FDA should have authority to demand recalls for defective products, Democrats say

Democrats want stronger FDA voice on recalls

WASHINGTON — In spring 2009, a group of contract workers, going mostly to gas station convenience stores, bought up thousands of bottles of Motrin that had been determined to be defective but not dangerous. The workers had been hired for Johnson and Johnson, which wanted to remove the pills from the market without issuing a public recall.

J&J executives insist the Food and Drug Administration was aware of the purchasing program, but FDA officials deny that claim. In the end, though, FDA approval really wasn’t necessary: the agency does not have authority over when and how products should be recalled.

House Democrats want to change that. In a hearing Thursday, Oversight and Government Reform Chairman Edolphus Towns

will use the secret recall of Motrin and other recent public recalls by J&J to make the case that the FDA should be able to order companies to immediately call back defective products. The New York Democrat has introduced a bill that would give the agency that power.

The panel will hear from Johnson & Johnson’s chief executive officer, William Weldon, whose company has recalled millions of bottles of over-the-counter medicines in the past year, as well as the FDA’s deputy commissioner.

In testimony prepared for the hearing, Weldon suggested the company would not use the “phantom recall” method of removing products again.

“This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products,” Weldon said.

Currently, recalls are initiated by manufacturers, who alert the FDA to their plans. Companies are advised to work with the agency in planning how to conduct the recall, although this isn’t a legal requirement.

“If someone is making a product that’s shabby or dangerous I think the public perception is that the FDA comes in like a tiger and protects us,” said William Vaughan, health policy analyst with Consumers Union. “But the reality is that they knock on the door much softer than the public expects.”

For more than a year, the FDA’s Obama-appointed leaders have been working to bolster the agency’s regulatory image, following a string of food and drug safety scares under the previous administration.

However, the recent recall of more than a half-billion eggs linked to salmonella has underscored the limits of the agency’s powers. A food safety bill moving through the Senate this week would allow the agency to order food recalls.

The FDA is also weathering criticism from congressional Republicans, who this week asked federal inspectors to investigate the agency’s handling of J&J’s recalls.

Ranking Republican Rep. Darrell Issa of California sent a letter to the inspector general who oversees the FDA on Tuesday, asking him to investigate the agency’s role in the Motrin recall.

In particular, Issa complained that the FDA has refused to allow the committee to interview agency staff in Puerto Rico, who he says would have firsthand knowledge of the agency’s conduct.

Issa and other committee members will question FDA Deputy Commissioner Joshua Sharfstein, who is scheduled as the first witness at Thursday’s hearing. President Barack Obama appointed Sharfstein to his post last spring.