Congress Wants FDA To Probe J&J Outsourcing

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best-sweetThe ongoing recall scandal enveloping Johnson & Johnson is being widened to include companies that make products for the beleagured healthcare giant and still other drugmakers. In a letter sent late last week to the FDA, Darrell Issa, the ranking Republican on the House Committee on Oversight and Government Reform, noted that 13 million chewable Rolaids packages, which were tainted with metal and wood particles, were made by an outside contractor known as Best Sweet.

And so Issa demanded dthat FDA commish Margaret Hamburg, who he has already asked to probe manufacturing plants in Puerto Rico (see this), start looking at companies that manufacture over-the-counter meds and related contract manufacturing, in general (read the letter). The move has the potential for raising the ante considerably for Johnson & Johnson, in particular.

The huge list of manufacturing problems and subsequent recalls (look here) prompted one Wall Street analyst to forecast that Johnson & Johnson’s Puerto Rico facility could be closed and about $1.2 billion in sales lost next year, or twice what the health care giant is expected to lose this year thanks to the shutdown of its Fort Washington, Pa., facility, where consultants are working furiously to retool the troubled plant.

To cope, Johnson & Johnson was expected to increasingly rely on outside contractors to fill the gap. Now, though, this tactic is likely to come under additional pressure. Best Sweet, by the way, makes over-the-counter meds, candies and supplements, and its clients include the CVS chain of pharmacies and Baskin-Robbins, according to its web site. The contractor has denied any manufacturing issues, but Issa wants the FDA to examine the contractor for any sign of problems supplying Johnson & Johnson or any other company.

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