Is There Any Point in Pursuing Correctness? — Beyond Correctness, Toward Reaching

For the regulatory reviewer, "correctness" is the foundation of the work. The Pharmaceutical and Medical Device Act, the materials production guidelines, evidence, risk labelling — each is a criterion for judging whether something is "correct." But as we continue in this work for a long time, we frequently come to a halt at a certain moment. "I had the correctness in hand. But it did not reach." As the starting point of this series, let us face that question first. To what extent does the pursuit of correctness have meaning? William James, Pyrrho, Confucius, Hume, Mill, Foucault, Rosenberg, and Wittgenstein — eight traditions answer the same question in different words.

01The Curse of "Correct Review"

"I am correct"; "my finding is sound" — there are moments in regulatory review when we feel this. And the "correctness" we feel in that moment is, in most cases, genuinely correct. Legally, in regulation, and in evidence, the judgement is sound. And yet it does not reach the other. Rather the other's defence stiffens and the relationship strains. Why?

The hypothesis this series treats is this: "correctness" is the necessary condition of the work, not the sufficient one. Setting correctness as the ground, unless one builds on top of it the separate quality of reaching, communication does not stand. This volume first re-examines that very ground of correctness. Is "correctness," as we believe it, as self-evident and as firm as we think?

02William James — Correctness Is Situational

The American pragmatist philosopher William James (1842–1910), in Pragmatism (1907), redefined truth not as a fixed property but as a working in context.

"Truth is the power our ideas have to work well within experience. Truth is not a static property but a relation that arises when ideas meet the world." — paraphrase of William James, Pragmatism (1907)

What James points out is the fact that even the same proposition, in a different context, has a different meaning as truth. "This description may mislead" — abstractly, this is always correct. But depending on the scene, the addressee, and the timing in which it is said, the force with which that correctness functions changes greatly. In the field of regulatory review, the same correct finding produces deep learning in one situation and breaks the relationship in another. What makes the difference is not the proposition itself but the relation of proposition to context.

03Pyrrho and "Suspension of Judgement" — The Prudence of Holding the Claim of Correctness in Abeyance

The ancient Greek philosopher Pyrrho of Elis (c. 360 – c. 270 BCE) is known as the founder of thoroughgoing scepticism. The central concept he taught is epoché (the suspension of judgement). Before declaring at once "this is correct" about any proposition, hold the judgement in abeyance — this was the starting point of Pyrrhonism.

"On every matter, one can find a counter-matter. Therefore the prudent course is to suspend judgement (epoché) and keep the mind at rest (ataraxia)." — paraphrase of Sextus Empiricus, Outlines of Pyrrhonism (2nd c. CE)

Epoché is not agnosticism. Rather than asserting "correctness does not exist," it counsels "do not rush correctness." When this is applied in the field of regulatory review, something interesting happens. Even a material that at first sight clearly looks like "an error," when judgement is once held back, may surface another interpretation, another context, another intention. Slowing down by one beat the habit of rushing to judgement — this alone changes the quality of communication.

04Confucius — "Harmony Without Sameness"

From the Eastern lineage, one of the most important propositions. The words of Confucius (551–479 BCE) transmitted in the Analects, "Zilu":

The Master said: The gentleman harmonises without making things the same; the petty man makes things the same without harmonising.
— Analects, "Zilu" (君子和而不同、小人同而不和)

This proposition of Confucius has often been misread. Read merely as "the gentleman values harmony" — one misses the essence. What is important is the distinction between "harmony" (和) and "sameness" (同). "Harmony" is the concord that contains difference; "sameness" is the agreement that has erased difference. To seek the agreement that erases difference (sameness) is the way of the petty. To seek concord while respecting difference is the way of the gentleman.

In the field of regulatory review, when one makes it the aim to make the other's judgement "the same" as one's own, one frequently arrives at confrontation or appeasement. Aiming at "harmony" — concord toward a common end (the benefit of the patient, regulatory compliance) while acknowledging difference — changes the quality of dialogue. To pursue correctness is not to make the other "the same" as oneself, but to arrive at a "harmony" that contains difference — this is the direction Confucius points to.

05Hume's is/ought Gap — One Cannot Derive Correctness from Fact

The Scottish philosopher David Hume (1711–1776), in A Treatise of Human Nature (1739), put forward one of the core propositions of modern philosophy: one cannot derive a normative claim ("ought") from a factual claim ("is").

"In every system of morality I have hitherto met with, the author proceeds for some time in the ordinary way of reasoning, and then, suddenly, I find that the propositions have all switched from 'is' to 'ought' — and this switch is never justified." — paraphrase of David Hume, A Treatise of Human Nature (1739)

Let us apply Hume's implication to regulatory review. The transition from "this description violates the article of the Pharmaceutical Act" (fact) to "therefore it should be corrected" (norm) is not logically self-evident. The interpretation of the article (fact), the soundness of the correction (norm), the choice of correction method — all are mediated by human judgement and value. The word "correct" is often used while leaving the boundary between fact and norm blurred. Noticing this makes it easier to see how far one's claim of "correctness" is supported by fact and from where it has crossed into the choice of norm.

