House lawmakers rip into FDA, Johnson & Johnson for 'misleading' Congress, public on Motrin recall

Top House lawmakers on Thursday accused government regulators and a major drug company of misleading Congress and the public over last year's recall of a defective pain medication.

Johnson & Johnson executives should have told the public it was pulling defective Motrin off the shelves, the lawmakers charged, while the Food and Drug Administration (FDA) should have pushed harder for the company to do so. Both groups misled Congress about their involvement in the episode, some members alleged.

But while Democrats tended to focus their criticisms on company executives for putting shareholders above public health, Republicans spent more time blasting federal regulators for not going further to protect consumers. 

"The pattern emerging at FDA is one of carelessness, deficiency, and untruthfulness," said Rep. Darrell Issa (Calif.), senior Republican on the House Oversight and Government Reform Committee. "Johnson & Johnson and its subsidiaries do not get a pass," he added, "[but] the government has failed to do its job." 

Rep. Edolphus Towns (D-N.Y.), chairman of the panel, didn't disagree, but argued the primary responsibility in drug safety cases rests with the company. 

"Even if the FDA was technically aware of it, that does not excuse what Johnson & Johnson did," Towns said. "[The company] had both the legal and moral obligation to do the right thing, and they did not."

The controversy swirls around the 2009 voluntary recall of defective Motrin tablets. To prevent the public from learning of the event, a J&J subsidiary (McNeil) hired third-party contractors to buy up defective pills from retailer shelves, rather than launching a national recall, which would have alerted the media.

Not even the retailers stocking the defective pills were told of the plan.

"Run in, find the product, make your purchase and run out," the contractors were instructed. "There must be no mention of this being a recall of the product."

The tablets weren't suspected of posing a health risk, but they contained lesser amounts of active medicine — and were therefore less effective — than the label advertised. 

As part of the committee's investigation, lawmakers learned that J&J officials told the FDA about the defect as early as November 2008, but agency officials didn't press the company for a national recall until seven months later. In the meantime, J&J informed the agency that its contractors were visiting drug stores to "assess" the situation, but failed to mention that the contractors were buying up the medication.

The company, FDA's Principal Deputy Commissioner Joshua Sharfstein testified Thursday, "did not disclose the phantom part of the phantom recall."

Appearing before the oversight panel, J&J executives at turns apologized for and pushed back against the charges that they didn't tell the FDA what they were up to. 

"We should have notified them that we would be taking these products … off the shelves," J&J CEO William Sheldon said. "You're absolutely correct that we made a mistake. But we feel we did keep people informed as to the actions we were taking."

It wasn't the only apparent discrepancy. Weldon also said he was ready to accept "full accountability" on behalf of the company, but  later added that he "can't comment for the conversations that go on across the organization."

Meanwhile, Colleen Goggins, head of J&J's consumer group, reiterated her statement — made before the panel in May — that she knew nothing of the recall at the time.

"I did not know that at the time of my testimony — I don't believe," Goggins said.

Much of Thursday's hearing, though, highlighted the different philosophies of the two parties as it pertains to government oversight. Issa maintained that the focus of the panel should be the conduct of federal agencies. 

As the committee's name suggests, Issa said, "we are overseeing government."

The remark wasn't overlooked by some Democrats, who argued that the panel's responsibility is broader than that. 

"This committee is not just oversight of the government," said Rep. Dennis Kucinich (D-Ohio). "It's [also] oversight of misconduct in the private sector."

Towns was quick to note that the FDA lacks the authority to force a company to recall a product, regardless of the threat to public health. 

"Even if the FDA had been notified about the Motrin problem, the agency did not have the legal authority to order a recall," Towns said. "This needs to be rectified." 

The debate carries echoes of other battles swirling around Capitol Hill in recent months. In the wake of deadly accidents in a West Virginia mine and on a Gulf of Mexico oil platform, for instance, Democrats have called to expand the powers of the federal regulators overseeing those industries. Republicans, though, have rejected the proposals, arguing they would force expensive new requirements on private companies, crippling their ability to hire amid an employment crisis.

Some Democrats on Thursday noticed a discrepancy between the Republicans' criticism of government regulators and their opposition to bills lending the same agencies stronger teeth. 

"On one hand, some of my colleagues would reject a beneficial role for government in people's lives," Kucinich said. "And on the other hand, when a regulatory agency does attempt to assert government responsibility for corporate misconduct, that's not recognized."

But Issa maintained that granting the agency greater power is no indication it would use it. 

"Even if we gave them additional authority for mandatory recalls, if they were complicit in a silent recall, then to what end would that new authority be?" he asked.