When I hear, “FDA,” I generally think of the government regulator of serious, potentially dangerous drugs: thalidomide, fen-phen, tasmar. I typically don’t think of hand soap. But if you, like millions of others around the world, use certain antibacterial hand soaps, you’re in fact using an FDA regulated “drug.” The problem is that with respect to certain antibacterials, the FDA has never finalized its regulations of those drugs. And due to a rather peculiar procedural loophole, those drugs have entered the market without the FDA determining that they’re either safe or effective. The FDA’s failure to finalize that determination–and the plaintiffs’ standing to challenge it–were precisely the issues presented in Natural Resources Defense Counsel v. FDA, decided by the Second Circuit last week.
So, first: If antibacterial products are “drugs” as far as the FDA is concerned, how could they enter the market before the FDA “approval”? It works like this: New, over-the-counter (“OTC”) drug products can’t be sold until the FDA determines that they’re “general recognized as safe/effective,” or GRAS/E for their labeled used. To speed the introduction of some OTC drugs onto the marketplace, the FDA publishes what are known as “monographs”–essentially long lists of permitted ingredients–for each therapeutic class of drug products. The monographs list under what conditions those drugs would be considered GRAS/E. Like everything else the FDA does, the monographs are subject to notice and comment, and are not “final” until the FDA says so. The FDA may, however, allow drug products to be sold OTC while the finalization of their respective monographs are pending.
That is precisely what happened with the two antibacterials in Natural Resources Defense Counsel v. FDA, the drugs triclosan and triclocarban. (If you’re a label reader, you may recognize these names–they’re the antibacterials in Dial soap.) Both are listed under the monograph “topical antiseptic antimicrobial drugs.” Even though these products have been on the market for years, the FDA has yet to finalize either’s monograph–and in triclosan’s case it’s been pending for thirty-five years. See 43 Fed.Reg. 1210 (Jan. 6, 1978). With the health effects of frequent exposure to these drugs unknown, and with the recent rise in antibiotic resistance, the Natural Resources Defense Counsel (NRDC) brought suit against the FDA to force them to finalize these regulations.
Now, second: How does an outfit like NRDC get to challenge what is essentially the FDAs failure to do something? Well, under the Administrative Procedure Act (APA) almost anyone can challenge an agency’s failure to take a specific, statutorily authorized action if they were harmed in that agency’s dereliction of its duties. But what the individual, or group of individuals, must first prove, is that she has standing; that is, that she was actually or will be imminently harmed by the agency’s failure. So, in challenging the FDA’s decision not to finalize triclosan’s and triclocarban’s monographs, the NRDC needed to prove that it was actually or imminently harmed by that delay.
Regarding triclosan, the NRDC attempted to demonstrate standing by submitting the declaration of Diana Owens, one of its members and a veterinary technician. As one can imagine, veterinary technicians must–and should–wash their hands frequently on the job. In Ms. Owens case, this means something on the order of fifty times a day. Because her employer essentially mandated that she use triclosan-containing soap (which I guess, from the opinion, were troughs of Dial soap from Sam’s Club), she was rightfully concerned–especially after several studies suggested that triclosan may play a role in aberrant hormone production. For the Second Circuit, this was enough to demonstrate that she was imminently harmed for standing purposes.
More interesting, however, was the Second Circuit’s rejection of NRDC’s standing on its triclocarban claim. That harm of that claim was not predicated on any endocrinological injury, but on the theory that triclocarban increases the risk of being infected with antibiotic resistant bacteria. Breaking down the claim in chronological parts, the NRDC essentially alleged the following: that the FDA’s delay in finalizing triclocarban’s monograph (now, nineteen years and running, see 59 Fed. Reg. 31402 (June 17, 1994)) has led to its widespread adoption in antibacterial soaps; frequent users of those soaps breed antibiotic resistant bacteria; and the NRDC, and its members, may become infected with those bacteria and be unable to cure themselves of their infections. The Second Circuit rejected this standing argument as too remote:
The claim that the proliferation of triclocarban may lead to the development of antibiotic-resistant bacteria, in contrast, involves unspecified bacteria or microbes that NRDC members may not ever come into contact with. And in order for those bacteria or microbes to harm plaintiffs, there must bean intermediate step in which triclocarban causes those bacteria to become resistant to antibiotics.This claim thus seems less like a present injury and more like a threatened injury that is contingent and far-off rather than imminent. We therefore conclude that NRDC lacks standing as to the regulation of triclocarban.
Slip op. at 12. It’s unclear what the FDA will do next. For practical reasons–because triclosan and triclocarban are likely to be published in the same monograph–if the plaintiffs win at trial, the FDA may just finalize its regulations concerning both drugs. Dial soap, at least in its antibacterial form, may come off the market. (Although that will almost certainly not be for years, if ever.) But the take away point from the Second Circuit’s decision is a frightening one: injury that stems from an increased risk of exposure to virulent, antibiotic-resistant strains of bacteria is not injury enough for the APA’s purposes. This seems like poor policy even if it’s law, logically applied to precedent, because there are truly few other more pressing public health concerns–public health concerns that, unlike drug innovation policy, could actually be addressed through restrictive regulation–than antibiotic resistance. The problem lies in how the FDA views its own responsibilities: getting safe and effective drugs to market–greater public health consequences of those drugs be damned. Hopefully, some fix, be it administrative, executive, or statutory, can address this glaring gap in the FDA approval process. But in the meantime, if the NRDC can’t challenge the FDA’s slothfulness when it comes to antibiotic resistance, then who can?
And for that matter, if you can’t trust the FDA to get soap right, then what can you trust? For now, I’m sticking to Purell.