The Johnson & Johnson unit responsible for the massive recall of children's drugs is promising to turn over a new leaf as FDA investigates at least 775 reports of adverse events--including 30 deaths--in patients using the recalled meds. Since the recall was announced, the agency has received "several hundred" more reports of side effects, including seven deaths.
The U.S. agency says it has found no "clear pattern" showing the meds caused the adverse events, and officials emphasized that the investigation is ongoing. "At this time, FDA is not aware of any child being harmed by taking one of the recalled products," according to a staff report from the agency. The document was released by the House Oversight and Government Reform Committee, which is holding hearings on the recall this Thursday.
Meanwhile, J&J's McNeil Consumer Healthcare unit is vowing to fix the manufacturing problems that led to the recall--and several others before it. McNeil already has shut down production at the Pennsylvania plant where the children's medicines were made. The company says it has hired an outside consultant to study that plant's operations and identify corrective actions and, at the same time, is developing new processes and procedures, and improving employee training. It's promising to deliver a comprehensive action plan to FDA by July 15 and to check in with the agency monthly on its progress.
And as the Thursday hearings approach, a U.S. senator has joined the fray. Sen. Tom Harkin, who chairs the Senate's health committee, wrote FDA asking for more information on the recall; Harkin wants details on the company's quality controls and suppliers, and he's asking whether FDA has enough power to deal with a situation like this properly. This isn't the first time we've heard that question about FDA empowerment; could this highly public manufacturing mess-up lead to legislation? We'll have to wait and see.