The other day I wrote a story about the massive recall by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, of its infants' and children's line of Tylenol products. An FDA inspection report found these drugs to be contaminated with dangerous bacteria (they did not disclose the actual type) as well as "foreign materials" that were visible as "dark or black specks". But a recent story published by USA Today has revealed that McNeil actually knew about the bacterial contamination and kept shipping the products anyway.
Only the drug industry could get away with this type of careless, reckless behavior with nothing more than a slap on the wrist from the FDA. In fact, the FDA did not even require McNeil to issue a recall after discovering the problem; McNeil did so voluntarily over "theoretical concerns" that were expressed by Deborah Autor, an FDA official who was quick to emphasize that the risk to consumers from the tainted products "is remote".
So let me get this straight. An FDA report finds that a pharmaceutical company is knowingly using contaminated raw materials to make children's and infants' medicines in a factory that is failing to maintain its equipment, properly train its employees and correctly measure and weigh drug ingredients, and FDA officials consider the problem to be "theoretical"?
Can you imagine what would happen if an herbal product manufacturer were found to engage in the same behavior? The FDA would pounce on them, seize their products, issue a public warning and probably fine the company for its reckless behavior. But when Big Pharma pulls the same stunt, it's just business as usual.
To the FDA, it's all just "theoretical"
My favorite part about this is the FDA's reliance on the word "theoretical" to try to imagine that somehow no actual safety problem existed. According to my thesaurus, some other words for theoretical include unsubstantiated and hypothetical. In other words, the FDA is saying it does not actually believe that a real risk even exists!
And yet FDA Commissioner Margaret Hamburg, at the same time as the agency is saying there really is no risk and that the whole thing is just a hypothetical situation, advises parents to "discontinue using any of the name-brand products being recalled."
Overdosing on acetaminophen, especially in children, is a serious issue. The Mayo Clinic website warns parents that overdosing on the drug, even a little bit, can lead to "life-threatening liver problems."
The FDA report specifies that McNeil's had not been properly formulating the drug dosages in its children's and infants' medicines, which is part of the reason for the recall. Improper concentrations of active ingredients in these products potentially puts millions of children at risk. But apparently this is no big deal to the FDA which sees it as nothing more than a "hypothetical" problem.
Yet, just prior to its expression of "theoretical" concern in the current recall, FDA officials met with McNeil back in February to express "serious concerns" about the company's poor manufacturing processes and failures to follow good manufacturing practices. So which is it?
This kind of double-speak is typical of the FDA when a case involves a beloved drug company. If this had been a supplement that was "hypothetically" thought to be contaminated (even if conclusive evidence revealed there was no threat at all), health food stores everywhere would be ordered to strip it from their shelves. But when drug company negligence leads to the contamination of children's medicines with bacteria, unknown particles and improper drug dosage levels, the FDA leaves it to the company to "voluntarily" recall their own products. There will probably be no fine levied against the company, either.
The FDA may not even hold McNeil responsible for its gross negligence
According to a recent Los Angeles Times article, the FDA has not even decided what corrective action it is going to take. According to the story, "options range from sending a warning letter to seeking criminal penalties."
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