Executive order aims to accelerate FDA action
October 31, 2011
President Obama on Monday is expected to issue an executive order intended to address a rising number of shortages for medications that treat life-threatening illnesses, the AP/Washington Post reports.
Overall, 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. HHS officials testifying at a House Energy and Commerce Subcommittee on Health in September said the shortages could result in a major health crisis.
Obama’s order will instruct 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.
Obama also is expected to urge the House and Senate to expand reporting requirements and announce plans to strengthen FDA’s shortages team in order to handle more detailed communication with drug makers about events that could affect drug supplies. In addition, the administration plans to send letters to drug makers reminding them of their legal obligation to report potential supply disruptions and notify FDA of events that could lead to shortages.
Reports finds shortages caused by market dysfunction
The administration on Monday also plans to release two reports that attribute drug shortages to market dysfunction, the New York 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 group purchasing organizations buy about 90% of the needed medications. Meanwhile, seven companies manufacture the majority of medications. The reports note that one drug maker often produces at least 90% of a drug’s supply (AP/Post, 10/31; Harris, Times, 10/31; Bohan, Reuters, 10/31