Responding to the Drug Shortage Crisis
Drawing Congressional Attention to the Drug Shortage Crisis
On November 30, 2011, Michelle Hudspeth, M.D., Chief of Pediatric Hematology/Oncology at MUSC Children’s Hospital, testified before Congress about the impact of the drug shortage crisis on children with cancer.
Most affected by the shortage were generic injectable drugs, including anticancer (eg, methotrexate, doxil, leucovorin), anesthetic, and antiviral agents. Especially hard hit were injectable medications for the treatment of pediatric cancer. According to Dr. Hudspeth, children with cancer are particularly vulnerable because generic medications are often the standard of care for these patients: “Only three new drugs have been approved for pediatric cancer in the past 25 years, so the drugs we are using are old drugs, ones that were approved in the 1950s, 1960s and 1970s,” she says.
Generic injectables have been in short supply in part because some companies, faced with shrinking profit margins for generics, have discontinued their production entirely in favor of more lucrative drugs still under patent. Companies may also be reluctant to invest in the maintenance or updating of manufacturing facilities for less lucrative generics. According to the U.S. Food and Drug Administration (FDA), 50% of the 2010 shortages of sterile injectables were related to problems with product quality (eg, presence of particulates, microbial contamination), often due to aging plants (eg, as a source of rust particulates) or quality control problems with the production line.
Made more aware of the gravity of the drug shortage crisis by physicians such as Dr. Hudspeth as well as by the President’s 2011 Executive Order on reducing drug shortages, the federal government and legislators have begun to take action to curb the problem. In 2012, the FDA Safety and Innovation Act was passed, which mandates that manufacturers of certain prescription medications notify the Secretary of Health and Human Services six months in advance of the closing or suspension of a production line that could lead to a drug shortage. If the FDA knows of such disruptions ahead of time, it can take steps to avert shortage by persuading other manufacturers to ramp up production, by expediting review of applications from new producers or, when necessary, by expediting and facilitating the importation of the drug from abroad. As a result of such efforts, the number of new drug shortages fell to 117 in 2012, down from a high of 251 in 2011.
These steps by the federal government and legislature were spurred by the advocacy of physicians such as Dr. Hudspeth, who put a human face on an emerging crisis and, in doing so, helped protect their patients from its potentially devastating consequences.