Dem
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GOP
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Last week, we had an item on the Chevron decision, which may soon be overturned by the Supreme Court, creating potential chaos when it comes to the regulatory state. And over the weekend, we answered a question about what that might mean for FDA-approved drugs.
This, of course, is not our area of expertise. And over the weekend, we got several letters from readers who know the various dimensions of this issue far better than we do. Those letters were a little long for the Sunday mailbag, and it's an important issue, so we decided to run them today. To start, reader B.R. in Eatontown, NJ, who is a lawyer, on the overall legal picture:
I decided to write in about the current case before the Supreme Court challenging the broad authority given administrative agencies in the executive branch in drafting regulations. I felt that you were guilty of considerable overstatement about the potential impact of the Court's decision, if it reverses the current approach. That's not to say that there wouldn't be a major impact to certain aspects of the modern administrative state, but it will not go to the underlying principle that Congress can delegate various decisions to administrative agencies. Thus, it will NOT, to look at Saturday's question, mean that the Justice Department would no longer be able to schedule drugs.
While there are some who believe that the Constitution's allocation of legislative power to Congress means that Congress must write every single detail of what is allowed or prohibited into a statute itself, and that any delegation by Congress to another branch of the government of the power to decide what the law will be is improper, this is a very strict view of the separation of powers doctrine. However, the Supreme Court, in its early days under Chief Justice John Marshall, rejected this view, just as they rejected most restrictive interpretations of the Constitution. (He recognized, as he wrote in one of his more important decisions, that "We must never forget that it is a constitution we are expounding... intended to endure for ages to come, and consequently, to be adapted to the various crises of human affairs.") Instead, in 1825 the Court held that it was permissible for Congress to draft statutes that establish the "important principles" while delegating to another branch the ability to establish rules "to fill up the details." This holding has been reaffirmed in case after case over the years since, and is NOT under attack in the current case before the Court.
In order to understand what is involved in the current case, a little history is necessary. Even in the relatively early days of the United States, at least some of the enacted laws delegated to the executive branch a certain amount of discretion about how to put the laws into effect. With time, that became increasingly true. By the latter part of the 19th century, some such laws were written in pretty broad fashion. Thus, for instance, the Federal Trade Commission, created in 1914, was authorized to declare as improper "any unfair method of competition or unfair or deceptive act or practice in or affecting commerce." Clearly, that was a very broad delegation to the agency. Over the course of the 20th century, Congress created more and more administrative agencies, and in doing so delegated more and more authority to agencies to determine what conduct would be allowed or prohibited under standards that became very broad. As this happened, it became necessary for agencies to first interpret the statutes and decide what was meant, before they could adopt regulations implementing those interpretations.
From the earliest days of what became the administrative state, the laws had authorized the agencies to pursue actions in court to compel entities to follow their directives, on the one side, and for entities to challenge agency directives in court when entities believed directives were improper, whether because the statute itself was unconstitutional for some reason, or because the directives were inconsistent with the statute, or because they were not supported by evidence, or some other basis. The courts adopted a number of guidelines to define how they would approach these cases. One of the key guidelines arises from the fact that administrative agencies almost always focus on a single subject matter, typically a matter that is very technical in nature and highly specialized, and the members of the agency and, more importantly, its staff, develop expertise in that area that layperson judges could not hope to duplicate. Thus, the guideline provides that judges will give deference to the agencies on questions where the subject matter expertise of the agency was involved. For example, on questions that require understanding of the sciences involved in aviation, courts will defer to the FAA's determinations on those questions.
As the statutes became so broad in standards that agencies had to first interpret the statute before adopting regulations, the question arose whether the courts should afford the same sort of deference to agencies with regard to their interpretations of statutes. In 1984, the Supreme Court heard Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., to resolve the question. In its decision, SCOTUS announced what has become known as the Chevron rule, holding that courts should give that same deference to the statutory interpretations, at least when the statute is ambiguous. It is curious, especially considering what happened subsequently, that the Court went in this direction, given that by 1984, the Court had already become pretty conservative. The opinion was written by Justice Stevens (who by that time was becoming more liberal), and joined by Justices Brennan and Blackmun (who both were on the liberal side). But it was also joined by Chief Justice Burger and Justices White and Powell (none of whom would be confused with a liberal, especially on business-related issues). There were no dissents (Justices Marshall and Rehnquist, both due to illnesses, and O'Connor, due to a conflict of interest, all did not participate).
This decision has always been logically somewhat in conflict with one of the most fundamental principles in law, namely the principle that one of the primary functions of judges is to decide what the law is, including what statutes mean. This was one of the core pronouncements of Chief Justice Marshall in the first really important SCOTUS case, Marbury v. Madison, and has been firmly followed by the Court without the slightest waver in all its cases since. And it is not justifiable by the same rationale that is the basis for general judicial deference to administrative conclusions, namely that the agency has greater expertise than the judges. Statutes are not adopted by agencies, but rather by Congress, where members have no more or less expertise than judges. These, along with other less principled arguments, have meant that Chevron has always been seen as open to attack.
