Execution Drugs and Mislabeling
James E. Hamilton | Wednesday, March 30th, 2011 | 1 Comment »
There has been a lot of news lately about the unavailability of drugs used for execution in the United States. The drugs used are normally an anesthetic and a paralytic and then potassium bromide to stop the heart. The drug thiopental produced in the United States, an anesthetic, has been in short supply since some manufacturers have stopped producing it.
Most states that still permit executions and use the three drug method for execution have had issues with domestic supply of thiopental and searched for alternatives. The problem that importers are having with importation of that drug, and with others, is that they are not approved for any indicated use in the United States. While the domestic products are not approved for executions either, they have other approved uses.
In order to satisfy the FDA marketing requirements, the manufacturers of foreign products targeted for the domestic market, must comply with the approval process. This can be costly for a very small market return on investment.
Some states have since substituted for other FDA approved drugs which are available domestically. Regarding misbranding or labeling, none of the products were approved for execution.
James, nice to make your acquaintance.
I suppose the use of an approved drug (demonstrated safe and effective for its labeled indication) for execution is covered under ‘the practice of medicine.’ Of course, it would be impossible (dare I say) to get a drug ‘approved’ for execution, since it wouldn’t be found ‘safe’ for its intended use (unless one could redefine safe for this particular indication) and efficacy would be tough to demonstrate relative to placebo or comparator (I guess it could be done under the Animal Rule…interesting).
Thanks.