President Obama is directing the U.S. Food and Drug Administration to reduce and prevent prescription drug shortages, as well as prevent price gouging.
The number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010, according to a press statement by the White House. Recent shortages have included drugs to treat cancer and fight infection from bacteria.
The executive order directs the FDA to broaden reporting of potential shortages of certain prescription drugs, and to expedite regulatory reviews that can help prevent or respond to shortages. Under the order, the FDA will also work with the Department of Justice, to examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications.
On its Drug Shortages Webpage the FDA states that:
The agency works closely with manufacturers of drugs in short supply to communicate the issue and to help restore availability. FDA also works with other firms who manufacture the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage. Manufacturers are not required to report information, such as reasons for shortages or the expected duration of shortages. However, many companies voluntarily provide shortage information that FDA posts on its website.
The executive order is the first since 1985 by a president to affect the functions of the FDA, according to the New York Times. The executive order also directs the FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages. The White House press release acknowledges, however, that many of the causes and solutions to the drug shortage are actually outside of the FDA’s authority, such as additional manufacturing capacity in the private sector.
In addition to signing the executive order, the White House also announced that President Obama supports bipartisan legislation that also addresses the prescription drug shortage, and aims at strengthening the FDA’s ability to prevent such shortages.
FDA says cancer-drug shortage is getting worse
FDA reports shortage of ADHD drugs
President Issues Executive Order, Backs Legislation to Require Drug Companies to Report Shortages [Whitehouse.gov]
Obama Tries to Speed Response to Shortages in Vital Medicines [New York Times]
Drug Shortages [FDA]