06Mill's On Liberty — Tolerance of Dissent Hones Correctness

The English philosopher John Stuart Mill (1806–1873), in On Liberty (1859), argued lucidly the cost of suppressing dissent.

"The silencing of any discussion is a robbing of the human race. If the silenced opinion is true, humanity loses the opportunity to arrive at truth. If it is wrong, humanity loses the opportunity for truth to be more clearly perceived by collision with error." — paraphrase of J. S. Mill, On Liberty (1859), Chapter 2

What Mill's proposition shows is that correctness can hold its outline only against the contrast with dissent. "I am correct, therefore I need not listen to the other's view" — this posture, though it looks firm, is the path that most impoverishes one's own correctness. Conversely, when one listens seriously to the other's view, tests one's own judgement against it, and still judges correctly, that correctness for the first time becomes firm. In the field of regulatory review, the habit of dismissing the other's rebuttal as "excuse" is the habit that fails to hone one's own correctness.

07Foucault — Correctness Is Not Unrelated to Power

The French philosopher Michel Foucault (1926–1984), through Discipline and Punish (1975) and The Archaeology of Knowledge (1969), developed the proposition that knowledge and power are inseparable.

"Truth is not outside power. Each society has its 'regime of truth' — the mechanism that decides which discourse it accepts as truth, which it excludes, and who has the authority to speak the truth." — paraphrase of Foucault, lecture "Knowledge, Power, Body" (1976)

Foucault's proposition often sounds provocative. Read all the way to "correctness is merely a tool of power," one falls into nihilism. What he points out is a more measured fact. "What is taken to be correct" is always woven with social structure and power relations. The reviewer's "correctness" also stands on industry practice, the authority's judgement, internal politics, and expert certification — these structures. To be conscious of this is not to deny one's correctness but to be conscious of the ground on which one's correctness stands. Correctness conscious of its ground is less apt to become self-righteousness.

08Rosenberg NVC — Empathy Comes Before Correctness

The American psychologist Marshall B. Rosenberg (1934–2015) developed Nonviolent Communication (NVC) from the 1960s onward. What he arrived at, through years of mediating interpersonal conflict, was the clinical fact that the assertion of correctness almost always closes communication.

"If you wish to share something with the other, first listen to the other's feelings and needs. 'You are wrong,' however correct, is a sentence that closes the other's heart. Correctness uttered after the heart has been closed reaches no one." — paraphrase of Marshall B. Rosenberg, Nonviolent Communication (1999)

At the core of NVC is grasping the other's observations, feelings, needs, and requests — four layers — without inserting evaluation or judgement. For the reviewer, this is a hard challenge — because our work is to judge. But what Rosenberg points to is the order: before judging, first grasp empathically. Correctness that has passed through empathy becomes correctness that reaches. Correctness that has skipped empathy disappears into the air, however correct. Before the pursuit of correctness, there is the work of empathy. — this is the core proposition of NVC.

09Wittgenstein's Silence — The Recognition of the Region That Cannot Be Spoken

The Austrian philosopher Ludwig Wittgenstein (1889–1951), in the famous final proposition of Tractatus Logico-Philosophicus (1921), wrote:

Whereof one cannot speak, thereof one must be silent.
— Wovon man nicht sprechen kann, darüber muss man schweigen. (Tractatus, Proposition 7)

What Wittgenstein points to is not mysticism. It is an epistemological proposition: the region that can be spoken of with precision in language has a limit, and forcing what is outside that limit into language distorts correctness itself. In the field of regulatory review too, not every judgement can be fully justified in words. The more one tries to verbalise "why this is a problem," the more some truly important thing leaks from the words. At that moment, instead of piling on more words, choosing silence is also a way of correctness. We return to this theme in the final volume of the series (Vol. 10).

10Four Practices Beyond "Correctness"

To bring the same place to which the eight traditions pointed down into daily practice, four practices are set here.

The pursuit of correctness does have meaning. Without it, the work of regulatory review does not stand. But the pursuit of correctness alone does not make communication stand. James, Pyrrho, Confucius, Hume, Mill, Foucault, Rosenberg, Wittgenstein — eight traditions pointed, in different words, to the same place. Correctness is necessary, not sufficient. Setting correctness as the foundation, build on top of it the separate quality of "reaching." This is the practice this series will pursue throughout.

"I am correct" — when you feel this, ask again. "I am correct. Then how shall I convey it?" The second half of the question is the true entry of communication.