In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation of sodium thiopental, the first drug in the three-drug cocktail used in most states for lethal injection (and the only drug typically used in states with one-drug protocols). Since 2009, no domestic company has made thiopental, and the foreign source used by most states is not registered with FDA, which makes it “misbranded” under 21 U.S.C. §§ 331(a), 352(o). In 2011 FDA stated that it wouldn’t block importation of thiopental, using its enforcement discretion. The DC Circuit rejected this approach, holding the statute compels FDA to inspect the drugs and prohibit their importation. The opinion relates to both lethal injections and, less obviously, drug shortages – but though at first glance the implications look potentially significant, I have a hard time seeing how they’ll make much of a practical difference in either scenario.On the lethal injection side, the ruling largely prohibits importation of thiopental — but it’s unclear how much difference this will make. The opinion describes a process of states ordering from UK-based Dream Pharma, which bought it from UK-based Archimedes Pharma, starting in 2009. But in 2010 the UK restricted the export of thiopental to the US, since it’s used only for lethal injections. And, after DEA seizures of thiopental in 2011, most states have stopped using thiopental, switching instead to pentobarbital, which is manufactured by a registered company and imported through normal channels. So lethal injection practices probably won’t change a great deal.
The opinion also relates to how FDA deals with drug shortages, which have been increasing. FDA turns to allowing importation of unapproved drugs as a last resort in about 5% of cases (pdf), when domestic manufacturers can’t pick up the slack and other options like expediting review don’t work. FDA argued that this allowance is the same enforcement discretion as in the thiopental situation, and that prohibiting the one will block the other – but the DC Circuit rejected this argument squarely: “In any event, even if reading § 381(a) by its terms, as we do, deprives the FDA of one possible response to five percent of all drug shortages, that is hardly an absurd result.” Slip op. at 16.
I think the court’s judgment of FDA’s actions is a little blase here – it’s not just one response in 5% of cases, but what seems to be a last-ditch effort when all else fails. FDA has allowed just 17 importations since 2010, the last being 3 injectable nutrition drugs used to treat cancer patients and premature infants. However, the end result may be relatively unproblematic – FDA can probably work around the prohibition requirement by, for instance, designating an unapproved foreign drug as an investigational new drug (IND) so it can be importated (slip op. at 16, citing 21 U.S.C. § 355(i). It’s not entirely obvious to me why the statutory section authorizing INDs “intended solely for investigational use” has much wiggle room to encompass non-investigational treatment purposes, even though 21 CFR 312.315(a)(3)(ii) says it’s OK – but I have a hard time seeing who would challenge such an importation.
