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Post by u1682002 on Jul 7, 2016 1:33:12 GMT -5
Can they mention Afrezzauser?
can anyone familiar with this type of sale job shed some light on this?
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Post by matt on Jul 7, 2016 6:54:37 GMT -5
Generally speaking, the sales rep must keep the marketing message to the claims that have been allowed on the label for the indications that have been allowed on the label. That is why the label copy is such a big deal when a drug gets approved, and why a "superior to XXXX" is far more powerful than a "not inferior to XXXX" claim.
Reps do get away with providing free handouts that are reprints from medical journals where the article might discuss a medical study (usually far smaller and not as well-controlled as a clinical trial) where the investigator successfully used the drug off-label for some new indication, but it had to be in response to an unsolicited request from the physician. So the rep can't say "Hey doc, have you seen this article about our drug", but if the physician knows about the article they can ask for a copy.
When pharma companies promote beyond the narrow bounds of the label, they can get in trouble with the FDA's Office of Prescription Drug Promotion and, more seriously, can be sued by the Department of Justice for fraudulently promoting medicines for unapproved uses. Since Medicare / Medicaid and other agencies pay for a lot of drugs, this can cost billions in penalties. Pfizer and Lilly have both paid penalties of more than a billion dollars for off-label promotion.
Bottom line, if it isn't on the label the rep can't say much more.
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Post by centralcoastinvestor on Jul 7, 2016 8:33:44 GMT -5
Generally speaking, the sales rep must keep the marketing message to the claims that have been allowed on the label for the indications that have been allowed on the label. That is why the label copy is such a big deal when a drug gets approved, and why a "superior to XXXX" is far more powerful than a "not inferior to XXXX" claim. Reps do get away with providing free handouts that are reprints from medical journals where the article might discuss a medical study (usually far smaller and not as well-controlled as a clinical trial) where the investigator successfully used the drug off-label for some new indication, but it had to be in response to an unsolicited request from the physician. So the rep can't say "Hey doc, have you seen this article about our drug", but if the physician knows about the article they can ask for a copy. When pharma companies promote beyond the narrow bounds of the label, they can get in trouble with the FDA's Office of Prescription Drug Promotion and, more seriously, can be sued by the Department of Justice for fraudulently promoting medicines for unapproved uses. Since Medicare / Medicaid and other agencies pay for a lot of drugs, this can cost billions in penalties. Pfizer and Lilly have both paid penalties of more than a billion dollars for off-label promotion. Bottom line, if it isn't on the label the rep can't say much more. I was wondering if the supplemental studies presented at the 2016 ADA Sessions are fair game to mention at a doctor visit? Particularly, the one study that shows the faster in faster out action of Afrezza. Since the studies were presented at a peer reviewed, prominent diabetes gathering, I would think that could be discussed. Thoughts? |
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Post by anderson on Jul 7, 2016 8:42:25 GMT -5
Burden of proof would be he said vs she said(unless they record sales rep visits) and if the product works like the rep said it would, who is going to push the issue? What people are suppose to do and what people do are totally different. While MNKD can not condone action that is counter to the FDA regulations if they have an sales based incentive program then I am sure some reps will push the envelope to raise their bottom line.
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Post by matt on Jul 7, 2016 9:34:23 GMT -5
I was wondering if the supplemental studies presented at the 2016 ADA Sessions are fair game to mention at a doctor visit? Particularly, the one study that shows the faster in faster out action of Afrezza. Since the studies were presented at a peer reviewed, prominent diabetes gathering, I would think that could be discussed. Thoughts? Good thing to wonder about, but the label is the label is the label. If the supplemental studies are sufficiently powered and controlled to satisfy the FDA, then the company can ask for a change in label copy. That sort of thing happens fairly frequently, but the studies are held to similar standards as the original approval trials. If MNKD can manage a change, that definitely is the way to go. Meanwhile, if the physician asks an unsolicited question about the study presented at the ADA, the salesperson is free to whip out a journal reprint (if the study has been accepted for publication and is not just a poster). The catch is that the physician has to ask for it; the salesman cannot ask a leading question such as "Doctor, did you see the kinetic data presented at the ADA?" The real problem MNKD has with the study to which you refer is that is directly contradicts this sentence: "Despite the faster absorption of insulin (PK) from Afrezza, the onset of activity (PD) was comparable to insulin lispro." That is not a sentence that I made up, that is a direct quote from the FDA approved label for Afrezza. I think if the salesforce were to hit the street with an unapproved claim that directly contradicts what it says in the label it would potentially be a significant issue for the Office of Prescription Drug Promotion. Matt & Mike need to tread very carefully on this point. |
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Post by peppy on Jul 7, 2016 10:15:35 GMT -5
I was wondering if the supplemental studies presented at the 2016 ADA Sessions are fair game to mention at a doctor visit? Particularly, the one study that shows the faster in faster out action of Afrezza. Since the studies were presented at a peer reviewed, prominent diabetes gathering, I would think that could be discussed. Thoughts? Good thing to wonder about, but the label is the label is the label. If the supplemental studies are sufficiently powered and controlled to satisfy the FDA, then the company can ask for a change in label copy. That sort of thing happens fairly frequently, but the studies are held to similar standards as the original approval trials. If MNKD can manage a change, that definitely is the way to go. Meanwhile, if the physician asks an unsolicited question about the study presented at the ADA, the salesperson is free to whip out a journal reprint (if the study has been accepted for publication and is not just a poster). The catch is that the physician has to ask for it; the salesman cannot ask a leading question such as "Doctor, did you see the kinetic data presented at the ADA?" The real problem MNKD has with the study to which you refer is that is directly contradicts this sentence: "Despite the faster absorption of insulin (PK) from Afrezza, the onset of activity (PD) was comparable to insulin lispro." That is not a sentence that I made up, that is a direct quote from the FDA approved label for Afrezza. I think if the salesforce were to hit the street with an unapproved claim that directly contradicts what it says in the label it would potentially be a significant issue for the Office of Prescription Drug Promotion. Matt & Mike need to tread very carefully on this point. Quote : "Despite the faster absorption of insulin (PK) from Afrezza, the onset of activity (PD) was comparable to insulin lispro."
