Drugmaker queried over Motrin recall
Johnson & Johnson says FDA knew of its actions
WASHINGTON – Congressional investigators said Wednesday that Johnson & Johnson hired a private company that bought up defective packets of pain relievers in 2008 before recalling the pills months later, after prodding from federal regulators.
The new questions about J&J’s handling of quality issues came during a hearing about its latest recall involving more than 100 million bottles of children’s medicine, some of which contained tiny particles of metal.
“This is an issue of trust – when parents and grandparents give these medicines to their children they want to be confident that they are not harmful,” said Rep. Edolphus Towns, D-N.Y., who chairs the House Committee on Oversight and Government Reform.
Last month J&J’s McNeil division recalled more than 40 varieties of children’s medicines after the Food and Drug Administration discovered a slew of violations at a company plant.
The FDA has not linked the recalled products to any health problems.
Colleen Goggins, J&J’s president for McNeil consumer products, told lawmakers the company has already taken steps to fix the problems, including shaking up its management structure.
But she had few answers to questions about an alleged “phantom recall” of more than 88,000 packets of Motrin, a pain reliever containing ibuprofen. According to FDA documents, J&J learned about a formulation problem in November 2008 that interfered with the pills’ dissolving action, causing them to lose potency.
J&J then hired an outside contractor to collect samples of the product – mainly sold in gas stations – and determine whether a recall was necessary.
But instead of sampling the product, the contractor began purchasing large quantities of Motrin and instructing its employees not to mention a recall.
A memo titled “Motrin Purchase Project,” distributed during the hearing states: “You should simply ‘act’ like a regular customer while making these purchases. There must be no mention of this being a recall of the product!”
Goggins said the FDA was aware of the contractor’s activities, but she couldn’t answer questions about the memo or even why the company was originally hired.
“I can’t tell you about the behavior of those contractors, but the FDA was aware of the action,” Goggins said. “There was no intent to mislead or hide anything.”
FDA’s Deputy Commissioner Joshua Sharfstein said the agency was alarmed to learn about the mass purchases.
“I don’t think we fully understood what was going on, but it was troubling to us,” Sharfstein said, adding that the incident “reflected poorly on the company.”
J&J eventually recalled the lots of Motrin in July 2009 after being confronted by FDA staff.