The Johnson & Johnson children's drug recall has spawned a congressional investigation, of the company's performance on one side and of federal regulators on the other, the Washington Post reports. Spearheading the inquiry are Reps. Edolphus Towns and Darrell Issa, who head up the House Committee on Oversight and Government reform.
Apparently, the sheer size of the recall gave the lawmakers pause: It affects some 70 percent of the market for over-the-counter children's liquid meds. Another impetus was press coverage of the recall, which raised some questions, the representatives say in a statement. "FDA and McNeil Consumer Healthcare have given conflicting accounts of the circumstances surrounding the recall, including what prompted the recall and how serious the recall is," the statement reads.
Some questions the committee intends to ask: Are the FDA's inspection procedures adequate? Did J&J unit McNeil Consumer Healthcare ignore consumer complaints that could have tipped them off about manufacturing problems? "It is our responsibility to ... [ask] tough questions about the conditions of the manufacturing plant and controls put in place by the drug company's management," the statement reads, "and about whether FDA's inspection and recall procedures were sufficient."
This new probe comes on the heels of an FDA inspection report that cited numerous problems at the McNeil plant where these liquid medications were made. Inspectors found dust and grime, contaminated raw materials and other "serious" issues at the facility, which the company has since closed so it can correct the problems. Hearings are to come, so no doubt we'll hear much more about this plant as the weeks wear on.
- Read the House committee release
- see the Washington Post story
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