Obama Signs Executive Order Addressing Rising Shortages of Rx Drugs

On Monday, President Obama issued an executive order intended to address a rising number of shortages for medications that treat life-threatening illnesses, the AP/Washington Post reports (AP/Washington Post, 10/31).

The order instructs FDA to:

• Require broader reporting of potential shortages for certain drugs;
• Speed reviews of applications to begin or change production of the drugs; and
• Provide the Department of Justice with more information about possible price gouging and collusion (Harris, New York Times, 10/31).

Background

In September, HHS officials testified during a House Energy and Commerce Subcommittee on Health that such shortages could result in a major health crisis. According to the testimony, 178 drug shortages were reported to FDA in 2010, nearly three times the number reported in 2005.

So far in 2011, there have been even more shortages of "medically necessary" drugs, including drugs used to treat lymphoma, leukemia and breast cancer, as well as antibiotics, anesthetics and electrolytes for patients on IV feeding tubes.

Both Democrats and Republicans questioned whether government interference with the forces of supply and demand has exacerbated the shortage, and they stressed continued compromise with the administration going forward.

A bill (HR 2245) introduced by Rep. Diana DeGette (D-Colo.) would require drugmakers to alert FDA when they expect a shortage (California Healthline, 7/13).

Details on Executive Order

Obama is expected to voice his support for the House and Senate to expand reporting requirements (Bohan, Reuters, 10/31).

The executive order is expected to strengthen FDA's shortages team to handle more detailed communication with drugmakers about events that could have an effect on drug supplies.

In addition, the administration plans to send letters to drugmakers to remind them about their legal obligation to report potential supply disruptions and to notify FDA of events that could lead to shortages.

Reports Finds Shortages Caused by Market Dysfunction

The administration also plans to release two reports that attribute drug shortages to market dysfunction, the Times reports.

The studies found that about 74% of drugs affected by shortages last year were sterile injectibles. Almost 50% of the shortages occurred after inspections found serious quality problems, such as injectibles with glass shards, metal filings and bacterial contamination.

About five large hospital buying groups purchase about 90% of the needed medications and seven companies manufacture the majority of medications. The reports also note that in many cases, one drugmaker produces at least 90% of a drug's supply (New York Times, 10/31).