Has your doctor had to change your treatment plan because of a shortage of your cancer drug? If so, you are not alone. Drug shortages, which used to be rare, have been increasing. According to a White House press release October 31, 2011, "While the Food and Drug Administration has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care. A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010, going from 61 to 178."
Now President Obama has signed an executive order designed to reduce the number of shortages in three ways. First, it asks drug companies to voluntarily increase reporting to the Food and Drug Administration of potential drug shortages. Drug shortages can occur for many reasons from problems in the manufacturing process to an actual shortage of the raw material. However, because most of the shortages are of generic drugs while new expensive drugs remain available, many suspect that drug companies could do more to reduce the problem.
In an editorial in The New York Times, oncologist Ezekiel J. Emanuel asserts, "Only the older but curative cancer drugs - drugs that can cost as little as $3 per dose - have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost."
He continues, "Only about 10 percent of the shortages can be attributed to a lack of raw materials and essential ingredients to manufacture the drugs. Most shortages appear instead to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix."
Better advance notice of drug shortages can help the second step of the executive order work: asking other manufacturers to make the drug and speeding approval of new production facilities. Part of this phase of the order increases the FDA personnel needed to handle the increased workload resulting from the reporting system. Increased competition may help reduce shortages.
The third phase of the executive order deals with price gouging. It "directs FDA to work with the Department of Justice to examine whether any secondary drug wholesalers or other market participants have responded to potential drug shortages by illegally hoarding medications or raising prices to gouge consumers. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial - 80 times higher."