The increasing number of shortages of medically-necessary pharmaceuticals, and of generic injectable drugs in particular, drew the attention of the US Congress and FDA in separate public hearings held in late September.
The forums provided the opportunity for the Senate and FDA to hear from government and industry experts on the causes and potential solutions to the drug shortage problem. A divergence of views were expressed on the main drivers of the problem and, in turn, what can be done to address it.
According to FDA’s Center for Drug Evaluation and Research (CDER), the number of drug shortages has been rising steadily over the last five years. 61 shortages were reported by CDER in 2005 compared to 178 in 2010. This trend has continued into 2011 and the total is again expected to increase for the year.
Generic sterile injectables make up an increasingly large share of these shortages, although they comprise only a small percentage of the overall prescription drug market.
The drugs in short supply include critical products such as oncology drugs, anesthetics, parenteral nutrition drugs, and many drugs used in emergency rooms. Oncology drugs account for 28 %of shortages followed by antibiotics at 13 %. During 2010 and 2011, one hundred eighteen shortages (93 %) involved “medically-necessary” drugs and 52 of the shortages (41 %) were both medically necessary and sole source drugs.
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