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FDA Tried to Cover Up Children’s Motrin Recall With Johnson & Johnson?

October 1, 2010

The U.S. Food and Drug Administrators claim they didn’t know that Johnson & Johnson had started to “recall” children’s Motrin by asking private contractors to pose as consumers and try to buy up all the defective Motrin tablets on store shelves.  Senators have pressed the FDA to find out why they didn’t know about what is now being called Johnson & Johnson’s “phantom” recall scheme:

Johnson & Johnson executives and the Food and Drug Administration both shouldered the blame Thursday for a secret recall in which hired contractors quietly bought up defective painkillers to clear them from store shelves.

J&J Chief Executive William Weldon told House lawmakers the company “made a mistake” in conducting the so-called “phantom recall,” which is one of a string of problems that have drawn congressional scrutiny

In the same committee hearing, the FDA’s deputy commissioner, Dr. Joshua Sharfstein, said his agency should have acted sooner to halt J&J’s plan. At the same time, though, he stressed that regulators were not aware of the deceptive nature of the recall.

Sharfstein and Weldon testified before the House Committee on Oversight and Government Reform, which held its second hearing on J&J’s unprecedented spate of recalls. The largest, involving more than 135 million bottles of infants’ andchildren’s Tylenol and other medicines, triggered the committee’s investigation.

“We recognize that we need to do better, and we will work hard to restore the public’s trust and faith in Johnson & Johnson,” Weldon told lawmakers.

Democrats and Republicans pressed Weldon on its “phantom” recall involving 88,000 packets of Motrin, which Weldon acknowledged as “not one of our finer moments.”

But lawmakers also pressed the FDA on when and what it knew about the activity. New Brunswick, N.J.-based J&J has repeatedly claimed it alerted the agency’s officials in Puerto Rico, where the defective Motrin was originally manufactured.

Sharfstein said J&J informed the FDA of its plan to repurchase the pills – which did not dissolve correctly – in April 2009.

(By the way, the J & J issues with editing occur as a result of  Yahoo’s editing, not mine….)   Even though lawmakers are pushing the FDA, FDA spokesman says the fault really lies with Johnson and Johnson for producing bad medicine:

Republican lawmakers criticized a “too cozy” relationship between FDA and J&J employees, citing months-long e-mail exchanges between the two before regulators took action. But Sharfstein said ultimate blame lies with J&J, pointing out that the FDA does not have the authority to order when and how companies conduct recalls.

“I think fundamentally the responsibility is with the company to handle their quality problems in a much different way,” Sharfstein said.

Companies are advised to work with the FDA on recalls, although that isn’t a legal requirement.

Committee Chairman Edolphus Towns, D-N.Y., has introduced a bill that would give the agency the power to order recalls.

The maker of trusted brands like Tylenol and Benadryl, J&J has announced nine recalls of drugs for children and adults since last September with problems ranging from too much active ingredient to tiny shards of metal.

So, no faith in the FDA and Johnson and Johnson?  Well, Johnson & Johnson says that it’s investing money into upgrading its facilities.  And, well the FDA claims it is never at fault.  Little comfort to parents like us.

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