When Hospira stopped manufacturing sodium thiopental, which is used in lethal injections, it caused a drug shortage, and states began looking for alternate suppliers. At first, the developments made me wonder whether FDA should oversee nonmedical uses of drugs. Now the shortage has led to a federal lawsuit that raises questions about the way the agency controls imported drugs.
Last Wednesday, an attorney filed a lawsuit on behalf of death-row inmates in California, Arizona, and Tennessee, asking a judge to block imports of sodium thiopental. The suit alleged that FDA knowingly allowed these states to import the drug from manufacturers that the agency had not approved. Furthermore, the lawsuit alleged that FDA neglected its duty to inspect shipments of the drug.
The focus on the drug manufacturer reminds me of FDA’s poor record of conducting overseas inspections. A September 2010 report from the Government Accountability Office (GAO) observed that the agency had inspected only 11% of foreign drug manufacturers in 2009. Furthermore, FDA failed to follow GAO’s recommendation that it inspect the sites that posed the greatest risk to public health.
Nebraska, whose inmates are not parties to the lawsuit, purchased sodium thiopental from an Indian supplier after Hospira ceased producing it. Although FDA has an office in India, it is not equipped to do on-the-ground oversight. Nebraska’s supplier is thus not likely to have been inspected.
For FDA to anticipate and mitigate drug shortages, it requires a solid and effective way of guaranteeing the safety of imported drugs. Unfortunately, the new federal lawsuit raises difficult questions about how well the chronically understaffed and underfunded agency can perform this task.