Tuesday, January 4, 2011

Mystery Solved -- FDA/CBP Allows States To Import Drugs For Lethal Injections

The Arizona Republic is reporting that the FDA is exercising "enforcement discretion" to allow states to import drugs used in lethal injections even when produced in non-FDA approved facilities.  According to the article:
An FDA spokeswoman told The Arizona Republic last week that the agency would "continue to defer to law enforcement on all matters involving lethal injection," suggesting that the agency will allow states to continue to import the drug from abroad.
The article goes on to describe how Arizona imported the drug and counseled other states on how to go about doing so:

In late November, Britain imposed a ban on thiopental exports for use in capital punishment. In December, the Italian government passed a similar resolution.
Also in December, the California Department of Corrections and Rehabilitation was ordered by a judge to release details of its acquisition of thiopental after being sued by the American Civil Liberties Union. California disclosed its source: Arizona's Corrections Department. In late September, officials from California had driven to Arizona to obtain the drug.
Arizona corrections officials coached their California counterparts on a "bulletproof" means of obtaining the drug.
According to an e-mail from Corrections Deputy Director Charles Flanagan to California officials, Arizona used a local customs broker to obtain the drug from a British pharmaceutical-supply house. Then, Flanagan said, it was necessary for the shipment to go through customs in Phoenix, not in Memphis, Tenn., where the shipment would first arrive via Federal Express. That would give jurisdiction to local customs officials, not those in Memphis.
An FDA officer from Los Angeles signed off on the shipment, according to court documents. Whether the decisions to admit the shipment were made locally or higher up in Customs and the FDA is unclear. Neither agency has yet released that information.
Homeland Security Secretary Janet Napolitano, whose agency oversees U.S. Customs and Border Protection, told The Republic that the question did not go as high as her office.
In a series of e-mails to The Republic last week, FDA spokeswoman Shelly Burgess wrote: "Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA's explicit public-health role. FDA does not verify the identity, potency, safety, or effectiveness of substances imported for this purpose. FDA exercises similar enforcement discretion when these drugs are manufactured and purchased within the United States."
I've previously blogged about the prohibitions against importation of drugs manufactured in non-FDA approved facilities located outside the United States ("Buying Medicine From Outside the U.S. Is Risky Business" Especially For Death Row Inmates) and raised questions about how Arizona obtained the sodium thiopental:

what I really want to know is how was the thiopental sodium imported into the United States.  Perscription drugs (and controlled substances) such as sodium thiopental  can only be imported into the United States if they are produced at FDA-approved facilities.  There are no foreign FDA-approved facilities for sodium thiopental.  Therefore, it's unclear how someone could have formally declared the drugs and imported them into the United States.  Did someone "informally" import the sodium thiopental  in their carry-on luggage and make it available for sale to states?  I sure hope not.
Well, now we know.  The FDA has decided to create a de facto "lethal injection" exception to the statutory prohibition against importation of drugs produced in non-FDA facilities.  In effect, what the FDA is saying is that it won't prohibit the importation of these drugs by states that intend to use them in lethal injections because these are "off label" uses and so the FDA has no interest in ensuring that the drugs are safe and effective.  I suspect the recipients of the drugs feel differently.