Report: Drug Shortages Persist, Despite FDA Efforts
MARCH 11, 2014
The FDA has used its recently increased power to combat drug shortages nimbly, but so far the agency has not succeeded in reducing the overall number of shortages, according to a report released by the Government Accountability Office (GAO) on February 10, 2014.
The FDA was given additional authority to fight shortages in the 2012 Food and Drug Administration Safety and Innovation Act, which requires manufacturers to alert the FDA of potential shortages before they happen.
The GAO determined that the FDA prevented 154 potential shortages in 2012 compared with 35 in 2010. In addition, the number of new drug shortages declined in 2012 for the first time in years. However, the overall number of shortages continued to increase, reaching 456 in 2012, compared with 154 in 2007.
Regulatory discretion is one tool the FDA has used to prevent shortages. For instance, if batches of a drug in shortage are found to have particulate contamination, the manufacturer might be allowed to filter them rather than have its plant shut down.
In a congressional hearing on the report, an FDA official testified that approximately two-thirds of shortages are due to quality problems and the need to fix them. Small profit margins are also a problem, leading manufacturers to put off maintenance and emphasize production of products that make more money.
In the report, the GAO praised the FDA for its efforts, though it noted that the agency cannot force production of particular drugs. In addition, it urged the FDA to work to identify patterns in shortages to help it better predict when they are going to happen.