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Post by nylefty on Aug 2, 2019 9:39:33 GMT -5
The FDA Division of Drug Marketing, Advertising, and Communication has held sponsored links misbrand drugs if they include the name of the drug plus a claim and, therefore, must disclose risk and other information about the drug. Mannkind could sponsor advertising of Afrezza using the name Afrezza, but could not mention that it is a type of insulin of that it is used to treat diabetes. Conversely, Mannkind could talk about insulin or diabetes without mentioning Afrezza. To date the agency has not cut pharmaceutical companies any slack for space limitations such as Twitter messages limited to 140 characters. Once a communication mentions both the name of the drug and a benefit then the full prescribing information, including the black box, must be included. The rules are subject to change, but this has been the FDA's articulated policy for the last 11 years. That's not what the FDA says on its website. You're saying that MannKind could sponsor "reminder ads," but reminder ads are specifically NOT allowed for drugs with "boxed warnings." "Reminder ads give the drug's name but not the drug's use. The assumption behind reminder ads is that the audience knows what the drug is for and does not need to be told. A reminder ad does not contain risk information about the drug because the ad does not discuss the condition treated or how well the drug works.Reminder ads are not appropriate for drugs whose labeling has a "boxed warning" about certain very serious drug risks."
That's why the wording on the Indy car said "MannKind Diabetes," and not Afrezza. www.fda.gov/drugs/prescription-drug-advertising/reminder-ad-correct |
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Post by centralcoastinvestor on Aug 2, 2019 9:52:20 GMT -5
PWDs may not care much about inhaling, but they do seem to like progress (towards a cure or better lifestyle/treatment) or at least another handy tool in the tool box. Also, I suspect the novelty of taking prandial insulin with the meal (or even after starting it) will not be lost on PWDs. And, I like that the website emphasizes Afrezza gets in the bloodstream within seconds of administration and working effectively within ~12 minutes. Absolutely nobody is against options and another tool in the toolbox is always welcome. Saying you can't have ice cream because you haven't pre-bolused is just silly though, and no needles is largely irrelevant. If no needles resonated strongly then at some point in the last four and a half years sales would have taken off - that approach is one thoroughly beaten horse. If I was designing an advert to appeal to diabetics I would ignore no needles entirely and focus on speed to achieve a correction, and on predictability. I don't care if I inhale, drink, or inject insulin. Likewise if I always take insulin at the start of eating then why does not needing to pre-bolus matter? What I care about is in practical terms how this particular insulin makes my life immediately better. Benefits and not features. I don’t think any advertising campaign would work for you. You are pretty set in your ways of doing things. That is not true of all people especially the younger generation. You have been on this board for a long time and know a lot about Afrezza and yet have never tried it. That amazes me. |
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Post by matt on Aug 2, 2019 9:56:53 GMT -5
Reminder ads presume the patients know the drug and its uses. If a drug has such a low visibility the presumption that it is a reminder ad is rebuttable. A lot depends on where the advertising is targeted and previous promotional attempts; ultimately it comes down to a facts and circumstances test. At any rate the debate may well be moot because a broad, untargeted promotion of a brand name with no context is likely a huge waste of money, and a targeted campaign directed at diabetics would presume that the readers would know about the uses (and therefore run afoul of the guidance on reminder ads). Regardless of where you draw the line, the FDA rules are not very helpful to MNKD.
