Members of a Congressional Committee today questioned whether some of the problems that resulted in several recalls of over-the-counter medicines at drug maker Johnson & Johnson were symptoms of a "too cozy" relationship between the company and the Food and Drug Administration.
Meanwhile William C. Weldon, the company's chairman and CEO, offered the panel profuse apologies for problems that led to the recall of 135 millions bottles of children's liquid medicines and smaller amounts of Motrin pills.
"This was not one of our best moments. ... We did not maintain our high quality standards and as a result children did not have access to our important medicines" Weldon told the House Oversight and Government Reform Committee. "We let the public down."
"We have learned a lot of lessons from this unfortunate situation. I can only assure you that we will do everything in our power to never let this happen ever again."
Weldon's comments came as the company's McNeil Consumer Healthcare subsidiary readies to start returning its children's liquid medications to store shelves next week and the Justice Department conducts a criminal probe of actions by the company and by FDA officials.
The return of the products comes amidst continuing FDA concerns about the company's manufacturing procedures.
Dr. Joshua M. Sharfstein, FDA principal deputy commissioner told the committee today that after looking at the company's Pennsylvania plant that made the liquid children's medicines, the FDA took a closer look at the company's other plants.
"The company had an inadequate quality system that you could see in multiple facilities," Sharfstein told the committee. He said the FDA is closely watching the company's actions.
While the March recall of children's medications was the big recall, much of the committee's focus today was on a smaller earlier recall of Motrin 8 packages sold mostly in gas stations and convenience stores that took place in 2009, six months after the FDA was first told of problems.
Johnson & Johnson in 2008 learned the tablets hadn't been made right and didn't dissolve correctly and told the FDA. Instead of conducting an immediate recall of an ineffective medicine, the company first wrongly told the FDA the products was largely off store shelves while knowing otherwise, then six months later sent contractors out to buy any remaining quantities, even then keeping secret the product was being recalled. Congressmen called the result a "phantom recall." Company e-mails bragged that the move avoided bad press and was done because of a close relationship with the FDA.
Sharfstein accused the company of deceiving the FDA, but Congressmen questioned the actions of both the FDA and the company.
"It looks like there was much too much of a cozy relationship," said Rep. Jason Chaffetz, R-Utah.
Committee Chairman Eldolpus Towns, D-N.Y., pointed to the company.
"Even if the FDA was technically aware of it, that does not excuse what Johnson & Johnson did," he said. "Johnson & Johnson had both the legal and moral obligation to do the right thing, and they did not."
He also noted Weldon's statement that the company works cooperatively with the FDA.
"There is often only a thin line between 'working cooperatively" and having a "cozy relationship,'" he said. He accused the company of "trying to pull a fast one" on the American people.
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