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http://www.nytimes.com/2012/10/18/bu...anted=all&_r=0
By KATIE THOMAS
Published: October 17, 2012
Lapses at Big Drug Factories Add to Shortages and Danger
Weevils floating in vials of heparin. Morphine cartridges that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and ? in one memorable case ? a barrel of urine.
These recent quality lapses at big drug companies show that contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.
In the last three years, six of the major manufacturers of sterile injectable drugs ? which are subject to rigorous inspections by the federal government, as opposed to compounding pharmacies, which are generally overseen by the states ? have been warned by the Food and Drug Administration about serious violations of manufacturing rules. Four of them have closed factories or significantly slowed production to fix the problems. Nearly a third of the industry?s manufacturing capacity is off line because of quality issues, according to a Congressional report.
The shutdowns have contributed to a shortage of critical drugs, and compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years. Authorities said 19 people had died from meningitis in an outbreak traced to a contaminated steroid made by the New England Compounding Center in Massachusetts. Supplies of the steroid, methylprednisolone acetate, became short earlier this year after two generic manufacturers, Teva and Sandoz, stopped making it.
?In the industry, everyone knows that all of the factories are in terrible shape,? said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. But the public, she said, is still in the dark. ?I think people think this is a foreign outsourcing problem, but these factories are in our own country.? ...
Published: October 17, 2012
Lapses at Big Drug Factories Add to Shortages and Danger
Weevils floating in vials of heparin. Morphine cartridges that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and ? in one memorable case ? a barrel of urine.
These recent quality lapses at big drug companies show that contamination and shoddy practices extend well beyond the loosely regulated compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.
In the last three years, six of the major manufacturers of sterile injectable drugs ? which are subject to rigorous inspections by the federal government, as opposed to compounding pharmacies, which are generally overseen by the states ? have been warned by the Food and Drug Administration about serious violations of manufacturing rules. Four of them have closed factories or significantly slowed production to fix the problems. Nearly a third of the industry?s manufacturing capacity is off line because of quality issues, according to a Congressional report.
The shutdowns have contributed to a shortage of critical drugs, and compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years. Authorities said 19 people had died from meningitis in an outbreak traced to a contaminated steroid made by the New England Compounding Center in Massachusetts. Supplies of the steroid, methylprednisolone acetate, became short earlier this year after two generic manufacturers, Teva and Sandoz, stopped making it.
?In the industry, everyone knows that all of the factories are in terrible shape,? said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. But the public, she said, is still in the dark. ?I think people think this is a foreign outsourcing problem, but these factories are in our own country.? ...