Drug Shortages: Overview
In 2011, patients with a variety of ailments - including more than 550,000 cancer patients in the U.S. - were affected by drug shortages. While drug shortages are just recently gaining significant media attention, they have been a growing concern for the past six years.
The Food and Drug Administration (FDA) attributes over half of all drug shortages to quality issues that require plants to temporarily or permanently close. Shortages have been most problematic for sterile injectable drugs, which are more complicated to produce and thus more likely to have manufacturing problems.
Also contributing to the drug shortage problem is consolidation in the pharmaceutical industry, which has resulted in fewer suppliers. When one manufacturer has to shut down even temporarily, the remaining drug manufacturers often aren’t able to quickly produce sufficient supplies to meet the demand. For drugs that only have one supplier, production problems are an even greater cause for concern.
Quality problems alone do not fully explain drug shortages. Sometimes a scarcity of the underlying raw materials slows down drug manufacturing. Halting production of lower-cost drugs when the patent runs out and focusing instead on the production of newer, more profitable drugs is a manufacturing decision that further exacerbates the drug shortage problem. Delays in the FDA’s approval of new manufacturing facilities, processes, and drugs are also a culprit. These problems stem partly from a lack of sufficient funding that would allow the FDA to hire enough inspectors and reviewers, but also from bureaucratic hurdles.