George A. Burdock, PhD [1]
President, Burdock Group
This June, the Supreme Court overturned its own original 1984 Chevron Deference decision.[2] The 1984 decision had at least two very far-reaching provisions: (1) according to the Administrative Procedures Act, an appropriate Executive Agency (i.e., a regulatory agency), is mandated to implement a law through rule making (i.e., promulgating a regulation) however, Chevron Deference allowed the regulatory agency to do so by allowing considerable latitude in interpreting the often vague framework provided in a law and; just as important, (2) if the rule (regulation) was challenged in court, the district (or lowest) federal court must defer to the regulatory agency’s interpretation of the law, unless the interpretation was obviously different from what was intended by Congress.
The first provision resulted in, according to Chief Justice Roberts [3]: “[An] unwarranted instability in the law, leaving those attempting to plan around agency action in an eternal fog of uncertainty.” The Chief Justice disposed of the second provision with the statement, “Courts must exercise their independent judgement in deciding whether an agency has acted within its statutory authority,” therefore re-asserting the rightful role of the court.
In response to the Supreme Court’s decision, one suggested remedy is for Congress to write laws with less statutory ambiguity and more granularity, leaving little room for creativity (positive or negative) by the implementing regulatory agency. However, this gets us back to why laws are vague in the first place; that is because (1) Congress does not have the technical expertise or sophistication in a particular area to provide very specific instruction and to be more specific would likely only result in even more laws written by lobbyists and; (2) laws are often purposely left vague to achieve consensus among legislators in order to gain enough votes for passage. Therefore, what is likely to happen is that Congress will write the same vague laws but include a work-around statement allowing the implementing agency to confer more specificity (i.e. delegating “discretionary authority to the agency”).[4]
So, we are back to where we started, except for the deference part of this conundrum.
The significance of the deference part becomes immediately clear in Justice Kagan’s dissent [5] where she laments that, who now will make technical decisions for the court? The Justice’s complaint is valid because pre-law curricula in most schools do not require any science courses and the minimal requirements by a school for a bachelor’s degree are usually for a year of freshman biology, botany or entry level math and with this in mind, the science questions on the LSAT [6] are not about how which nucleic acid bases are used in DNA vs. RNA or the derivation of Avogadro’s [7] number, but a reading comprehension test of a paragraph describing a scientific finding. There is no test on how to evaluate a scientific or technical finding. Therefore, where a dispute over a regulation hinges on a highly technical or scientific matter, a jurist would be out of his/her depth in assessing the worth of the facts before him/her.
Because of this acknowledged lack of scientific acumen by jurists, Chevron deference provided a handy crutch by deferring all questions scientific or technical to the regulatory agency and if the agency’s response seemed reasonable to the court, the petitioner was out of luck – so much for due process. This deference to the regulatory agency saved the court’s time and effort by first qualifying and then hearing the expert witnesses. Although testimony by regulators would be vital to a scientifically naïve judge, as pointed out in the Justice’s dissent; however, at least some of the Justice’s examples tell another story; that is, did the regulatory agency’s decision actually mean what it said and did the decision have a legitimate basis? For example:
Under the Public Health Service Act, the Food and Drug Administration (FDA) regulates ''biological product[s]," including "protein[s]." 42 U. S. C. §262(i)(l). When does an alpha amino acid polymer qualify as such a "protein"? Must it have a specific, defined sequence of amino acids? See Teva Pharmaceuticals USA, Inc. v. FDA, 514 F. Supp. 3d 66, 79--80, 93-106 (DC 2020).
The above example is illustrative of the naivete of the Justice; that is, the question is not if an alpha-amino acid polymer is a protein or not, but a reading of the statute reveals the relevant question to be, is the polymer identical or interchangeable with the biological product to which it is purported to be biosimilar? Many proteins, natural or synthetic, can have alpha- or beta-configurations, but the question is actually if the polymer is functionally interchangeable with the reference product? The relevant questions would be (1) what “biosimilarity” was intended and (2) were the tests or methodology used to demonstrate biosimilarity scientifically adequate and sound? The answer to the first question would be in the biosimilar application, but in responding to the second question, could the regulator demonstrate his expertise to the extent he/she could comment on whether the methodology was scientifically adequate and sound or, could such a judgement only be made by an expert in this specific area of science?
Justice Kagan also cited a dilemma in sorting out one population of gray squirrels from another:
Under the Endangered Species Act, the Fish and Wildlife Service must designate endangered "vertebrate fish or wildlife" species, including "distinct population segment[s]" of those species. 16 U. S. C. §1532(16); see § 1533. What makes one population segment "distinct" from another? Must the Service treat the Washington State population of western gray squirrels as "distinct" because it is geographically separated from other western gray squirrels? Or can the Service take into account that the genetic makeup of the Washington population does not differ markedly from the rest? See Northwest Ecosystem Alliance v. United States Fish and Wildlife Serv., 475 F. 3d 1136, 1140-1145, 1149 (CA9 2007).
