Pitchrate | FDA seizes control of three J&J factories

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03/25/2011 02:49pm
FDA seizes control of three J&J factories

FDA seizes control of three J&J factories

By Tabish Talib

After a recall of multiple drugs in recent past, like Children’s Tylenol, the federal government takes over three Johnson & Johnson plants.

In response to the long list of Johnson & Johnson recalls this past year, which includes Tylenol, the Food and Drug Administration (FDA) took control of three J&J production plants.

The J&J plants, located in Las Piedras, Puerto Rico, Lancaster, Pa., and Fort Washington, Pa., were connected to the recall of multiple drugs in 2010 and to the Children's Tylenol three months ago, according to a McNeil Consumer Healthcare press release.

The FDA took control of the plants through the "consent decree" of McNeil Consumer Healthcare in order to bring the plants up to manufacturing standards.

The plants in Las Piedras and Lancaster will continue to operate, while the Fort Washington plant will be closed, McNeil Consumer Healthcare spokeswoman Bonnie Jacobs said to CNN Money.

"There is the potential for some impact [in production] initially as we implement the additional steps," Jacobs told CNN Money.

Jacobs declined to comment on the subject.

The two functioning plants will work with an independent expert who will present a report to the FDA about the manufacturing standards of the plants, after which the FDA will decide on how to move forward, according to a McNeil Consumer Healthcare press release.

J&J is trying to address all concerns of its consumers, said J&J Vice President of Corporate Media Relations Bill Price.

"We're moving ahead with organizational changes as well as the manufacturing changes at the McNeil plants," he said.

Price added that J&J CEO William Weldon,addressed concerns over the company's management team which some believe are responsible for the recalls.

"Clearly the McNeil Healthcare recalls have been a major issue and working with the FDA we can get products back on the shelves," he said.

Michael Santoro, professor of management and global business at the Rutgers Business School, believes the blame on the vast amount of recalls lies in how the problem was handled at the corporate level.

"It took Johnson & Johnson a long time to address the problems with the recalls. That is why the FDA is involved," he said. "It's clearly a management problem especially with the CEO and J&J's Board of Directors."

Santoro believes these past recalls have been handled poorly compared to how they were handled in the past. The Tylenol recall in the 1980s was handled cleaner by then CEO James Burke, he said.

"The way that situation was handled is why J&J continues to have good reputation," he said.

He added that J&J also has more of a reason to care about their public image than most other pharmaceutical companies because of the line of products they sell.

"Johnson & Johnson is distinctively diversified more than other companies," Santoro said. "They sell baby shampoo and baby medication, which is why if a recall is handled poorly it could hurt the public's opinion of the company."

Other problems, such as the loss of business due to recalls, have lasting effects, said Maaz Enver, an Ernest Mario School of Pharmacy graduate student.

"You can't forget that there is nearly always a generic drug with the same active ingredient as the name brands," he said. "People have this idea of a name brand drug to be better."

But the danger for drug companies is that generic versions of drugs are cheaper than the name brands, Enver said.

"If your product is off the shelf, it's easier for people to try the generic version and never buy the name brand again because the generic worked for them just as well," he said.

Another incentive for J&J to allow a consent decree at the McNeil Consumer Healthcare plants are the reprimands they could have faced otherwise, Santoro said.

"This is a terrible blow to J&J and it shows that by allowing to be supervised by a third party, there could have been major action and penalties forthcoming from the FDA," he said.


drug recalls, fda, johnson johnson, pharmaceuticals
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