The Department of Health and Human Services released a report containing its analysis of the causes of the escalation in drug shortages seen over the past few years. The report, from the Assistant Secretary of Planning and Evaluation’s Office of Science and Data Policy, coincided with an executive order issued by the White House directing FDA to take specific steps to predict and prevent the drug shortages that have been escalating over the past few years.
The report reiterates that most of the shortages, 132 of the 178 recorded in 2010 were of sterile injectable drugs, including cancer drugs, anaesthetics for surgery, drugs for emergency medicine, and electrolytes for intravenous feeding. According to the report, demand for some of these drugs, particularly oncology drugs, has been rising. The number of vials of sterile injectable oncology drugs shipped between 2006 and 2010 has risen by 14%.
Manufacturing, however, is constrained. The report states that the bulk of sterile injectables is supplied by only 7 manufacturers, and most of the production of a given drug is by three or fewer manufacturers. A dearth of manufacturing capacity is blamed, in part, for the shortages. According to the report, the overall quantity and the range of drugs produced by generic sterile oncology manufacturers over the past 5 years has increased substantially, while the capacity of sterile injectable oncology manufacturing facilities has remained stable. Evidence suggests that manufacturers are diverting capacity from shrinking lines of business, including some of the drugs that have experienced shortages, to growing ones.
The report goes on to say that manufacturing capacity is expected to increase, but that new plants will not come online for another 18 months. In the mean time, the system remains precariously balanced, with unexpected disruptions in supply, such as those caused by manufacturing deviations, likely to result in shortages. The report recommends that FDA expedite the review of new manufacturing facilities, but in the mean time, FDA is focusing its efforts on better prediction. If they get timely notification that a shortage is likely to occur, they can pass the information to other manufacturers, who may be able to divert capacity in time to avert a crisis. An ounce of prevention is worth a pound of cure, especially if the cure is bringing up a new GMP facility.