There is a particular kind of advertisement that an American sees so often it has become invisible, and that almost no visitor can watch without staring.
A person is shown doing something pleasant in good weather. A condition is named. A medicine is named. And then, over the final third, a calm voice reads a list of possible side effects at a speed that is clearly calibrated to satisfy a requirement rather than to inform anybody, while the pictures continue showing the pleasant weather.
Americans have watched this for a quarter of a century and regard it as part of the furniture of television. In most of the world it would be illegal, and the reason it is legal in the United States is a specific regulatory decision taken in the nineteen-nineties that most Americans have never heard of.
Two Countries
The practice is called direct-to-consumer advertising of prescription medicines, and the striking fact about it is how isolated it is.
Prescription medicines are, by definition, products a consumer cannot buy by choosing them. A doctor must decide. The near-universal regulatory position therefore is that advertising them to the public makes no sense and carries obvious risks, so manufacturers may promote them to prescribers and must not promote them to patients.
Two countries have gone the other way. The United States permits broadcast and print advertising of prescription medicines to the general public, subject to disclosure requirements. New Zealand permits it too. That is essentially the list.
Every other developed country prohibits it or restricts it so tightly that nothing resembling an American television drug advertisement could run.
Like our content? Follow us for more.
How America Got There
The American position did not arrive through a single decision to allow it. It arrived through a problem with television.
Advertising of prescription medicines to the public was not actually prohibited in the United States in the way it is elsewhere. It was permitted in principle but governed by a requirement that an advertisement naming both a product and what it treats must also present a fair balance of risk information – in practice, the substantial detail that appears in the small print of a magazine advertisement.
In print that is workable. You can put a page of risk information behind the advertisement and satisfy the requirement. On television you cannot, because reading several minutes of contraindications aloud is not an advertisement anybody would buy.
So for years American television carried only two kinds of drug advertisement. One named the product without saying what it was for. The other described a condition and told viewers to ask their doctor, without naming any product. Both are strange to watch and both were obvious workarounds.
The change came in the late nineteen-nineties, when the American regulator issued guidance clarifying that a broadcast advertisement could satisfy the requirement by stating the major risks and directing viewers to adequate information elsewhere – a magazine advertisement, a toll-free number, a website, a pharmacist.
That is the whole mechanism. The rule was not repealed. A route to compliance was opened that television could actually use, and the modern American drug advertisement is the shape that route produced.
Which Is Why the Advertisements Look the Way They Do
Almost every odd feature of an American drug advertisement is a direct consequence of that compliance route, which is why they all look the same.
The rapid list of side effects exists because the major risks must be stated. The speed exists because airtime is expensive and the list is long. The pleasant imagery continuing underneath exists because nothing requires the pictures to match the words, and a manufacturer would obviously rather you watched the dog.
The instruction to ask your doctor exists because the manufacturer cannot sell you anything directly and the prescriber is the actual decision-maker. The website and telephone number exist because that is the adequate-provision route being used. And the strange construction where a condition is described in unusually broad terms exists because an advertisement reaches everybody while the medicine suits very few of them.
None of this is accidental and none of it is aesthetic. The format is a regulatory artefact.
The Case For It
The arguments in favour are real and are not only made by manufacturers, and they deserve stating properly.
Awareness is the strongest. A substantial number of treatable conditions go undiagnosed because the person who has them does not know the condition exists, does not know it is treatable, or does not regard what they are experiencing as a medical matter at all. An advertisement that causes somebody to raise something with a doctor they would otherwise never have mentioned has done something useful, and this effect is claimed particularly for conditions people are reluctant to discuss.
Patient participation is the second. A system in which treatment decisions are made entirely by prescribers and the patient is told nothing has its own failure modes, and information reaching patients directly supports the kind of consultation where the patient arrives with questions.
And the disclosure argument is worth taking seriously. American drug advertising, whatever else it is, obliges a manufacturer to state the major risks of its product to the general public, repeatedly, at its own expense. In countries where promotion happens only to prescribers, no equivalent public statement occurs.
The Case Against It
The objections are also substantial and they are the reason the rest of the world has not followed.
The central one is that the advertisement is addressed to the person who cannot evaluate it. A prescriber has training, access to the underlying evidence and a professional obligation. A viewer has thirty seconds of pleasant imagery and a fast list, and is being asked to form a preference about a product whose risk profile they have no means of assessing.
The second is pressure on the consultation. A patient who arrives naming a product changes the dynamic of the appointment, and a prescriber who declines must spend consultation time explaining why, which is time they may not have. Whether that pressure changes prescribing is exactly the question the research has been arguing about for twenty years.
The third is the economics. Advertising is concentrated on newer products still under patent, because those are the ones with margin to spend on it – which means promotional attention does not track clinical importance, and may run against it where an older and cheaper option would do.
And the fourth is simply the volume. The quantity of pharmaceutical advertising on American television is large enough to be a significant share of what a viewer sees in an evening, which is a strange thing for any country’s broadcasting to consist of.
What New Zealand Did
The other permitting country is worth a paragraph, because its position has not been settled either.
New Zealand arrived at the same place by a different route and has reviewed the question repeatedly. Its medical profession has pushed for prohibition, government reviews have examined it more than once, and the practice has survived each time without ever acquiring a firm consensus behind it.
That is the honest state of the international picture. It is not that two countries considered the question carefully and came to a different conclusion from everybody else. It is that two countries ended up permitting it, largely for procedural reasons, and have never quite summoned the political energy to reverse it.
The Part of the Format That Is Changing
The one element of the American advertisement that has shifted recently is the risk recitation itself, and the shift is instructive.
The original compliance route allowed a manufacturer to state major risks on air and point elsewhere for the rest. In practice that produced the gabbled list, delivered fast and under music, which satisfied the letter of the requirement while being close to unusable as information. That gap between compliance and comprehension was obvious to everybody watching, including the regulator, and it attracted attention for years.
The response has been to tighten how the information must be presented rather than to reduce what must be said: requirements aimed at ensuring the risk statement is actually audible and intelligible, delivered in plain language, and not undercut by competing audio or visuals running at the same time.
It is a modest change and it does not alter the fundamental arrangement, but it is worth noticing because it identifies the real criticism of the format. The complaint was never that the risks were hidden. They were stated, out loud, every time. The complaint was that stating them that way was a performance of disclosure rather than disclosure, and the regulatory response has been to insist on the difference.
The Honest Summary
Direct-to-consumer advertising of prescription medicines is broadly permitted in two countries, the United States and New Zealand, and prohibited or effectively prohibited everywhere else.
America did not decide to allow it so much as discover a way to make it work on television. The underlying requirement – that an advertisement naming a product and its use must present a fair balance of risk – had always made broadcast advertising impractical, which is why American television once carried drug advertisements that either named no product or named no condition. Regulatory guidance in the late nineteen-nineties opened a compliance route in which major risks are stated on air and fuller information is provided elsewhere, and the modern format followed immediately.
Every strange feature of those advertisements – the gabbled risks, the unrelated pleasant pictures, the instruction to ask your doctor, the website – is a consequence of that route rather than a creative choice.
The arguments on both sides are genuine. It does cause people to raise things with doctors they would not otherwise raise, and it does oblige manufacturers to state risks publicly. It also addresses the one party who cannot evaluate the claim, concentrates on the newest and most expensive products, and puts a prescriber in the position of talking a patient out of something.
And the rest of the world has looked at the same arguments and declined.
Like our content? Follow us for more.
