FDA docs: J&J knew of problems with Motrin in 2008
WASHINGTON - May 27, 2010 -- Johnson & Johnson learned of potential problems with its Motrin formula in 2008, but instead of issuing a recall, hired an outside contractor which began buying up the products, according to congressional investigators.
Colleen Goggins, J&J's president for McNeil consumer products, will testify before House lawmakers Thursday about ongoing quality problems with its over-the-counter medications.
Last month McNeil recalled more than 40 varieties of children's medicines after Food and Drug Administration inspectors discovered a slew of violations at a company plant.
Some of the medicines recalled contained tiny particles of metal, though federal health regulators say the risk of health risks is remote.
The recall is the latest in a series that threaten to tarnish J&J brands like Tylenol and Benadryl.
Lawmakers will question Goggins about the latest problems as well as its handling of a 2009 recall.
According to FDA documents cited by congressional investigators, J&J learned of problems with some of its Motrin tablets in November 2008.
The company hired an outside contractor to collect samples of the product and determine whether a recall was necessary. The key question was whether the tablets dissolved properly to deliver an appropriate dose of the pain-relieving ingredient ibuprofen.
Ibuprofen is a pain reliever and fever reducer similar to Tylenol's main ingredient acetaminophen, though it can sometimes cause upset stomach.
But instead of testing the product, FDA found that the contractor purchased lots of Motrin from retailers and instructed employees "not to mention a recall."
"I don't think we fully understood what was going on, but it was troubling to us," said Dr. Joshua Sharfstein, FDA's Deputy Commissioner, adding that the incident "reflected poorly on the company."
J&J recalled the lots of Motrin in July 2009, when FDA inspectors confronted the company about the contractor's activities.
"This 'phantom recall' warrants further investigation by this committee," said Rep. Edolphus Towns, D-N.Y., in his opening statement Thursday. "Who at McNeil and Johnson & Johnson knew about this scheme? How high up in the corporate suite was this scheme hatched?"
Towns chairs the House Committee on Oversight and Government Reform.
In testimony Thursday, Sharfstein laid out J&J's repeated violations of quality and manufacturing procedures, which have resulted in three recalls in the last eight months.
FDA held a meeting with J&J executives in February urging them to overhaul their manufacturing operations.
"FDA told the company's leadership that significant, immediate steps were needed to address issues of compliance and quality," said Sharfstein.
Since the April 30 recall, the FDA has received hundreds of reports of complications with J&J products, including seven deaths, according to a memo distributed to congressional staffers.
The FDA has not directly linked any medical problem to the recalled J&J products.
johnson & johnson, recall, local/state
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