Apr 15, 2019 10:53
5 yrs ago
4 viewers *
English term

Contraindications disclaimer?

English Medical Medical: Pharmaceuticals Advertising for medical drugs
What do you call that part of a commercial for a pharmaceutical product where, at the very end, a voice-over speaker lists really fast all the main contraindications of a product?
I assume there is a very specific term for that, but I couldn't find it.
"Contraindications disclaimer" is just my guess, but I couldn't find much evidence to back it up.
Thanks

Discussion

Claudia Letizia (asker) Apr 18, 2019:
Thanks to everybody Hi guys,
This conversation has been very informative and has helped me greatly in finding the solution that I have decided is best for my text. Your solutions are all excellent and I have a hard time pointing to one person who deserves the Kudoz points. That's why I am going to leave that to peer decision.
Thanks a lot!

For those of you who are curious, this is my sentence: "Sadly, in broadcast ads the presentation of risk information which is mandatory by law is packaged so as to sound as negligible as possible for the audience"
Oliver Simões Apr 16, 2019:
I meant to say that "major statement" will not be understood unless you are a marketing expert who's familiar with its meaning. It's a jargon. The average person will not understand it unless meaning is clarified.
Charles Davis Apr 16, 2019:
Who is going to read this? Maybe not the average Joe?
Oliver Simões Apr 16, 2019:
I agree with Amel. "Major statement' is meaningless for the average Joe, it means nothing. Any English-language viewer can understand "disclaimer", "disclosure", or "warning". It's obvious that there are differences in how drug ads are presented to the public in each country. Or even if they are presented in the first place. I think nobody would dispute that. On the other hand, it's clear that the Asker showed her preference for US English. She seems to have a very clear idea of what she's talking about. In my opinion, the translation should revolve around her specific context/explanation.
Björn Vrooman Apr 16, 2019:
That's why I'd be cautious about phrases that could be used to describe the same thing in any other industry: There are less than a handful of countries where DTC is allowed. The warning messages in commercials broadcast in Germany, Spain or elsewhere are not the same. They don't list "really fast all the main contraindications of a product," as Claudia put it.

I can ask again (since we are a DE-US household), but AFAIK, OTC drugs don't have that kind of warning in the US (and I couldn't find an example on YouTube either).

While I'm not opposed to finding something that is easier to wrap your head around, I'm wary of overly general descriptions that don't take account of the very specific, say, cultural context.

As an example, a German who has never seen a US commercial that includes a major statement will most likely think of "Bei Risiken und Nebenwirkungen fragen Sie Ihren Arzt oder Apotheker" if you use warning or disclaimer. But that isn't even close.

It seems that one thing Phil and I can agree on is that you could add something. I wouldn't use "high-speed" (as said, imagine you haven't seen one before) but put the focus on how long or detailed it is.

Best wishes
Björn Vrooman Apr 16, 2019:
Hello Charles, hello Amel First off, thank you both.

Now I no longer have to wonder why I don't find a UK equivalent--'cause there is none!

I do think, Charles, that this part of your second post is pretty important:
"...they always end with a very rapid spoken and on-screen message saying 'read the leaflet and consult your pharmacist.'"

I'll get to that in a minute.

Also, Amel, I don't think we disagree. I did assume Claudia wanted to know what the FDA uses, but if not, of course, there are other options.

My thinking was that

a) once you know the FDA term, the internet will provide you with several options in plain English. Like with any other technical term, people will go out of their way trying to explain it to a lay audience :)

b) following your link, I can see that the author mentions the FTC. That's the problem here. I agree with Charles that the Q must be about prescription drugs.

In the States, these drugs are approved by the FDA; OTC medicine is regulated by the FTC (Federal Trade Commission). In Germany--and Spain, as Charles explained--you are not allowed to advertise the former, while you'll see a message similar to the one Charles mentioned in ads for the latter.

[...]
Arabic & More Apr 16, 2019:
That was a good (excellent) find by Björn, but I would only use "major statement" if your text is highly technical. Even then, I might still provide a definition, because I doubt that the average American has ever heard "major statement" used this way. In my opinion, the average person would think of these statements as television or radio commercial disclaimers, regardless of industry or sector.

