By John W.M. Claud & Deborah L. Livornese & Charles D. Snow —
On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA.
The genesis of this lawsuit is a disagreement over regulatory language and, more significantly perhaps, statutory interpretation. Sometimes two people can look at the same thing but have entirely different understandings of it. Maybe you recall the viral blue dress/yellow dress internet sensation. Or maybe in high school English class you discussed whether The Turn of the Screw was a ghost story or a cautionary tale about mental illness. It’s a dessert topping; no, it’s a floor wax.
This lawsuit has FDA and the homeopathic health community looking at the same provisions of the 2020 CARES Act from vastly different perspectives. The plaintiffs are suing FDA over its December 2022 final guidance, “Homeopathic Drug Products,” which we discussed here. In the final guidance, FDA pronounces that homeopathic cures must obtain new drug approvals or exist in the uncertain realm of FDA’s exercise of enforcement discretion.
The recent suit has its origins in FDA’s re-evaluation of its homeopathic enforcement policies, which began at the Agency in 2015 in light of the growth of the industry. In 2017, FDA issued a draft guidance describing how it would apply its standard “risk-based” assessments to enforcement and regulatory actions in this space, which we also discussed in a previous post. FDA’s issuance of the draft guidance marked a shift in its decades-long policies that largely permitted the marketing of over-the-counter (“OTC”) homeopathic products. The next step in this shift of policy was FDA’s withdrawal in late 2019 of its 1998 Compliance Policy Guide (“CPG”) 400.400, discussed here. The withdrawal of this CPG immediately drew ire from the homeopathic industry, which believes the CPG was and is a far superior regulatory policy than enforcement discretion.
In 2020, the CARES Act reformed and modernized the OTC drug review process. Before enactment of the CARES Act, FDA issued regulations to add, remove, or make changes to OTC monographs based on whether they were generally recognized as safe and effective (“GRASE”). After enactment of the CARES Act, FDA began using administrative orders to accomplish the same task. However, the CARES Act specifically excluded homeopathic products from the OTC drug review. § 3853 CARES Act. From this exclusion the conflict arises.
Industry saw FDA’s issuance of the final guidance as an escalation of the Agency’s prior, arguably lenient approach to the continued marketing of unapproved homeopathic drugs. FDA has never assessed any homeopathic drugs under the OTC drug review, and thus has never made any GRASE determinations about any of them. This exclusion was in response to a request from the homeopathy industry when the OTC drug review was first adopted in 1972. Then, FDA stated that it “decided to exclude homeopathic drugs from this OTC drug review and to review them as a separate category at a later time after the present OTC drug review is complete.” 37 Fed. Reg. at 9466 (May 11, 1972). FDA had had little knowledge how long the OTC drug review would take to complete, as of course, that day remains in the future. But based on its current position, the Agency reads the CARES Act exclusion to mean that to be on the market, homeopathic drug makers continue to need to have either an approved drug application (NDA or ANDA) or operate at their own peril under FDA’s risk-based enforcement framework.
The homeopathic community has a completely different take on the CARES Act exclusion and does not see it as a continuation of the status quo vis-à-vis homeopathic drugs. It believes that Congress excluded their products with the intention of easing the path of homeopathic drugs to market, not to make that process harder—perhaps impossibly so—under the rigor and expense of an NDA. Thus, in their suit, the plaintiffs argue that by “concluding in the [2022] Final Guidance that all homeopathic drugs are subject to premarket drug approval requirements, the FDA has foreclosed practical channels to market OTC homeopathic drugs.”
Invoking Loper Bright, the plaintiffs ask the D.D.C. to deprive FDA of judicial deference and make the decision. The suit also asks for several forms of relief that judges were loath to provide in similar cases pre-Loper Bright. Here, plaintiffs are also asking for judicial declarations that drugs marketed under a unique homeopathic monograph are not new drugs, that OTC homeopathic drugs are excluded from pre-market approval requirements, and that the 2022 final guidance violates the Due Process Clause. Lastly, the plaintiffs want an injunction against FDA to prevent it from taking enforcement action against OTC homeopathic products.
The plaintiffs and FDA are both looking at the same language in the CARES Act and are seeing diametrically opposite meanings. As this Jamesian controversy plays out in the Courts, we’ll provide updates in future posts.
