September 22, 2010 / 7:35 PM / 9 years ago

J&J to Congress: Motrin buyback was legal, FDA knew

WASHINGTON (Reuters) - U.S. health regulators knew that Johnson & Johnson’s McNeil unit was using a contractor to buy back potentially faulty batches of Motrin, although there was no formal agreement with the government, lawyers for the company told lawmakers.

Still, in a letter to the House Oversight and Government Reform Committee on Wednesday, J&J’s lawyers said although the purchases of defective painkiller directly from retailers were legal, “moving forward the company would handle things differently.”

The letter came ahead of a hearing next week over the diversified healthcare company’s widespread recall of more than 40 products, including the popular Children’s Tylenol, and the shutdown of one of its plants until at least next year.

As part of the committee’s investigation the company has also come under fire for a so-called “phantom recall,” in which J&J hired an outside company to purchase the faulty Motrin directly from retailers.

The U.S. Food and Drug Administration said that as soon as it learned of the problems, it called on McNeil to initiate a recall of the product.

But in their letter, obtained by Reuters on Wednesday, the company’s lawyers said McNeil kept “FDA apprised of its actions” even though there was no formal or written agreement over how to conduct the recall.

The company is “not aware of any indication” that the FDA disagreed with McNeil’s plan to hire a contractor to visit retailers, they added.

“We believe this record illustrates that McNeil acted with good intentions by keeping the FDA apprised of its actions and that there was no intent to conceal McNeil’s activities from the FDA,” the lawyers wrote in the September 22 letter.

The House committee is scheduled to meet September 30.

Reporting by Susan Heavey; Editing by Gerald E. McCormick

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