FDA, Johnson & Johnson Face Criticism Over Drug Recalls

The Food & Drug Administration (FDA) faced criticism yesterday from members of the House Committee on Oversight and Government Reform for having a relationship with drug maker Johnson & Johnson that some said may have been “too cozy.” Several on the committee asserted that this relationship made it difficult for the FDA to enforce its rules.

Yesterday’s hearing was the second the Oversight Committee has called to investigate a string of recalls by Johnson & Johnson’s McNeil Consumer Healthcare Unit. Over the past year, the company has issued a total of six <"http://www.yourlawyer.com/topics/overview/Childrens-Tylenol">drug recalls that involved 200 million bottles of medicine. The largest occurred in April, and involved 40 varieties of children’s Tylenol and other medicines. McNeil has since shut the Fort Washington, PA facility that made some of the recalled drugs to address manufacturing problems cited by an FDA inspection. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

The committee was also looking into what some have characterized as a “phantom recall” of Motrin tablets that occurred in 2009. At the time, the company hired a contractor to send out employees posing as buyers for an eight-caplet package sold at 4,000 convenience stores in 40 states. Contractors who participated in the program were told not to mention the term “recall.” Johnson & Johnson has asserted that the FDA knew of and approved of its actions, but the agency disputes that. McNeil finally recalled 88,000 packages of the drug in July 2009.

During yesterday’s hearing, some committee members raised questions about the number of times FDA inspectors had visited the Pennsylvania plant. “I’m trying to understand why the FDA was so slow in going ahead and making a decision. The FDA went back to that plant and back and back,” said Rep. Darrell Issa (R-Calif).

Joshua Sharfstein, the FDA’s principal deputy commissioner, acknowledged that the FDA had identified lapses at the plant. “If the FDA had the authority to recall, things would have gone much differently,” he said. Sharfstein also said the agency was now diligently monitoring McNeil’s progress to address problems at the Pennsylvania facility.

Sharfstein also said that the FDA should have done more in regards to the 2009 Motrin buyback, but he insisted that it had not known about Johnson & Johnson actions.

During the proceedings, Johnson & Johnson did not remain unscathed. “Johnson & Johnson does not get a pass. This will mar the company’s image for years to come,” Issa said.

Johnson & Johnson CEO Bill Weldon conceded in his testimony that “this was not one of our best moments,” but promised the company was committed to fixing its problems.

“I know that we let the public down,” he said. “We did not maintain our high-quality standards, and as a result, children do not have access to our important medicines.”

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