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Post by longliner on Aug 2, 2019 9:58:02 GMT -5
PWDs may not care much about inhaling, but they do seem to like progress (towards a cure or better lifestyle/treatment) or at least another handy tool in the tool box. Also, I suspect the novelty of taking prandial insulin with the meal (or even after starting it) will not be lost on PWDs. And, I like that the website emphasizes Afrezza gets in the bloodstream within seconds of administration and working effectively within ~12 minutes. Absolutely nobody is against options and another tool in the toolbox is always welcome. Saying you can't have ice cream because you haven't pre-bolused is just silly though, and no needles is largely irrelevant. If no needles resonated strongly then at some point in the last four and a half years sales would have taken off - that approach is one thoroughly beaten horse. If I was designing an advert to appeal to diabetics I would ignore no needles entirely and focus on speed to achieve a correction, and on predictability. I don't care if I inhale, drink, or inject insulin. Likewise if I always take insulin at the start of eating then why does not needing to pre-bolus matter? What I care about is in practical terms how this particular insulin makes my life immediately better. Benefits and not features. I find both points relevant, particularly with Pediatrics coming. The advantage of speed is very clear in the commercial. The needle goes back to "The Shiv" asking the child, would you rather stab yourself with this needle or inhale from this cute whistle? On a side question, do you spend this amount of time writing on message boards about diabetes products you DO use? If so which ones? |
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Post by agedhippie on Aug 2, 2019 10:03:57 GMT -5
I don’t think any advertising campaign would work for you. You are pretty set in your ways of doing things. That is not true of all people especially the younger generation. You have been on this board for a long time and know a lot about Afrezza and yet have never tried it. That amazes me. Fair comment. My suggestion was based on what diabetics in general care about though, not on what would make me personally change. Don't under-estimate how set in their ways diabetics are, the sales figures are proof of that! You are asking for a lifestyle change and those are hard to get people to do so you have to show solid benefit hence my list. |
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Post by od on Aug 2, 2019 10:06:35 GMT -5
As a marketer (primarily pharma) my north star has always been ‘What’s the message, who’s the audience’. At 30,000 feet, this is an interesting campaign, but I am confused by the video. I get the message, but If I was diabetic, I would want the video speaking directly to me, not to non-diabetics. Aged, your thoughts; am I missing something? It's unrealistic. I think you lose the diabetic audience at the point he claims you have to take insulin and wait 15 minutes before you eat. That's going to be met with hilarity. The needles part feels like it was tacked on because the people producing the advert utterly believe that is a market changer despite the evidence up to this point. I get it, needles sound horrible to non-diabetics, but if you are injecting it's a minor concern. Cute advert though so it works at that level. It feels like it is aimed at non-diabetics to get them to talk to their diabetic friends and that may be an approach (but if any of my non-diabetic friends tells me how to manage my diabetes they are going to get a slap) I agree the video could be a vehicle for non-diabetics to tell there diabetic friends about a new option, but I think a bit (way) too early to be looking for that perimeter. |
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Post by cretin11 on Aug 2, 2019 10:08:47 GMT -5
aged, is that correct, you've never even tried Afrezza? Aren't you curious about how you'd feel on it? (I'm not a PWD and there's absolutely no judgment intended in my Qs)
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Post by sweedee79 on Aug 2, 2019 10:14:37 GMT -5
The video is brilliant.. it not only speaks to people who are non-diabetic..but also lends a bit of understanding about what it's like to have diabetes..and it also is a message to PWD that there is an easier way.. you don't have to wait for your icecream... !!!! I love it!!
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Post by agedhippie on Aug 2, 2019 10:14:41 GMT -5
I find both point relevant, particularly with Pediatrics coming. The advantage of speed is very clear in the commercial. The needle goes back to "The Shiv" asking the child, would you rather stab yourself with this needle or inhale from this cute whistle? On a side question, do you spend this amount of time writing on message boards about diabetes products you DO use? If so which ones? I think pediatrics is a softer target. As to the point "The Shiv" nobody is giving kids that choice. If you go to my clinic (a very large hospital group diabetes clinic in NY) that child be put on a pump and CGM immediately. I am not arguing that this is the correct route, I am just saying what is. The parents are in a state of shock and are unlikely to argue, and the endos think it's the best approach. Down the road there is scope to move kids off pumps and onto Afrezza, Sports friend Tom's kids being a great example. Pediatric adverts are somewhere this ad would work better because you have people making decisions for diabetics. I think there is definitely scope there. Edit: Whoops. Where else to I go? Tudiabetes, but I rarely post because I agree with most of what I read. |
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Post by goyocafe on Aug 2, 2019 10:15:52 GMT -5
aged, is that correct, you've never even tried Afrezza? Aren't you curious about how you'd feel on it? (I'm not a PWD and there's absolutely no judgment intended in my Qs) Kinda like the Life cereal commercial. “You try it”, “No, you try it!”. “Let’s get Aged to try it.” “Hey, Aged!, he likes it” m.youtube.com/watch?v=vYEXzx-TINc |
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Post by cretin11 on Aug 2, 2019 10:19:50 GMT -5
Classic! "Aged won't like it, he hates everything!" "He likes it! Hey Aged!"
