New Commercial down the road

[prcgorman2]

I found a few things that may help the discussion.

First I found an FDA "draft" of "...Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability".

The draft is available at URL: www.federalregister.gov/documents/2012/03/13/2012-6040/draft-guidance-for-industry-on-direct-to-consumer-television-advertisements-the-food-and-drug?source=govdelivery

Second, I found an informative article posted in 2012 discussing the draft and titled, "FDA: FDAA DTC Television Ad Pre-Dissemination Review Program".

The article is available at URL: www.policymed.com/2012/03/fda-fdaa-dtc-television-ad-pre-dissemination-review-program.html.

Third, I found an update to the Code of Federal Regulations (CFR) published in November of last year which updates DTC guidelines related to "...the major statement relating to side effects and contraindications...".

The final rule is available at URL: www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear#:~:text=This%20final%20rule%20implements%20a,side%20effects%20and%20contraindications%20(major

FWIW, I'm unsure whether the draft published by the FDA in 2012 is what the FDA is still basically working from. i.e., I wasn't able to easily discover if there was ever a final non-draft version published.

[casualinvestor]

I'd work more on the parent's angst, and show a kid at a doctor's office talking to Mom. Kid: "I need to get shots every day!?" Mom: "No sweety, they have inhaled insulin that does the exact same thing" Cut to kid taking a long puff. For DTC and pediatrics, there's no need to get complicated about speed of action or other things. Just make sure they know there's a needle free insulin choice.

Quick spot, could even not mention Afrezza at all to avoid a bunch of regulation. It's not like there's another inhaled insulin

[prcgorman2]

Since I think we're discussing pediatric Type 1, I kind of think it won't be possible to advertise that needles won't be needed. I assume kids need a basal insulin like Lantus in conjunction with a mealtime (i.e., prandial) insulin like Afrezza, or go on a pump.

[cretin11]

Nov 12, 2024 10:54:08 GMT -5 parrerob said:

In a house a child runs chased by a large syringe... he runs, pants and runs and finally reaches the kitchen, catches his white and blue Dreamboat and inhales quickly... the syringe at that point desperately falls to the ground and disintegrates.... 


At that point the message "Needless is just one of the many benefits" appears on the screen, then some data scrolls showing reaction time, AC1 etc etc....

at the end, on the screen, precautions etc etc ...

For the second part I still have to read the FDA rules for marketing (sorry)...... "just one of the many benefits" not sure can be posted....

Music suggested 

Another good one, parrerob.  For music, something like the scary theme song from the Halloween hack'n'slay movies for the first part of the commercial.  Then when he uses the Dreamboat it transitions to something like "Celebrate" by Kool and the Gang.

When we get a cut of the referral fees from MNKD for when they incorporate all these brilliant ad ideas (saving them thousands of dollars off the marketing budget), we'll be sure to let y'all know and divide it up fairly.  

[ktim]

Nov 12, 2024 8:59:03 GMT -5 patience1 said:

Here is an idea for the commercial. Why not tract a real teens A1c and time in range, not use actors and just tell the Truth? Can you imagine a commercial where the drug company is actually telling the truth.

That type of anecdotal claim/example is absolutely not allowed by FDA in commercials for drugs.  

Supplement companies do it all the time, but they aren't regulated like pharma commercials.

[peppy]

I wish the commercial could straight out say, Afrezza enters the blood stream quickly, peaks at 35 mins and out of the system in 90 mins.

Perhaps a commercial with insulin and outsulin.     I could not find one picture of insulin and outsulin.

x.com/TheHarryx1/status/1766135262663356763/photo/1

[cretin11]

No more “outsulin” please. Can’t remember whose idea that was, but it was a complete fail.

[prcgorman2]

I prefer to think of that marketing as "ouch-sulin" even though Afrezza is an "ouch-less" product (but the "ouch-less" marketing claim may belong to Medline).

[patience1]

The FDA is not consistent and what they allow and who they pursue for violations.  The Covid-19 vaccines are a prime example.  There was a lot said by reps, news stations, the head of the CDC and even politicians that was allowed and later leaned to be not true.

[peppy]

My compliant is with health insurance, The insurer gets to pick which brand of insulin it covers being that they are considered non-inferior.
Then the insurer gets a kick back for meeting sales targets. Called a rebate.

Words, between the lines of age. Tricky, tricky.

when I file that compliant it ends up in the circular file.

[prcgorman2]

And hence the best prandial insulin product that the world has ever seen is held captive by the price competition from the established BPs.

MannKind has to be able to either offer Afrezza at a discount to $35/month prandial insulin competitors, or prove that the extra value is worth the extra cost. Ouch.

Much easier to compete(-ish) on price than it is to prove a non-competitive (otherwise) prandial insulin is worth the xtra cost. Now you’re having to convince, insurers, doctors, and patient (wallets). Oof.

[cretin11]

Nov 12, 2024 19:07:35 GMT -5 peppy said:

My compliant is with health insurance, The insurer gets to pick which brand of insulin it covers being that they are considered non-inferior.
Then the insurer gets a kick back for meeting sales targets. Called a rebate.

Words, between the lines of age. Tricky, tricky.

when I file that compliant it ends up in the circular file.

I think you mean “complaint” - but kudos on the excellent Neil Young reference 👍🏼

[agedhippie]

Please, never ever write an advert showing a syringe, those went out years ago. These days it's all pens or pumps.

If you are looking at the pediatrics market it's all pumps if they have insurance cover. The endos like these because the AID pumps are giving a good TIR, and getting better. With one injection every three days there are fewer injections with a pump than with Afrezza.

That will be what the endos will say. The counter argument for Afrezza is superior results in the trial data, not a lack of needles.

[casualinvestor]

I'd say that DTC marketing (if it ever happens again, and now is not the time IMO) should mention lack of needles. It's a way to get parents to ask their doctor about Afrezza

[agedhippie]

Nov 13, 2024 9:26:11 GMT -5 casualinvestor said:

I'd say that DTC marketing (if it ever happens again, and now is not the time IMO) should mention lack of needles. It's a way to get parents to ask their doctor about Afrezza

The problem is getting the endo to respond positively. Right now the perceived wisdom is that AID pumps are the way to go for kids because the pump deals with a lot of the dosing itself which leads to better numbers. It's going to take a lot to change that which is not to say that there will be zero uptake. Personally I would look for a 30% increase in Afrezza sales as a wild guess.