. The food safety legislation includes recall authority.

Adding such a clause may not be the best way to proceed. Towns said in his closing statement during the hearing that he intends to introduce legislation to give the FDA recall authority.  Towns added that the FDA “should also have the power to order a halt in drug production.”


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