The Troubling History of Drug Manufacturing Safety Issues

Posted on October 18, 2012

A new report in the New York Times details some of the myriad safety issues uncovered at drug manufacturing plants by the Food and Drug Administration in recent years.

The article was facilitated following the recent outbreak of meningitis tied to a fungal contamination of injectable steroids found at a compounding pharmacy.  As the author goes on to explain, this incident was hardly the first time a drug maker has gotten into hot water. If you’ve been injured or had a loved one suffer a wrongful death due to a defective or dangerous drug, contact the Orange county injury lawyers of Panish Shea & Boyle.

In 2009, the incoming Commissioner of the FDA made the move to make plant inspections more thorough and widespread.  It wasn’t long after that generic drug manufacturer Teva was cited by the organization for issues that apparently compromised the safety of drugs at an Irvine facility.  In particular, propofol had been contaminated with bacteria.

That same year, accusations of deficiencies in quality control leveled against Hospira led to numerous items being recalled.  These items, which were made in plants as wide-ranging as North Carolina, Costa Rica, and right here in California, included things like morphine vials that were overfilled and infusion pumps that suffered from a defect.  Some people have alleged that the deficiencies were the result of a cost cutting measure known as Project Fuel.  This measure is alleged to have led to equipment not being taken care of properly and experienced workers being let go.  Some shareholders were so upset with the initiative that they have filed a lawsuit against the manufacturer.

Hospira disputes the assertion that Project Fuel was about cutting costs.  A spokeswoman said it was more about productivity and making things less complex.

But more organizations have been targeted by the FDA as well.  At a Ben Venue plant, the FDA uncovered mold and rusty equipment.  They also identified a barrel of urine at the facility.  Warning letters have been issued to Sandoz and Luitpold Pharmaceuticals.  And at an A.P.P. Pharmaceuticals facility near Buffalo, internal reports later obtained by the FDA suggest that weevils and even a spider were found inside drug vials.  A former employee says that spiders and centipedes could also be found in areas where manufacturing took place.

Fixing these issues is not a cheap proposition.  Ben Venue will put $300 million toward getting the facility mentioned above back up and running again in accordance with the specifications laid forth by the FDA, and Hospira is set to spend even more.  They estimate it will take $375 million to appease the FDA.

The FDA, for their part, has vowed to work more directly with manufacturers.

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