Companies have been halting production of a growing number of generic sterile injectables in the past decade. Janet Woodcock and Marta Wosinska, from the FDA’s Center for Drug Evaluation and Research, argue that current economic incentives are driving the drug shortages and ask whether anything can be done.
The US Food & Drug Administration (FDA) reported that 251 drugs went into shortage during 2011. Some 73% of the drugs in shortage were sterile injectables. The sterile injectable shortages included drugs to treat cancer, anesthetic drugs such as propofol, crash cart (trolley) drugs such as epinephrine, and parenteral nutrition drugs used to sustain patients who cannot rely on their gastrointestinal (GI) tract.
The shortages of sterile injectables have followed a common pattern: one or more manufacturers temporarily stop production to address a manufacturing quality problem, most often caused by microbial or particulate contamination. The sterile injectable industry is highly concentrated, and generally just a handful of lines produce a given product. This means that a temporary shutdown of just a single line can cut market-wide production significantly. Because the shortfall is usually quite large and there is limited or no capacity to expand production on short notice, this shortfall cannot be made up by the remaining manufacturers of the product.
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