(And that was a damn tasty cereal, i guess still is but i don't partake in cereal anymore.)
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Post by sluggobear on Aug 2, 2019 10:35:04 GMT -5
I don’t think any advertising campaign would work for you. You are pretty set in your ways of doing things. That is not true of all people especially the younger generation. You have been on this board for a long time and know a lot about Afrezza and yet have never tried it. That amazes me. Fair comment. My suggestion was based on what diabetics in general care about though, not on what would make me personally change. Don't under-estimate how set in their ways diabetics are, the sales figures are proof of that! You are asking for a lifestyle change and those are hard to get people to do so you have to show solid benefit hence my list. After I bought way too much mnkd stock (I still hold it), I asked a T1D friend of mine what he thought about the idea of inhaled insulin. He and I worked together in biotech R&D, both PhDs. I was dismayed at his lack of interest. Over a 10y time period, I traveled all over the world with him for work, watched him get way too drunk, and saw him crash numerous times. His lack of interest fits exactly with what Aged has been saying for a long time. In my limited experience with diabetics, that was an eye opener. I should have done more DD at that point. I had years of research in drug delivery, tissue engineering. I thought afrezza would be huge but adoption of new med tech is fraught. My take now (Capt obvious): long term diabetics find a formula that works and are resistant to change... ESPECIALLY when the new thing is incredibly expensive. I hope the pediatric population will be more amenable to afrezza. |
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Post by harryx1 on Aug 2, 2019 10:37:51 GMT -5
I agree with sweede, it's all about being able to be spontaneous and not having to think about diabetes and always planning around it. It's about having some Freedom, I'll give you a couple of examples....    |
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Post by prcgorman2 on Aug 2, 2019 10:56:31 GMT -5
PWDs may not care much about inhaling, but they do seem to like progress (towards a cure or better lifestyle/treatment) or at least another handy tool in the tool box. Also, I suspect the novelty of taking prandial insulin with the meal (or even after starting it) will not be lost on PWDs. And, I like that the website emphasizes Afrezza gets in the bloodstream within seconds of administration and working effectively within ~12 minutes. Absolutely nobody is against options and another tool in the toolbox is always welcome. Saying you can't have ice cream because you haven't pre-bolused is just silly though, and no needles is largely irrelevant. If no needles resonated strongly then at some point in the last four and a half years sales would have taken off - that approach is one thoroughly beaten horse. If I was designing an advert to appeal to diabetics I would ignore no needles entirely and focus on speed to achieve a correction, and on predictability. I don't care if I inhale, drink, or inject insulin. Likewise if I always take insulin at the start of eating then why does not needing to pre-bolus matter? What I care about is in practical terms how this particular insulin makes my life immediately better. Benefits and not features. With respect to the bolded sentence I assume you're referring to a non-standard practice of a PWD using needle/pen + RAA.
The dosing instructions for Afrezza when it launched in early 2015 was developed according to FDA approval and guidelines. I assumed the reference to the 15 minute interval of pre-bolus before meal was a reference to the instructions for RAA insulins.
Based on what I've read and PWDs I've known, I've assumed the big lifestyle advantage of inhaling Afrezza with the meal was freedom. Freedom to choose the dose when the meal arrives, and adjust, if needed, the dose to the meal instead of the other way around. And the freedom to dose with less of a stigma at the table instead of in the bathroom (if at a restaurant). And the freedom of stacking without as much concern about a long tail and having to snack to deal with a hypoglycemic event.
These are all the perceptions of a non-PWD, so I may be wrong or put too much emphasis on these benefits.
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Post by sweedee79 on Aug 2, 2019 11:09:18 GMT -5
I'd rather inhale human insulin than inject poisen if I had the choice.. and eat when I want to like everyone else..
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