In today’s mailbag we have questions about FDA regulations and superpower loss. As always, if you have questions or post suggestions, please send them to firstname.lastname@example.org and email@example.com or leave them in the comments.
I. The FDA, Public Emergencies, and Private Cures
Scott asks “Comic book super-brains often find themselves having to create a vaccine against some horrific illness that either comes from space or is created by a supervillain. (Or, on a smaller scale, to help a friend, such as Reed Richards’ ongoing efforts to cure the Thing, or Superman’s pre-Crisis need to rescue Lois Lane and Lana Lang from an accidentally released Kryptonian superbug.) Would there be any issues in dealing with the FDA or would public necessity excuse a lot?”
We’re going to break this down into two sub-issues, public emergencies and private cures, since the issues are different. But before we get into the details, we should mention that necessity is indeed a defense to crimes (the defense of necessity in torts is limited to property torts and isn’t really applicable here). Consent is also a defense in both cases. So even in cases where there aren’t specific exemptions or defenses, those can function as catch-all defenses, though there are important limitations there too.
A. Public Emergencies
In cases where a supervillain releases a terrible disease or toxin (or if they tag along on a meteor) and the public well-being is threatened, a lot of the usual regulations may be waived unofficially. This is particularly true if a superhero delivers a cure in typical comic book fashion (e.g. freely administered, perfect cure rate, no significant side effects, etc). What heartless bureaucrat or overzealous prosecutor would argue with a free miracle cure? Nonetheless, are there provisions for fast-track approval of a treatment in case of a public emergency? It turns out that yes, there are.
In the United States the Food and Drug Administration is responsible for approving new drugs, including vaccines. FDA regulations are given in Title 21 of the Code of Federal Regulations, which is electronically accessible at GPO Access. There are numerous procedures and requirements that can be waived in emergency cases. We’ll discuss a couple of examples.
New drugs are submitted for FDA approval via an Investigational New Drug application or IND. If the application is approved, the clinical trial process starts. Under 21 CFR 312.10, IND requirements may be waived in an emergency. The circumstances justifying a waiver are open-ended. It’s enough that the sponsor (i.e. the applicant) give “Other information justifying a waiver” and that the FDA find that a waiver “would not pose a significant and unreasonable risk to human subjects of the investigation.” In a serious public health emergency it’s easy to argue that the risks of fast-tracking an application are not unreasonable or significant compared to, say, everyone in the world dying of Kryptonian Ebola.
Of course, an approved IND only starts the clinical trial process. What about actually getting the drug approved or at least administering it to patients? If the number of patients that need treatment is small (e.g. there hasn’t been an outbreak yet), then under 21 CFR 312.310 the FDA can permit the treatment of individual patients in emergency circumstances (i.e. patients that aren’t part of a clinical trial but need the drug anyway).
For larger numbers of patients, the FDA can do things like waive the requirements for informed consent under 21 CFR 50.24. This is often done in studies of drugs used in the emergency room where there’s no time to ask, say, a stroke victim to sign an informed consent form. But the regulation is broad enough that it could apply to administering an experimental plague cure to people dying on the street.
B. Private Cures
Generally speaking you can’t give human subjects experimental drugs outside of a clinical trial, so a lot of the same issues discussed above apply to private cures. But there’s another issue: unauthorized practice of medicine. I don’t know if Reed Richards is a licensed physician, but I doubt Superman is. Now, Ben Grimm, Lois Lane, and Lana Lang are unlikely to complain to the police or a prosecutor, so this is more of a theoretical issue, but it’s there.
Finally, physician licensure is done on a state by state basis. A person licensed in state A can’t practice medicine in state B, not even on an emergency basis. So even a superhero who is a licensed physician would have to bear that in mind in case of a national emergency.
II. Superpower Loss
Rae asks “How do you think the law would handle a case in which a mutant (or other powered-being) had lost his powers directly through the actions of another? (e.g. the weaponised “mutant cure” in X3, though I’m sure similar plots have been used in the comics).”
Rae wondered if the law would treat this as a crime against the person (e.g. assault) or as a property crime (e.g. theft). Although we have theorized about treating superpowers as personal property, the courts would probably treat depowering as a crime against the person. In tort it would likely be considered a battery if it was done intentionally.
If, however, the depowering were merely the result of negligence or recklessness, then foreseeability comes into it. For example, if a researcher studying a ‘mutant cure’ negligently releases it into the lab, causing a fellow scientist to lose his or her mutant powers, is that damage foreseeable? What if the researcher didn’t know the scientist was a mutant? The answer here probably hinges on just how common mutants are. If they’re exceedingly rare (say post-House of M) then maybe it’s not foreseeable that a lab accident could cause a mutant to lose his or her powers, since it’s literally one in twenty million or so odds at that point. But if they’re very common (say pre-House of M), then it’s probably foreseeable.
Of course, that still leaves the issue of the measure of damages. How much are superpowers worth, especially if the plaintiff doesn’t really derive income from their powers (e.g. Superman, Batman)? That is a complex topic that’s beyond the scope of this mailbag. We will, however, revisit it in a future post.
That’s all for today. Keep your questions coming in!