Health Inc.

Johnson & Johnson Accepts Government Oversight Of Key Factories

If anyone is surprised by news that Johnson & Johnson has agreed to put some factories where it makes over-the-counters medicines under strict supervision by the federal government, well, you just haven't been paying attention to the company's persistent trouble meeting basic quality standards.

The company's McNeil unit, marketer of such medicine chest mainstays as Tylenol and Sudafed, entered into a consent decree with the Justice Department Thursday that will keep three factories — two in Pennsylvania and one in Puerto Rico — firmly under the government's thumb for at least five years.

For J&J, things could have been worse. There was no fine imposed. And only two employees — vice presidents for quality and manufacturing at McNeil— were named personally, putting them on the line in case the company messes up again.

Quality problems at McNeil factories have led to so many recalls of medicines, there's a special website rounding up the affected products. Despite a whole lot of promises made by J&J to the Food and Drug Administration that the company would clean things up, the government's complaint says:

[R]recent FDA inspections have confirmed that violations persist and additional work is needed to fully address the deficiencies and achieve sustained compliance with the law.

A factory in Fort Washingon, Pa., that was at the center of problems with children's medicines, remains out of action and won't return to production unless the FDA gives it the OK.

The decree spells out specific deadlines for J&J to make changes and includes a financial hammer if the company screws up. The FDA has the power to stop McNeil factories cold, recall products, and to impose fines up to $10 million annually.

Oh, and J&J will have to pay for the FDA's time spent inspecting the factories and testing medicines. In case you're interested, each FDA inspector bills $87.57 an hour. Lab work is pricier: $104.96 an hour.

The consent decree has to be approved by the U.S. District Court for the Eastern District of Pennsylvania. There's no reason to think that won't happen.

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