FDA Official: Johnson & Johnson's 'Secret' Recall No Secret

FDA official testifies agency knew about Johnson & Johnson's "phantom" recall.

ByABC News
September 20, 2010, 8:05 AM

Sept. 30, 2010 -- A U.S. Food and Drug Administration deputy commissioner testified before Congress today that the agency did not act quickly enough to stop Johnson & Johnson from carrying out a "phantom" recall last year.

Dr. Joshua Sharfstein divulged new details about when the FDA learned about Johnson & Johnson's plan to buy defective Motrin off store shelves instead of issuing a formal recall of the painkiller.

In documents obtained by ABC News Wednesday night, it appeared as if the FDA had known about Johnson & Johnson's plan to buy back faulty Motrin made in San Juan, Puerto Rico. E-mails revealed that the FDA's San Juan district director had forwarded field action reports from employees at McNeil, Johnson & Johnson's consumer health care unit, that mentioned the plan to buy back the product.

Previous FDA statements suggested the agency had not known about the company purchasing the defective Motrin until July.

The San Juan e-mails found their way to FDA headquarters in Washington. In a Feb. 18 e-mail chain, Milind Ganjawala, who works in the FDA's Recalls and Shortages Branch of the Office of Compliance, was asked to review the accuracy of a paragraph about the Motrin recall that contained the following passage: "Instead of notifying the agency and issuing a recall of the product, your firm hired a third-party company to buy back the Motrin from the pharmacies and retail locations." Ganjawala wrote back saying, "The firm did notify the FDA via FAR's [field reports]. ... According to the document we have, the silent recall was ongoing on or around 6/12/09."

E-Mails Show FDA in Puerto Rico Knew of Plan

Although FDA officials said they did not know about a "phantom" or "silent" recall, in e-mails obtained by ABC News senior employees of the McNeil subsidiary were congratulating one another on receiving FDA support for their plan to buy back their product in lieu of a formal recall.

"Good news," one e-mail began. The FDA director in San Juan "is in agreement with continuing to pull product from the rest of the stores and NOT consider this a National Recall." Another e-mail stated that the FDA "is really bending the rules" by not automatically urging a recall, while another e-mail called the buyback program "a major win for us as it limits the press that will be seen."

Johnson & Johnson declined ABC News' request for an interview. However, the company said in a statement that "McNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner. However, given the concerns highlighted by the congressional committee with respect to Motrin, moving forward we would like to handle things differently."

The e-mails also revealed that senior executives at Johnson & Johnson's McNeil subsidiary coordinated the $400,000 Motrin purchase program from the start. The e-mails read: "Do not communicate to store personnel any information about this product. Simply visit the store, locate the product and if any is found, purchase all of the product."

One e-mail showed McNeil President Peter Luther authorizing the program, saying: "Let's make this happen ASAP."

There have been eight other Johnson & Johnson recalls in the past year -- 136 million bottles of children's medicines, including Children's Tylenol, Motrin Infant Drops, Children's Benadryl and Zyrtec.

The Motrin saga began in November 2008, when Johnson & Johnson and subsidiary McNeil learned that some of its Motrin tablets were not dissolving properly, and the medication might not work as expected.

Usually when there's a manufacturing problem, the product is recalled even if it does not pose a danger to consumers, as was the case with Motrin.

Instead of a recall, contractors were sent to 5,000 convenience stores around the United States to quietly purchase the defective Motrin without alerting the public.

"I had been told not to say that this was a recall," said Lynn Walther who works for a Portland, Ore., inventory company. "I did not understand why I should be telling someone that this is not a recall when in my mind it was a recall."

In an exclusive interview with ABC News, Walther said that a contractor hired him to walk into convenience stores and quietly buy specific lots of Motrin IB caplet eight-count vials. Although he said his purchases were often met with puzzled looks from store owners, Walther said he had been told not to offer an explanation. Walther said he followed the instructions he'd been given.

"You should simply act like a regular customer while making these purchases," the document stated. "There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."