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Lex maniac

Investigating changes in American English vocabulary over the last 50 years

off-label

(late 1980’s | bureaucratese? businese? doctorese?)

The pharmaceutical industry has given us many new terms, but a lot of them are brand names. It’s not really clear to me on whose turf this expression arose, actually: the businessmen, the bureaucrats, the doctors, or a combination. But it couldn’t exist without the pharmaceutical industry. The “label” represents officially sanctioned conditions — symptoms, diseases, syndromes — for which the drug may be prescribed. In the U.S. (and many other countries), it depends on a regulatory body whose job it is to decide when a given drug has been fully tested and demonstrated reasonably safe and effective for a given condition. A doctor goes off-label when she deploys the medication against anything not on the approved list. The practice is quite common and also quite legal; unlike insurance executives, legislators have hesitated to take too much discretion away from physicians.

“Off-label” remains an adjective or spot adverb. It begins showing up in LexisNexis in the late eighties. The first notable examples appeared in the Australian press, but the expression probably arose here. The AIDS crisis ushered it into the language; that was before there was any approved treatment and doctors threw everything they could think of at this terrifying new disease, regardless of the stated purpose of the medication. (Nowadays we use the expression more in the context of cancer treatment, but any condition for which there is no generally recognized treatment will do.) It was pretty ordinary by 2000. Within the next ten years, “on-label” emerged to mean following the FDA-approved pathway, rather as “cis” has evolved so there will be an opposite of “trans.” Even today, the phrase, while capable of ironic shading or application in a different field (themselves off-label uses), still pretty much applies to medication, or medical devices.

Off-label drug use stirs up a very familiar, and ultimately intractable, debate, the same sort that swirls around “self-medicate.” Strictly limiting the uses for which any given drug may be prescribed is the safest course, saith the insurance industry, concerned above all with avoiding liability (off-liable?). In 1990, the FDA went after off-label marketing — advertising by pharmaceutical companies touting the benefits of non-FDA-approved uses. (Marketers now are free to engage in off-label promotion. Off-label prescribing — case-by-case by a physician — has never been discouraged by the FDA.) That was around the same time that insurance companies tried to stop paying for off-label prescriptions, because such uses were not officially sanctioned — though it doesn’t follow that they were unsafe. Doctors should have sufficient powers of observation to see when a medication consistently has a beneficial side effect and use the information to improve their treatment methods. It’s sound empirical knowledge, particularly when it comes from several independent sources. If we have to wait around for the FDA to approve it, lots more patients will die. Both sides are right at least part of the time; off-label uses are likely to involve more risk, but it is foolish to ignore repeatedly observed beneficial effects just because the FDA hasn’t done the work. There is no right answer, but in each unique case, one course is usually more likely to succeed than another.

Every generation comes up with its own “label” compound: “union label” served my parents’ generation and “record label” was the most likely instance in mine. Both are nouns; “off-label” has made a grammatical leap and may bring forth similar new labels in the future. Why not “under-label” or “low-label” or “label playing field”? Just don’t get it mixed up with “labile”; that would be “lip-label,” or libel.

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