FDA admits weak oversight in tainted wipes review

FDA admits weak oversight in tainted wipes review

Federal Food and Drug Administration officials have admitted to U.S. senators that they should have taken stronger action to stop a Wisconsin firm from making and distributing medical products potentially tainted with life-threatening bacteria . The contaminated products have been blamed in lawsuits for serious infections and the death of a 2-year-old child.

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Instead of simply holding a meeting last August with officials from H&P Industries Inc. and the Triad Group of Hartland, Wis., the FDA should have followed two worrisome inspections and the regulatory session with a formal warning letter, an enforcement action that requires prompt and thorough response, said Jeanne Ireland, the FDA's assistant commissioner for legislation.

Such a letter would have served to "reinforce FDA concerns about GMP [good manufacturing practice] deviations," Ireland said in a letter sent late Thursday to Sen. Michael Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn. The letter followed an "internal retrospective review" of the agency's oversight of the company, she wrote.

Instead, the Wisconsin firms, which are owned and operated by the same family, were allowed to pursue voluntary improvements in safety and sterilization procedures. As a result, the company continued to make and ship the potentially tainted products, records show.

The two senators had demanded explanations from the FDA earlier this year after residents of their states alleged they were sickened by bacterial contamination from alcohol prep wipes, swabs and other products recalled by the Wisconsin firm.

“The incidents relating to Triad wipes, as well as the recent recalls of children’s medicine and deaths associated with heparin , remind us all too clearly that the supply chain for drugs and medical devices needs to be fixed," said Bennet. "The last thing families in Colorado and across the country should have to worry about is that the treatments they use may do them harm, or potentially worse."

Bennet and Alexander's attention followed a series of msnbc.com articles that reported that as early as July 2009 the FDA knew of problems with contamination and shoddy sterilization at the plants that made and distributed medical supplies and drugs widely used in hospitals, clinics and home care and sold by the nation's top drug and grocery store chains, including Walmart, Safeway, CVS and others.

In April, the FDA asked the U.S. Marshals to seize more than $6 million worth of H&P Industries Inc. products to prevent the firm from distributing products that may have been tainted with two dangerous bacteria, Bacillus cereus and Elizabethkingia meningoseptica, which can cause deadly infections.

Shortly before that, the FDA had asked the company to voluntarily cease all production and distribution. The firm halted operations on April 18, the FDA reported.

The moves follow massive recalls starting in January of all lots of alcohol prep products and, later, povidone iodine products because of potential contamination. The firm also recalled lubricating jelly commonly used in medical exams and procedures because samples were tainted
Source:msn.com