But it should be noted that there are other health and safety issues facing drug manufacturers. In the last three years, six of the major manufacturers of sterile injectable drugs — which are subject to inspections by the federal government, as opposed to compounding pharmacies, which as stated above are generally overseen by the states — have been warned by the Food and Drug Administration about serious violations of manufacturing rules. Four of the manufacturers 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. These recent quality lapses at big drug companies are a clear indication that contamination and shoddy practices extend well beyond the loosely-regulated compounding pharmacies that have attracted attention because of their link to the very serious outbreak of meningitis.
The manufacturing process garnered more attention in 2009, when Dr. Margaret Hamburg took over as commissioner of the FDA and pledged to get tougher on plant inspections. While she has certainly done that so far, the FDA must take whatever additional steps are necessary to correct a most serious problem. Congress must also appropriate additional funds needed by the FDA so the agency can do its job of protecting the American people.
Source: New York Times
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