Congress has many questions for drug manufacturers

Posted on May 27, 2010

After the recall of Children's Tylenol and other Johnson & Johnson children's products, many consumers turned to generic brands of over-the-counter medications at the recommendation of the Food and Drug Administration. The drugs recalled last month may have contained metal particles, or too much of the active or inactive ingredients than meets federal standards.

However, it seems that consumers may have more to worry about than just the brand-name drugs. Perrigo, a Michigan-based company that manufactures the generic equivalent of many children's drugs for CVS, Walgreens and other similar pharmacy chain stores has just received a warning letter from the FDA for manufacturing violations of its own, including the possibility of metal shavings in its products.

This comes as Thursday, the day of the Congressional hearing regarding the circumstances of the Johnson & Johnson recall, draws closer. The House Committee on Oversight and Government Reform has invited both the drug company and the FDA to testify. Congress wants to look into the chronology and cause of the manufacturing issues surrounding the recall and whether or not federal regulators responded adequately.

Meanwhile, Perrigo says it is working with the FDA to correct problems. The FDA has cited quality-control issues at the Perrigo plant, just as it did for Johnson & Johnson. According to their inspection report, the FDA claims the problems at the McNeil factory in Fort Washington, where Johnson & Johnson manufactures its products stemmed from multiple violations. These issues consisted of a failure to investigate and take corrective action following consumer complaints, unclean equipment, failure to train employees in good manufacturing patterns and possible bacterial contamination.

With the similarities that are arising at the Perrigo plant, the House Committee is concerned that this is symptomatic of a patten of quality-control lapses in American pharmaceutical companies and questions the FDA's actions. The FDA still stands by their recommendation to consumers to switch to generic alternatives. However, the question still remains for Congressional representatives, why is there a lack of control in the United States and will there be more cases in the future?
























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