Sometimes our weekly searches for what is going on in the drug and device world lead as outside the traditional products liability context that is our bread and butter. Occasionally that can be refreshing – a break from preemption and causation and TwIqbal. It’s also interesting to see how things like off-label use come up in different situations. For instance, when a group of doctors sues the FDA alleging they were injured because they could not prescribe a drug the way they wanted. Association of American Physicians & Surgeons v. United States Food and Drug Administration, — F4th –, 2021 WL 4097325 (6th Cir. Sept. 9, 2021). As it turns out, the association did not have standing.
You may recall early on in the COVID pandemic, there was some belief that the drug hydroxychloroquine might help treat the disease. The medical community has since determined that is not so, but this case pre-dates that change in thinking. Hydroxychloroquine has been FDA approved for the treatment of malaria, lupus, and arthritis since 1995. Id. at *1. For COVID treatment, the FDA issued an Emergency Use Authorization permitting the federal government’s stockpile of the drug to be used to treat COVID patients who were hospitalized and for whom a clinical trial was not available or feasible. Id. The Association of American Physicians and Surgeons (AAPS) did not think the authorization was broad enough believing that the best use of hydroxychloroquine was as a prophylaxis before diagnosis or immediately after diagnosis. Id. at *2.
The AAPS brought suit and the FDA challenged its standing to do so. The AAPS alleged it had associational standing – a doctrine that allows an association that has not suffered an injury to sue on behalf of its members who have. Id. at *1. So, the bulk of the opinion is about associational standing, including questioning the doctrine as a whole. Id. at *3-7. But that’s not really what is of interest to us, so we’ll leave it to you to read if you are so inclined.
Our focus is on the injury alleged by the AAPS as the basis for their associational standing. The AAPS claimed that its members were injured because they could not prescribe hydroxychloroquine the way they wanted because of the restrictions of the emergency use authorization. Id. at *9. But the AAPS misinterpreted the FDA’s authorization:
It nowhere barred physicians from prescribing hydroxychloroquine to non-hospitalized patients. Indeed, it did not regulate doctor prescribing habits at all. Rather, it governed distribution of the hydroxychloroquine specifically in the federal stockpile, not of hydroxychloroquine generally.
Id. The reason the court was willing to read the authorization this way was due in large part to the fact that the FDA “regulates drug distribution; it does not bar doctors from prescribing an approved drug . . . for an off-label use.” Id. The Sixth Circuit even cited Buckman v. Plaintiffs’ Legal Comm, 531 U.S. 341, 350-51 (2001) to support the fact that the FDA does not regulate a doctor’s practice of medicine, a function that is left to the states. Id. at *1.
Because hydroxychloroquine was FDA approved and therefore lawfully on the market, physicians could, at their discretion, prescribe it for other purposes, such as prophylaxis or early onset COVID-19 treatment. At most, the FDA’s authorization did not facilitate such off-label use by allowing the government’s own stockpiled supply to be used in that manner. Nothing, however, stopped physicians from prescribing the drug and their patients filling their prescriptions through non-governmental channels. Id. at *9.
The AAPS also tried to argue that they had standing because unidentified state medical boards (the proper regulators of off-label use) might bring some unspecified disciplinary action at some future date based on the FDA’s authorization. But, to confer standing a “yet-to-happen” injury needs to be more than just speculative. Nowhere did the AAPS identify what state law or regulation some physician would be running afoul of by prescribing hydroxychloroquine for COVID outside the hospital context. Id. at *10. Moreover, the AAPS was suing the FDA, not the state medical boards. The FDA could not control or be responsible for the actions of independent actors. Id.
Just another case re-affirming that off-label use falls within the practice of medicine – not the domain of the FDA.