Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The Mysterious World of "Mechanism of Action" Explained

The Mysterious World of "Mechanism of Action" Explained | Pharmaguy's Insights Into Drug Industry News |

How confident are you that the drugs you take, whether they’re over-the-counter or prescription, are totally understood by the companies who make them? Drug makers know what their products do when they enter your body, right?

You shouldn’t assume that.

Even drugs like acetaminophen have a mostly secret life once they’re inside of us. That has to do with our mysteriously complex biology and something called the “mechanism of action.”

In this episode of Signal, we talk everything from Tylenol to fen-phen to Viagra and why you should probably think hard before you take any drug at all.

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J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability

J&J Pleads Guilty for Knowingly Selling Tainted Children's Tylenol. A Failure of Corporate Accountability | Pharmaguy's Insights Into Drug Industry News |

The maker of Children’s Tylenol agreed to plead guilty to a federal criminal charge of knowingly selling adulterated bottles of its painkillers for children and infants. The drugs were recalled in 2010 because they contained metal particles.

Prosecutors accused the company of continuing to sell the tainted products for nearly a year after discovering the problem, also claiming that McNeil failed to take immediate steps to fix the cause of the adulteration.

The Johnson & Johnson subsidiary first learned of the particle problem in May 2009, when a consumer complained about black specks inside a bottle of Infants' Tylenol, according to court documents.

McNeil subsequently found metal particles during production but continued making the liquid medicines for several more months. The company and prosecutors said Tuesday that no one was injured due to the tainted drugs.

However, Shawn Arndt, whose 4-year-old son Joshua died after taking one dose of Infant’s Tylenol, sued the company in 2012. The US District Court for Eastern Pennsylvania dismissed his suit in December 2014, in part because Joshua died in November 2009, several months after the recall went into effect.

Pharma Guy's insight:

The New York Times reports that "Johnson & Johnson appeared to abandon its own template [ie, the gold standard in brand crisis management], stunning a few business school professors. Its conduct also drew harsh criticism from federal officials" (see "In Recall, a Role Model Stumbles").

At issue was the slow response to reports of contamination of popular over-the-counter medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol.

In a letter to Peter Luther, President, NA OTC, McNeil Consumer Healthcare (see end of this post), FDA said "We are aware of the complaint information available to your company, the sequence of events, and the extent of your firm's follow up measures during this period. We have concluded that your company did not conduct a timely, comprehensive investigation."

The New York Times took J&J to task for not covering this in its coporate blog: "Johnson & Johnson’s conduct is all the more out of step, analysts said, because the drug maker had been one of the first in the pharmaceutical industry to set up its own blog, of Sunday at 6 p.m., on the issue of the current recall, the blog so far has had no comment from the company."

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