Drug Makers Stalled in a Cycle of Quality Lapses and Shortages – NYTimes.com
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.