BACKGROUND: Drug shortages have been an ongoing problem that has spiraled in the last few years with number of drug shortages increasing almost 300% since 2005. 80% of the drugs currently in short supply are generic injectable medications and many patients have been unable to receive their usual drugs. This has been especially hard for those people with cancer because some of the drugs affected were chemotherapy treatments such as Doxil and others used to treat cancer. Both patients and health care providers are in a difficult situation of having to find alternatives for drugs that just are not available at the moment.
MAIN PROBLEMS: The main problems to be affecting the drug shortage seem to be on the manufacturing side which can be difficult because of regulations on how drugs are made, especially for injectable medications. Some manufacturing plants have even been shut down because of multiple problems in the manufacturing process discovered by the FDA. In the case of Ben Venue Laboratories, inspectors found various problems from metal shards in some of the drugs produced on site to a 10-gallon can filled with urine in the storage room. Due to these issues the lab was shut down in November 2011, and Ben Venue was one of the largest drug manufacturing companies in the United States. However, that is an extreme case and many times the difficulties in the manufacturing process are due to how stringent the requirements for making these drugs are.
WHO’S TO BLAME?: Some have put the blame on the Food and Drug Administration (FDA) for the drug shortages because some believe FDA regulations on manufacturing companies in the United States have made it harder and a longer process for the companies to produce the drugs. When discussing the drug shortage, the House Oversight Committee also said that the FDA is partly to blame for the current situation as their regulatory activities have shut down 30% of total manufacturing power at four of the U.S.’s largest producers of generic injectables. However, others claim the FDA is part of the solution, not the problem and that the responsibility for the drug shortages cannot be placed on any one person or organization.
Drug shortages occur, manufacturers report (according to the Food and Drug Administration's website), because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs. An article in the New England Journal of Medicine laid much of the blame for cancer drug shortages on the way oncologists in private practice operate. (Source: www.cnn.com, The Huff Post)
ASPE ISSUE BRIEF-Economic Analysis of the Causes of Drug Shortages: