In addition to a record number of legitimate recalls, pharmaceutical giant, <"http://www.yourlawyer.com/topics/overview/Childrens-Tylenol">Johnson & Johnson was also involved in a secret, so-called â€œphantomâ€ recall in which a contractor was hired to purchase back potentially defective Motrin tablets. The secret buyback was implemented to avert a recall.
Now, Reuters reports that the U.S. Food and Drug Administrationâ€™s (FDA) chief condemned Johnson & Johnson for the move, saying that it was a far cry from how the drug maker had conducted business in the past. In the recent year alone, said Reuters, Johnson & Johnson has recalledâ€”publiclyâ€”nearly 200 million bottles of Motrin, Tylenol, and other products, such as childrenâ€™s medications, all over issues with quality control that the agency revealed at the drug makers factories.
Only recently did Johnson & Johnson acknowledge its part in the secret recall that took place in 2009, when potential defects were found, said Reuters. Contractors were hired to purchase the potentially defective Motrin 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 added, quoted Reuters. “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.”
We previously wrote that, while no formal agreement had been made with the FDA, the agency knew that Johnson & Johnsonâ€™s McNeil unit implemented the buyback program, according to its lawyers. Johnson & Johnson and McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, sent contractors nationwide to 5,000 locations to buy the defective drugs without the publicâ€™s knowledge.
We also previously reported that the FDA claimed no knowledge of the plans, although McNeil claims it apprised the agency saying, â€œMcNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner,â€ quoted ABC News previously. The agency told ABC news, â€œWhen the FDA learned that McNeil had hired contractors to secretly purchase product off the shelves, the agency advised McNeil to do a full recall, which the company agreed to initiate in July 2009.â€
Hamburg just stated that, “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 announcementâ€”in the effort to educate individuals and families so they can make appropriate choices and act accordingly with evolving information about potential risk,” quoted Reuters.
When asked if the agency warned drugmakers to avoid phantom recalls, 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,” reported Reuters.
The majority of recalled medications were manufactured at a Pennsylvania factory shut down in April by McNeil Consumer Healthcare over quality control issues, said Reuters. The FDA report indicated â€œthick dust, grime, and contaminated ingredients,â€ at the plant, which is not expected to reopen until late 2011, noted Reuters.