Limitless

[amazon_link id=”B005DD7MH8″ target=”_blank” container=”” container_class=”” ]Limitless[/amazon_link] opened this weekend, and is the subject of Law and the Multiverse’s second look at a movie. Spoilers to follow, as always.

The basic premise is that Edward Morra (Bradley Cooper) stumbles across a drug, “NZT,” which massively boosts one’s memory and intelligence. This enables him to write his unstarted-and-overdue book in a matter of days, learn any language in a matter of hours, and become a concert-level pianist in a long weekend. So basically, what we’ve got here is every nerd’s fantasy: if I was only smart enough, I’d be able to get the money and the girl.

The movie has been described as “more interesting than it has any right to be,” which is about right. But there are a number of legal issues in the movie to talk about, mostly about the drug itself.

First, a high-level overview of how drugs are regulated in the US.  For a drug to be legally prescribed or distributed it must be approved by the Food and Drug Administration.  Clinical trials for new drugs must also have FDA approval.  Some drugs are further restricted by the Controlled Substances Act, which establishes a schedule of controlled substances, some of which can be prescribed by a doctor with a DEA number and some of which are banned outright (e.g. heroin).  Finally, individual states can add to (but not subtract from!) the federal controlled substances schedule.  Now we’ll look a little closer at how all of this affects NZT.

I. The Food and Drug Administration

It is illegal to sell, for human consumption, any pharmaceutical product which has not been approved by the FDA, which may be marketing approval or approval of a clinical trial. This is why pharmaceutical companies spend so much time and money on the approval process: one bad trial can mean millions in R&D going down the tubes. The FDA was (more or less) created by the Pure Food and Drug Act of 1906, later replaced by the Food, Drug, and Cosmetic Act of 1938. These and later acts make it a crime to market or distribute any drug (or medical device, food additive, or dietary supplement) without FDA authorization. The approval process for each category is different, which is why almost anybody can sell a dietary supplement, provided they do not make claims which would suggest that it is a drug and it isn’t drug-like enough to make the FDA want to categorize it there regardless of claims.

Still, as soon as the FDA got wind of this, you can bet that they’d take action, probably including bringing in the DEA, to see that the creation and distribution of this drug was brought under federal oversight. This isn’t entirely a bad thing, either. Sure, the War on Drugs is notoriously problematic from a civil liberty, social policy, and even race relations standpoint, but the real objection is that the government is misclassifying drugs, not that it shouldn’t be classifying drugs at all. In the nineteenth century, there really was no regulation on any of this stuff, so a drug containing heroin could not only be marketed freely, but without any indication that it contained heroin. A consumer could get addicted to a powerful narcotic without even realizing that they were using it. This, obviously, is not an ideal situation. Similarly, without regulating pharmaceutical manufacturing, companies could use unsanitary facilities or dangerous ingredients in their products without anyone knowing or being able to do anything about it. Again, not a good outcome. So even if we think that our approach to certain interesting substances needs to be re-evaluated, deregulating them entirely is probably not the best option.

So would the FDA ever approve something like NZT?  Probably not, though theoretically it could, and if it did it wouldn’t approve it for average people like Edward Morra.  The FDA most often approves drugs that treat, diagnose, or prevent diseases.  Since having average intelligence is not a disease, the FDA would be reluctant to approve NZT unless it had virtually no side effects.  Since it apparently kills people who stop taking it, approval is unlikely.  The FDA could limit NZT’s approval to use by people with development disabilities, but it’s also rare for the FDA to approve drugs that people have to take for the rest of their lives.  Usually such drugs are only approved for life-threatening conditions.  NZT would definitely struggle for regulatory approval.

II. The Controlled Substances Act

Many drugs, both approved and unapproved, are regulated under the Controlled Substances Act, which operates in two primary ways. The statute itself includes a list of scheduled substances, and it empowers the attorney general to modify the schedule, although in practice the schedule is modified by the Drug Enforcement Agency as informed by the FDA. The statute lays out the criteria by which substances are to be categorized into different schedules, but other than the drugs which Congress has scheduled by legislation, the statute basically lets the attorney general issue his or her own findings as to which drugs belong where.

Schedule I substances are basically illegal entirely, i.e. illegal to create, distribute, or possess. They have a high potential for abuse, no currently accepted medical use, and are unsafe to use even under medical supervision.  There are rare exemptions given for research, but that’s about it.  Schedule I includes things like heroin, marijuana, LSD, methaqualone (Quaalude), and a host of hallucinogens.

Schedule II includes drugs which have a potential for abuse which is less than those on Schedule I, and can be prescribed under certain circumstances. Cocaine, believe it or not, does fall here, as it is occasionally used as a topical anesthetic even today. Oxycodone, morphine, and most of the other narcotics fall in this schedule, as do amphetamines.

Schedule III is, again, less serious than Schedule II, etc., all the way down to Schedule V, which includes some substances (such as cough syrup with codeine) which are actually available over-the-counter in other countries.  It should be noted that most prescription drugs are not scheduled at all.

NZT is obviously something that would be scheduled by the appropriate federal agency—probably the FDA—and given its properties would be a good candidate for either Schedule I or II. It appears highly addictive, or at least the people who stop taking it tend to die, though it could potentially have a legitimate medical use. Giving it to developmentally disabled persons might enable them to live normal lives, for example, and as NZT is not said to have any adverse side effects other than dependency, the FDA might theoretically approve such a drug if a proposal were submitted. Either way, Eddie is taking it without a prescription. Is that illegal?

Maybe, maybe not.  It depends on how closely related NZT is to a known controlled substance. The federal government and many states have passed what are generally referred to as Analog Acts (e.g. the Federal Analog Act).  These laws attempt to regulate substances that are substantially similar to known controlled substances.  We say ‘attempt’ because the courts are not in uniform agreement as to whether such laws are valid or not.  In an effort to broaden the reach of the laws the legislatures tended to draft them very generally, to the point that some courts have held them void for vagueness, which is a rare but serious defect in a criminal law.  And this makes sense: for a criminal law to work people have to know what, exactly, is being criminalized.

But let’s assume that NZT is an entirely novel substance.  Certainly there’s nothing similar on the market, so that seems like a reasonable assumption.  New controlled substances need to be placed on the list via legislation or administrative procedures. A general rule of the US legal system is that if a given act is not prohibited, it is permissible. Inventing a new drug and deciding to take it is not illegal until the government says it is. Which is why you periodically see states and municipalities freaking out over whatever new substance the kids are using these days. Most recently it was spice, a kind of synthetic cannabis. Until that happens, new, unapproved drugs are basically fair game to create, possess, and consume.

But they aren’t legal to distribute, because that constitutes a commercial transaction over which the federal government has exerted pretty expansive jurisdiction. This power generally comes from the Commerce Clause, and the Supreme Court has been pretty generous in interpreting the Commerce Power where the regulation of drugs is concerned.  See, e.g., Gonzales v. Raich, 545 U.S. 1 (2005).  So while NZT is theoretically legal for Eddie to have and to use, the guy he got it from was definitely breaking the law.

We’ll keep these reviews coming as more interesting movies are released. A ton of great comic book movies are coming out this summer, including [amazon_link id=”B005H9B44A” target=”_blank” container=”” container_class=”” ]Thor[/amazon_link], [amazon_link id=”B004LWZW42″ target=”_blank” container=”” container_class=”” ]X-Men: First Class[/amazon_link], and [amazon_link id=”B005ZCXPP0″ target=”_blank” container=”” container_class=”” ]Captain America[/amazon_link], so stay tuned!