FDA chief criticizes J&J secret Motrin recall
The U.S. Food and Drug Administration’s chief criticized Johnson & Johnson’s secret recall last year of its Motrin painkiller, saying it was a departure from the company’s history of responsible behavior when it comes to public health.
Photograph by: Internet, Times Colonist
The U.S. Food and Drug Administration’s chief criticized Johnson & Johnson’s secret recall last year of its Motrin painkiller, saying it was a departure from the company’s history of responsible behavior when it comes to public health.
The diversified healthcare company in the past year has publicly recalled almost 200 million bottles of Motrin, Tylenol and other consumer brands, including dozens of children’s medicines, because of quality control lapses discovered by the FDA at its factories.
J&J recently acknowledged that it earlier also conducted a secret recall in 2009 of Motrin when possible product defects were identified, hiring private contractors to discreetly buy up the products from convenience stores and gas stations.
“Many people have noted that way back when, J&J was a model for responding to public health concerns and providing information to the public in a timely and open way, and their behavior of late has been somewhat different,” FDA Commissioner Margaret Hamburg said at the Reuters Health Summit.
“That is not a practice that I think supports optimal public health,” Hamburg said. “I was surprised when I first learned that that had occurred. When there’s concern about a product, the public deserves to know, so that they can make choices whether to use that product.”
“And if the product is coming off the shelves because of a concern about quality, certainly if it’s coming off with a significant concern about safety, there has to be a public announcement — in the effort to educate individuals and families so they can make appropriate choices and act accordingly with evolving information about potential risk.”
J&J had no immediate comment.
The company is facing a U.S. congressional probe of the repeated recalls of Tylenol, Motrin and allergy treatment Benadryl, including the so-called “phantom” Motrin recall which J&J failed to disclose to the public.
Asked if the FDA has warned drugmakers to avoid secret recalls in the future, Hamburg said, “My guess is that companies that have been watching recent events realize that this is not a practice that they should be engaging in.”
Most of the recalled consumer medicines were made at a factory in Fort Washington, Pennsylvania, which was shut down in April by J&J’s McNeil Consumer Healthcare unit to correct quality control lapses discovered there by U.S. regulators.
The FDA cited thick dust, grime and contaminated ingredients at the facility. J&J has said it does not plan to reopen the plant until late next year. Meanwhile, it is using other McNeil plants to help offset lost production of the recalled products.
No injuries from recalled products have been reported, but many consumers are turning to cheaper, store-brand alternatives.
Reuters
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