On October 31, 2011, President Obama signed and released an Executive Order directing the FDA and the Department of Justice to take actions designed to reduce prescription drug shortages, protect consumers, and prevent price gouging regarding certain prescription drugs. http://www.c-span.org/uploadedfiles/Content/Documents/wh103111_prescription-drug-order.pdf
This Executive Order directs the FDA to expand and help expedite (i) reporting of potential drug shortages, including through the use of expanded advance notice requirements, and (ii) review of new manufacturing sites, drug suppliers and manufacturing changes, all with a view toward preventing shortages of certain medicines. These medicines include cancer treatments, anesthesia, and other medicines “that are critical to the treatment and prevention of serious diseases and life threatening conditions.”
In addition, the FDA is to report to the Department of Justice, for its review and consideration “any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices.”
The issuance and release of the October 31, 2011, Executive Order is the first step in a process that will include the release today of (a) a letter to drug manufacturers reminding them of their drug shortage reporting responsibilities, (b) a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation assessing the root causes of drug shortages, and (c) a report from the FDA assessing and defining its role in “monitoring, preventing and responding” to shortages.
The Executive Order, the first since 1985 to directly affect the operations of the FDA, as well as the related actions implemented today, are intended to address the growing number of shortages of critical drugs through expanded notification requirements, expansion and expedition of approvals and further reporting to, and involvement of the Department of Justice in potential price gouging situations. At present there are approximately 180 qualifying drugs that are in short supply, including drugs that treat childhood leukemia, breast cancer, colon cancer and severe infections.