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Taran March @ Quality Digest

FDA Compliance

Snake Oil, Anyone?

Johnson & Johnson’s over-the-counter medications promise quality, deliver lawsuits

Published: Thursday, December 9, 2010 - 08:40

Pharmaceutical manufacturer Johnson & Johnson, which for decades has enjoyed a trusted reputation for soothing babies and overcoming head colds, is currently facing criminal investigation by the U.S. Food and Drug Administration (FDA). The company’s McNeil Consumer Healthcare unit closed a facility in Fort Washington, Pennsylvania, this summer after the FDA cited multiple manufacturing violations there. Millions of Tylenol, Motrin, and Benadryl formulas have been recalled, and Johnson & Johnson CEO William Weldon has faced two congressional hearings about it. Where, in all this mayhem, are the company’s quality control people? Have they succumbed from sampling too many defective products?

It’s tempting to get clever at J&J’s expense, and many articles and blogs have given in to the urge. “Just when you think it’s safe to return to the drugstore,” “J&J heartburn worsens as Mylanta joins recall list,” and “Make them do the perp walk!” are a small sampling. But for anyone in the quality industry, smiles can quickly become strained. Such blatant oversights on the part of a high-profile company in a high-trust industry are, well, sickening.

We’re not talking about just an isolated incident, a single juicy bone over-gnawed by media hounds. When a CEO heading a company of 118,700 employees apologizes before the House Government Oversight Committee (“We did not maintain our high quality standards,” Weldon understated), and the FDA goes well beyond its dreaded Form 483 for “inspectional observations” and refers the matter to its office of criminal investigations, we’re talking bona fide, no-positive-spin malfeasance. Johnson & Johnson has let the quality community down, too.

In November 2009, the first in an accelerating list of product recalls began after consumers reported a musty, moldy odor emanating from their freshly opened bottles of Tylenol. Some people suffered a brief and uninvited bout of vomiting, nausea, and diarrhea after taking the pills. The problem was traced to McNeil’s Las Piedras, Puerto Rico, plant, where a chemical coating the pallets on which the product was stored had broken down and leaked into the bottles.

In January of this year, the FDA issued a warning letter to McNeil’s CEO Peter Luther telling him to clean up the corporate act down there. The company recalled Tylenol, Motrin, Rolaids, St. Joseph aspirin, and Benadryl allergy tablets, all carrying the by-now-infamous odor.

In April, millions of doses of children’s Motrin, Tylenol, Zyrtec, and Benadryl manufactured at McNeil’s Fort Washington, Pennsylvania, plant were recalled after FDA investigators found bacterial contamination, lax quality testing, and inadequate worker training there. This was the largest recall of children’s medications in the history of federal oversight, according to the FDA, and resulted in notably bare shelves in drugstores this summer, sparsely filled in with generic substitutes.

The Pennsylvania plant has been closed indefinitely, with 300 of its 400 employees sent packing while the place is refitted and reorganized. (“Staffing levels at the reconfigured plant are expected to be substantially lower than they are today,” McNeil anticipated in July.)

Meanwhile, parent company Johnson & Johnson had some explaining to do to various federal officials. During a May 27 hearing, the FDA accused J&J of paying a contractor to buy up tainted medication rather than announcing a recall. In June, the chairman of the investigating congressional panel found the company stubbornly unwilling to provide requested information.

By July, the moldy smell had spread to Benadryl Allergy Ultratabs, Children’s Tylenol Meltaway Strips in Bubblegum flavor, varieties of Tylenol Extra Strength tablets, and Tylenol PM. More recalls followed.

Even assuming these very public events meant that McNeil was complying with FDA demands but was simply caught in the media meat-grinder, there’s still the question why it took the company nearly eight months to quarantine bad product and establish a corrective action process at one plant.

But last month, any impulse to cut McNeil and J&J some slack disappeared in an avalanche of yet more recalls: Junior Strength Motrin Caplets, Children’s Benadryl Allergy Fastmelt Tablets, Rolaids—you can read the complete list of recalls here. There are 12 product brands in all, half of them for children. These have been followed, in short order, by Tylenol Cold Multi-Symptom liquids, Mylanta, AlternaGel antacid, and Acuvue Trueye one-day contact lenses.

All told, more than 200 million bottles of J&J products have been recalled this year.

Late last month the FDA filed another Form 483 on the Puerto Rico plant, a 10-page indictment clearly showing that neither McNeil nor J&J had managed to address basic quality issues. Among the report’s findings were distribution of drugs that failed quality requirements, failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls, and inadequate training of lab staff.

Pretty sad, huh? This from a company founded in 1879 by Robert McNeil, who purchased a Philadelphia drugstore for $169 to use as a retail pharmacy. McNeil’s son helped establish McNeil Laboratories in 1933—the start of the Fort Washington facility that was closed this year—where early versions of acetaminophen were created. Johnson & Johnson bought the company in 1959. All the elements of can-do, feel-good American enterprise were scrupulously built in; all, in the space of a year, negligently stripped away.

And what about Johnson & Johnson, presumably McNeil’s guiding hand? Unlike Toyota, which also weathered expensive recalls and loss of face this year, J&J seems to have distanced itself from the McNeil epicenter. Where Toyota made a point of broadcasting its response to its own series of recalls (see this  Quality Digest Daily article as an example), Johnson & Johnson has said nothing. At its news page, a single sentence in small type tersely directs consumers to McNeil’s recall page, www.mcneilproductrecall.com.

By contrast, when Toyota had its massive recall, it did not create a web page called “CTSacceleratorpedalrecall.com” (CTS is the company that actually manufactured the accelerator pedal systems used in the recalled Toyotas). Toyota’s recall site? www.toyota.com/recall. That’s what owning up to your mistakes is about. It’s called corporate accountability.

Johnson & Johnson is barely paying lip service to what quality assurance really means. Until it does better, its promises have about as much value as snake oil hawked at a medicine show.


About The Author

Taran March @ Quality Digest’s picture

Taran March @ Quality Digest

Taran March is Quality Digest’s editorial director. A 35-year veteran of publishing, she has written and edited for newspapers, magazines, book publishers, and universities. When not plotting the course of QD with the team, she can usually be found clicking around the internet in search of news and clues to the human condition.


Well, I'll be

Thanks, Michael. I didn't know that about snake oil. I was referring to the Wild West formula that had no curative properties.

Snake Oil Efficacy?

This is a sad note for a once great company.

Please note there really is a legitimate "Snake Oil." Although, not well know in the United States, there is an oil from the Chinese water snake, high in EPA (eicosapentaenoic acid) that relieves arthritis and joint pain. Snake oil is still sold in traditional Chinese pharmacy stores (http://en.wikipedia.org/wiki/Snake_oil).