Post-Chevron in Practice: Drug Approval and Mixed Economic-Political Metaphors
The Loper Bright cases involved determining the obligation of who pays for fishing boat monitors, which are statutorily required to assure fishing sustainability. (The pay issue was not statutorily addressed). This matter is not technical or scientific, but rather one that weighs business profits to the plaintiffs (who call themselves “victims”) against piscatory preservation. This is surely a determination within the ken of the courts or better addressed by a politically inclined Congress, and one is quite comfortable “adjudicating” the primacy of cash versus conservation.
By contrast, the prime function of the CDC and FDA is to protect health and safety. To do so, they tap a vast array of technical and scientific resources, including a highly trained professional corps. Their decisions, for example, whether to regulate a product as a drug or food supplement, greatly impact both costs and benefits to a manufacturer – as well as consumer safety. As I discussed with the Pacqui-problem, some marketable products can be dangerous, and some issues are legally vexing. This dual question implicates not only health but economics and politics. Which will win out by the newly empowered post-Chevron judiciary remains to be seen. But, FDA Commissioner Califf has expressed concern not only with disagreements on individual agency determinations but also with judicial interference in the drug approval system itself.
No Dunning Kruger for the Courts
“The Dunning-Kruger effect is a cognitive bias in which people wrongly overestimate their knowledge or ability in a specific area.”
While courts may be well-equipped to weigh bucks versus biological sustainability, assessing product safety, efficacy, and costs is outside the scope of their knowledge. (1) Hopefully, going forward, courts will adhere to rulings in an analogous case and recognize the agency’s substantive expertise. As Justice Elena Kagan wrote in Kisor v. Wilkie (which is still good law)“Agencies (unlike courts) have "unique expertise," often of a scientific or technical nature, relevant to applying a regulation "to complex or changing circumstances…. That preference may be strongest when the interpretive issue arises in the context of a "complex and highly technical regulatory program….”
While Kisor relates to agency rule-making rather than statutory interpretation, the concerns of judicial hubris trampling on scientific expertise are identical. Justice Stephen Breyer agreed, noting that “judges should defer to agency expertise regarding their own regulations because agency officials often know more about technical policy details than judges.” [emphasis added]
Fish-Oil and FDA Product Classification
Here’s a concrete scenario of dangers that might arise from failing to defer to agency assessment:
“A large [clinical] trial found that the drug decreases the risk of heart attack, stroke, and death from cardiac causes by 26% when compared with a placebo.” -Harvard Healthy Heart
The FDA recently approved two new drug applications for fish-oil-based products containing omega-3 fatty acids to ameliorate cardiac conditions. These omega-3 fatty acids are associated with reduced inflammation, which in turn supposedly reduces cardiac risks. They also have been approved to lower triglyceride levels, so manufacturers can claim this as an additional health benefit.
Numerous cheaper, fish-oil-based diet- supplements are also on the market, although they cannot claim the same efficacy. However, supplement manufacturers aren’t required to expend vast sums of money to conduct clinical trials to support claims that their product might “diagnose, cure, mitigate, treat or prevent a disease.” Supplement manufacturers can only claim to reduce risk.
While dietary supplements are cheaper than drugs, the quantity, quality (purity), product consistency, and freshness of their omega-3 fatty acids are not regulated. Nor does the FDA monitor the supplement industry to ensure each vitamin or mineral actually contains what it says on the label or routinely tests for contamination, be it by bacteria, heavy metals, pesticides, or plastic residues. However, FDA drug approval certifies product safety and efficacy and ensures monitoring for post-manufacture degradation (as seen in the Zantac cases). No similar monitoring exists for dietary supplements (although private labs can and do assess these parameters and provide some assurances of product “standards”).
While manufacturers weigh their financial costs and benefits, the health risks and benefits accrue to the consumer. The FDA is charged with safeguarding the consumer's best interests, but that is not necessarily the court's role. Other than to somehow divine the statutory intent, its role vis a vis consumer is unclear. And even with divine and correct interpretation, that intent sheds little light on specific product-related risks and benefits.
A product may be classified as a supplement, and a consumer might choose to pay the cheaper cost of the supplement and “hope for the best.” That may not be a problem for the otherwise healthy consumer, who is not dependent on a product to cure or treat or to rely on a product’s safety. But what if it isn’t?
If new information regarding risks accrues post-drug approval, the FDA can order updated warnings and notify physicians directly of newly found dangers. For supplements, communications are limited and delayed.
A recent study reported that folks in good cardiovascular health who consume fish oil supplements regularly might have a 5% increased risk of first-time stroke and a 13% increased risk of atrial fibrillation [2]. Such studies might induce the FDA to classify some dietary supplements as drugs or alter required warnings on existing drugs. However, any FDA decision would have both economic and health ramifications.
So, does anyone really want courts involved in science-centered agency decisions? Likely not if they involve purely scientific/technical decisions. Hopefully, future courts will consider invading the scientific, technical province of agencies “judiciously.”
[1] Unless, as many judges do, they hire law clerks with PhDs in science or have had sufficient experience under the tutelage of judges who were not science-averse
[2] Atrial fibrillation is a type of arrhythmia or irregular heartbeat that people often describe as a flutter or pounding in their chests.