In the end, even if the current Court eliminates Chevron deference, it does not mean the end of the administrative state or even the end of the ability of agencies to adopt regulations. It simply means that regulations will be somewhat more subject to reversal by judges than before. In fact, it may mean that regulations will be somewhat less subject to modification every time a new president who comes from the other party is elected. Since it will be for the courts to say what the statute means, once a court does so, it will not be subject to change simply because of the change in party.
Personally, I think that SCOTUS's major questions doctrine, as recently established in the 2022 decision in West Virginia v. Environmental Protection Agency, is likely to be much more problematic than any change to the Chevron doctrine. It is a total wildcard, completely subject to the whims of judges as to what is important and what is not. The Chevron doctrine only goes to how statutes should be interpreted by agencies when adopting regulations, while the major questions doctrine completely eliminates the ability of agencies to adopt regulations on the topic.
Next up, reader R.K. in Indianapolis, IN, who is far more able than we are to speak to this weekend's question about scheduled substances:
I am a licensed and practicing pharmacist, and your response to D.K. in New York City has factual errors due to what I believe is a core misunderstanding of what it means for a drug to be scheduled.
There are three meaningful classifications of drugs for legal purposes: Over the Counter, Legend, and Scheduled. OTC drugs are available over the counter without a prescription. Legend drugs (like blood pressure meds) are available only with a prescription. They are considered unscheduled and are perfectly legal. Scheduled drugs are drugs that have additional restrictions placed on them due to the risk of addiction/abuse (showing ID when picking up, limits on how early you can get them, etc.).
Within scheduled drugs, there are 5 classes, I-V, with III-V not having any real legal distinction between them. Class I are drugs that have no medical use and are essentially illegal outside of research (LSD, meth, etc.). Class II are highly addictive and have serious restrictions on them in addition to being kept in a safe (Adderall, narcotic pain meds, etc.). III-V are moderately addictive with lesser restrictions (most sleeping meds, tramadol, testosterone, etc.).
Referencing the initial question about Chevron, the Controlled Substances Act gives the initial list of scheduled drugs (including the Class I/illegal drugs) and Congress has added things to it by law so those would stay the same. Some states also have set specific schedules for drugs outside of federal law (Gabapentin is an example there). That would also remain unchanged as we follow the more strict laws. Anything else would depend on the new drug approval process, which is unknowable at this point, but would likely include a drug's classification and schedule as part of the approval process.
Pharmacists almost to a fault are cautious types, so we would likely continue as previously normal under a post-Chevron world until we received direct communication and instructions from some official entity, like the DEA/FDA, board or pharmacy, or our employers.
And finally, reader J.C. in Ulaanbaatar, Mongolia, on a potential consequence of Chevron's demise, if federal departments' autonomy is reduced:
I read with interest the item about the Chevron case. I was, very briefly, a JAFO—Just Another Observer—for National Marine Fisheries Service, a department of NOAA, which is itself a department of the Department of Commerce. Turns out that being out at sea for 2 months in the Bering surrounded by people who hate your guts because you represent the Fed, in 30' seas and 24-hour shifts, is not as much fun as it sounds, so I quit.
To my mind, these cases represent another grave threat—the collapse of all of our fisheries. To back up what you were saying about experts, managing fisheries is very complicated. You have to gather data on the local population of a species this year, and how it's changed in past years; what the populations of its predators and prey are; what the climate is like; what the weather is like; what the impact of global warming is; how the nanoplankton like marine bacteria and viruses might impact things; what the impact of fishing has been in the past; recruitment levels of that species (how many eggs become swimming adults); how many boats are out there this year; and what the palate trends of America's plates are. And then you have to predict what will happen next year with all of that. And then do that for every species in the area. In other words, it takes experts—not members of Congress. I had a whole course in undergrad to just introduce the topic. (I picked the Grey Whale fishery. My paper recommended that they had reached sustainable levels once again.)
This is what observers do—they do 24 hour randomized shifts to gather data on fish count and otoliths (ear bones that determine age) so that the actual scientists can analyze everything and make sure there is a fishery next year. That TV show Deadliest Catch is literally about that—the King Crab fishery is so depleted they have only two days to go out, even if there's a storm—and some years there's no quota allowed at all. If we don't manage it, we lose all our fish. Consider, no more seafood on America's plates, and no more marine ecosystem in America's waters. (The former is the American perspective as part of the Department of Commerce; the latter is the Canadian way—their observers are part of their department of the environment.)
The threat is real. We've seen fishery collapses before, such as the Grand Banks. Fish is the last wild food humans, and Americans, eat. Yes, fishermen don't like the "Fish Cops" that they have to pay for, but without them—within a few years they wouldn't have a job. And extinction is forever. And once the marine ecosystem collapses, well, when they made the apocalyptic film Soylent Green a half century ago, they didn't realize that half of our oxygen comes from the oceans.
Thanks to the three of you for sharing your expertise! (Z)