Again, this is a distinction that could be made by a regulator or an expert witness, if the individual could demonstrate the squirrel population was distinct from others based on scientifically recognized criteria, but the individual would also have to demonstrate that his/her peer-group recognized his/her ability to identify, understand and verify the distinguishing criteria.
Therefore, would regulators, in general, qualify as experts? The Federal Rules of Evidence, Rule702 (as amended, 2023) describes the basics required for an expert witness:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert's opinion reflects a reliable application of the principles and metho to the facts of the case.
While a regulator would ostensibly be qualified according to Rule 702, the issue(s) in question may be for example, in the case of foods, food ingredients or supplements, based on inflexion points on very specific scientific techniques and methodologies or on a broader assumption based on familiarity with entire classes of substances, but not on policy. With this in mind, according to some experienced legal practitioners [8], cross examination could be withering. The first route of attack would likely be on the individual’s experience; that regulators have no discoverable or documentable track record of the types of specifically relevant projects or methodology or procedures in question or broad classes of substances on which the person has worked, or the type of work performed, or even if the work was administrative or scientific. Second, because publication represents the currency of credibility of any expert and, as a rule, a regulator even with any tenure has few scientific publications supporting his/her credibility and probably none in the possibly very narrow subject matter presented, simply because of the nature of the job. Third, without any evidence of hands-on (laboratory) experience or scientific credibility achieved through publication, regulators could only address a Skidmore-type deference [9] (e.g., “because the agency has always done it that way”), a decision which, unknown to the regulator, may have been tainted by some ex parte influences such as need, benefit or “other relevant factors”.[10]
If not regulators, who would qualify as experts? Addressing those qualifications for toxicologists, the individual would require at least a competition-based qualification such as certification by the American Board of Toxicology and for an individual with greater tenure, peer group recognition such as a Fellow of the Academy of Toxicological Sciences. The type and extent of publications would be critical, but the specific journal would not be as critical as described by Haak (2014) in her description of the publications regarding Bendectin in the Daubert v. Merrell Dow Pharmaceuticals [11] case; that is, not all manuscripts can be published in the journal Nature and as learned from the recent Covid-19 scandals, some valid dissenting publications could be suppressed. Rightly or wrongly, genuine participation in the authorship of a scientific publication is often measured in the order of authors; that is, some criteria eliminate much credibility to any author beyond the third author of a manuscript. Also, the somewhat intangible concept of peer-recognition of expertise might be quantified by the number of invited presentations. However, expertise in a particular science or technology so advanced or specialized may not have any peers having coalesced around a particular school of thought and in this case, the expert would have to speak with a high degree of certainty of his/her own opinion based on his/her own investigations, rather than speaking for the scientific community.
When first instituted, Chevron deference benefited a scientifically deficient judiciary, but had the unintended consequences of leaving final decisions to regulators whose pre-occupation is finding fault over finding solutions. With the death of Chevron deference and likely Auer and Skidmore deferences, due process has been restored and diversity of thought injected into the process of regulatory approval.
Because court battles are both prolonged and expensive, the overbearing consideration for any company is to get it right the first time. We at Burdock Group feel there is so much subjectivity in the approval process, that not only should all the factual evidence be presented in an unbiased manner, it needs to be presented persuasively – no data dumps or turn-offs with extraneous information or the opposite, logic gaps or sketchy evidence hoping the agency will fill in the gaps and cut you some slack. The scientists at Burdock Group, individually and as a whole, meet the publication “currency of credibility” standard, in addition to practical laboratory experience, an understanding of the nuances of regulatory drivers and inflexion points that can make a project a success or an also-ran. We have a history of success in our presentations and submissions to the agencies because of our respect for the information required and the regulators who task us to review it. Let us help you with your next project and we will optimize your probability of success.
[1] The author is a toxicologist with 35+ years of experience but is not a lawyer or able to provide legal advice.
[2] Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 468 U.S. 837 (1984).
[3] Chief Justice John Roberts writing for the majority in Loper Bright Enterprises v. Raimondo, 603 U.S. ___.
[4] Ibid.
[5] Justice Kagan writing for the minority in Loper Bright Enterprises v. Raimondo, 603 U.S. ___.
[6] LSAT = Law School Admissions Test
[7] Ironically, Amadeo Avogadro (1776-1856) was a lawyer who eventually became the first professor of physics in Italy.
[8] Haak, S. (2014). Evidence Matters: Science, Proof, and Truth in the Law. Cambridge University Press. 416 pp.; Imwinkelried, EM (2022). The Methods of Attacking Scientific Evidence. Matthew Bender and Company. 439 pp.
[9] Unlike Chevron deference, Skidmore deference did not require courts to defer to the EA.
[10] Such as decision making for color additives (21CFR721(b)(5)(A) wherein the Commissioner is mandated to consider “other relevant factors” bearing on final approval of the additive.
[11] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)
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