Congress Considers Increasing FDA Recall Authority

June 1, 2010
As the U.S. Food and Drug Administration (FDA) considers criminal charges against McNeil Consumer Healthcare, Congress contemplates giving the FDA more power to force drug recalls.

McNeil is the Johnson & Johnson subsidiary that manufactured the children’s drugs that were involved in a massive recall on April 30.

At a May 27 hearing before the House Committee on Oversight and Government Reform, Chairman Edolphus Towns said he intends to introduce legislation that would give the FDA the power to force recalls, rather than suggest or recommend them.

“One thing we know now is that the FDA needs mandatory recall authority,” said Towns at the hearing. “FDA should also have the power to order a halt in drug production.”

The FDA says McNeil recalled 136 million bottles of children’s medications, and quality-control problems found during an FDA inspection of the company’s Ft. Washington, Pa., facility resulted in warning letters and a complete production shutdown at the manufacturing plant.

In addition, FDA reports finding particulate matter in liquid children’s drugs as well as raw ingredients contaminated with bacteria and drugs containing the wrong dosage of active ingredients.

The agency has received nearly 800 complaints and at least seven reports of deaths. Officials say none of the complaints or deaths have been linked to the recalled drugs yet, but some are still under investigation.

The FDA also alleges that McNeil knew about problems with Motrin as early as 2008 and sent contractors to retail stores to buy the products back. The FDA claims the McNeil contractors told retailers keep quiet about the recall.

At the Congressional hearing, Colleen Goggins, worldwide chairman of Johnson & Johnson’s consumer group, said the company has made “significant changes to leadership” impacting the management of manufacturing and quality control at McNeil’s Puerto Rico and Fort Washington facilities.

FDA’s concerns about quality problems in pharmaceutical manufacturing extend beyond the McNeil recalls. A recent report in USA Today indicates that more than 40 drug manufacturers have received warning letters from the FDA since January 2009. FDA inspections reportedly uncovered the use of contaminated equipment and ingredients as well as drug companies’ failure to respond to consumer complaints and properly test drugs for strength and purity.

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