FDA and Department of Health Address Drug Shortages

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.

In 2010, there were 178 drug shortages reported to FDA, 132 of which involved sterile injectable drugs, according the agency’s frequently asked questions website for its Drug Shortages program. So far this year, there has been “an increasing number of shortages, especially those involving older sterile injectable drugs,” according to the site.

“All parties involved in the supply of drugs to Americans have a responsibility to make sure patients have access to the drugs they need,” states an FDA press release on the subject.

The agency intends to release a report in the coming weeks that analyzes the problem and provides recommendations. “One suggestion is a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which could help to curb drug shortages and improve the continuity of the drug supply,” according to the press release.

“Meanwhile, the FDA will continue its efforts to work with manufacturers to ameliorate shortages. For example, FDA already expedites requests to qualify new manufacturing sites, new production lines or new raw-material suppliers to avert drug shortages. HHS remains committed to working with manufacturers, providers, patient advocates, and other stakeholders to help minimize drug shortages, protect patients, and identify solutions to this serious problem,” said the statement.

FDA will hold a public workshop on Sept. 26, 2011, in Silver Spring, Maryland, to further discuss drug shortages and the Center for Drug Evaluation and Research’s approach for addressing them. The causes and effects of drug shortages, as well as possible strategies for preventing or mitigating them, will be discussed.