https://entertainment.howstuffworks.com/tv-commercial-discla...
Charles Davis Apr 15, 2019:
PS "Major statement", not "main statement", as Björn has privately reminded me. Sorry!
Charles Davis Apr 15, 2019:
I should perhaps add that I think this means advertising of prescription drugs. There is certainly TV advertising of over-the-counter medications in Spain, for example, and they always end with a very rapid spoken and on-screen message saying "read the leaflet and consult your pharmacist". I have no idea whether there's a name for this in Spanish, but it's beside the point anyway.
Charles Davis Apr 15, 2019:
UK English Since Claudia has said that she would prefer US English, and the term she wants in US English is "main statement", as Björn has amply demonstrated, there isn't really any point in looking further. But it is perhaps worth noting that the reason why there seems to be no term for this in British English is that there are no TV ads of this kind in the UK (or Ireland): they're not allowed. The United States and New Zealand are the only two countries in the world in which DTC (direct-to-consumer) advertising of pharmaceuticals is allowed.
https://pharmafield.co.uk/in_depth/pharma-marketing-uk-vs-us...
Björn Vrooman Apr 15, 2019:
Phil I knew someone would make a comment like this. Yes, I can also name it the Chipmunks in the Background, but that wasn't the question.

Claudia specifically wanted to know what this is called as regards to television in the States (see my Q below). Calling a buffalo a mammal isn't wrong. It's just pointless.
philgoddard Apr 15, 2019:
There is no right or wrong answer for terms like this, and disclaimer is fine. You may need to say "high-speed" if that's important to your context.
Björn Vrooman Apr 15, 2019:
PS It's not a "warning section." There are different rules and terms for print and TV ads. See the first link I posted.

Enjoy your day
Björn Vrooman Apr 15, 2019:
Thanks. Then the links below should be right.

Another:
"The 'major statement' is a term that is relevant only to broadcast (TV or radio) ads for prescription drugs. It refers to the presentation of the drug's most important risks. This presentation must be spoken. It also can be included in the video part of TV advertisements."
https://www.fda.gov/drugs/resourcesforyou/consumers/prescrip...

Or:
"FDA intends to review and comment on the first TV ad for a prescription drug or
the first TV ad for a new or expanded indication for an already-approved product. This will allow us to provide feedback on the major statement (i.e., the presentation of risk information in a broadcast ad), which sponsors can apply to both the initial ad and future ads."
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegula...

A glossary (first term): http://www.pharma-mkting.com/glossary/?name_directory_starts...

Best
Claudia Letizia (asker) Apr 15, 2019:
Thanks for your remark. I prefer US English, but either would be fine.
Björn Vrooman Apr 15, 2019:
@Claudia You should specify what EN variant you prefer. In the US, this is called a "major statement":
https://www.fda.gov/drugs/resourcesforyou/consumers/prescrip...

(bottom of page)

and

https://www.lifescienceslegalupdate.com/wp-content/uploads/s...

https://www.lexology.com/library/detail.aspx?g=13a77d04-4ef5...

https://product-liability.weil.com/pharma-medical-devices/fd...

Best I can come up with regarding the UK is warning (message) or summary of product characteristics (SPC): https://assets.publishing.service.gov.uk/government/uploads/...

Best wishes

Responses

+1
1 hr
Selected

warning section (of the ad)

Suggestion

https://www.beckershospitalreview.com/hospital-management-ad...

However, drug companies have to ensure the warning section of the ad is clearly communicated. In 2008, the FDA sent a warning letter to Bayer, stating two ads for the birth control pill Yaz seemed to aim to distract viewers from the potential side effects with a reel of "fast-paced visuals" being shown while the voice actor spoke.
Peer comment(s):

agree philgoddard
1 hr
Thanks!
neutral Yvonne Gallagher : Asker was looking for "a specific term". This is very general
3 hrs
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4 KudoZ points awarded for this answer.
3 hrs

(drug) side effects disclaimer

There are plenty of references online to "(drug) side effects disclaimer". Check out: https://www.google.com/search?q="side effects disclaime...

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Note added at 4 hrs (2019-04-15 14:53:09 GMT)
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This language applies to any medium: print, radio, TV, etc.
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+1
4 hrs

Risk Disclosures

is best I think though "disclaimer" could work. Works for other products as well

http://longevity.stanford.edu/2011/02/04/impact-of-risk-disc...

https://www.jstor.org/stable/30000313?seq=1#page_scan_tab_co...
Peer comment(s):

agree writeaway : I'm ambidextrous UK/US
31 mins
Many thanks:-) And you're US English, right?? //Oh, I thought you were a US native so would recognis(z)e this as US?. The links are US
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20 hrs

television or radio commercial disclaimer

That was a good (excellent) find by Björn, but I would only use "major statement" if your text is highly technical. Even then, I might still provide a definition, because I doubt that the average American has ever heard "major statement" used this way. In my opinion, the average person would think of these statements as television or radio commercial disclaimers, regardless of industry or sector.

https://entertainment.howstuffworks.com/tv-commercial-discla...

I would not personally use "contraindications" disclaimer, as such disclaimers do not only cover contraindications. They also cover side-effects and may also include warnings to see a physician for your specific situation.
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