REPLY: The FDA mandated phase 4 Euglycaemic Clamp Study www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf Proves the above statement to be incorrect. THE FDA into giving false information?
Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus
www.clinicaltrials.gov/ct2/show/NCT02470637 information on euglycaemic clamp technique
illingworthresearch.com/2012/07/20/glucose-clamping-in-clinical-trials/
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Post by mnholdem on Jul 7, 2016 10:30:23 GMT -5
I posted this back during the ADA-2016:
In January 2016 the FDA released its long-awaited industry guidance publication, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices".
Link: www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm
While the six articles to be published at the 2016 ADA in New Orleans may or may not not fall under the description, "Unapproved New Uses of Approved Drugs" the FDA document nonetheless provides useful guidance on the distribution of scientific or medical reference publications.
You can use the link above if you wish to read the entire document (it's not very lengthy). Here is an excerpt:
B. Manner in which to Disseminate Scientific and Medical Information
Scientific or medical information that is distributed should:
- be in the form of an unabridged reprint, copy of an article, or reference publication;
- not be marked, highlighted, summarized, or characterized by the manufacturer in any way (except to provide the accompanying disclosures discussed in this section);
- be accompanied by the approved labeling for the drug or medical device;
- be accompanied, when such information exists, by a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies published in medical journals or medical or scientific texts about the use of the drug or medical device covered by the information disseminated (unless the information already includes such a bibliography);
- be disseminated with a representative publication, when such information exists, that reaches contrary or different conclusions regarding the unapproved use; especially those in cases where the conclusions of articles or texts to be disseminated have been specifically called into question by another published article(s) or text(s); and
- be distributed separately from information that is promotional in nature. For example, if a sales representative delivers a reprint to a physician in his office, the reprint should not be physically attached to any promotional material the sales representative uses or delivers during the office visit and should not be the subject of discussion between the sales representative and the physician during the sales visit. Similarly, while reprints may be distributed at medical or scientific conferences in settings appropriate for scientific exchange, reprints should not be distributed in promotional exhibit halls or during promotional speakers' programs.
Read more: mnkd.proboards.com/thread/5598/ada-2016-afrezza-abstracts#ixzz4DjgTKvtz
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As matt stated, "Bottom line, if it isn't on the label the rep can't say much more."
As the FDA points out in the last bullet point (above) any of the new data presented at ADA-2016 in the form of posters or abstracts must be distributed separately from information that is promotional in nature. This makes it a little tougher on a sales rep, but not impossible, to get a discussion going about the latest data, which is considered "off label information".
Also, the key word here is "distributed". The sales rep cannot simply pull out data from an abstract during a sales call. However, abstract(s) can be distributed to the clinic prior to any sales call appointment if it's sent SEPARATELY from any marketing literature related to Afrezza, except for the label (see bullet 4). Later, during a sales call, the sales rep can inquire with the physician whether they received the reprints of abstracts with current data and ask if the physician(s) wants to talk about the latest data available.
What physician won't want to see the "latest available data" about Afrezza?
It's semantics, I know, but the sales reps must be careful how they disseminate and discuss new data that is not on the label. There is a right way and a wrong way to handle it and I would think that Castagna will instruct his team on the correct approach to this issue of discussing new data.
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Post by nylefty on Jul 7, 2016 11:00:44 GMT -5
Maybe this is a dumb question, but I've never seen an explanation of how a sales rep gets credit if a doc the rep has visited starts writing scripts for Afrezza. How does that work?
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Post by agedhippie on Jul 7, 2016 11:17:30 GMT -5
I was wondering if the supplemental studies presented at the 2016 ADA Sessions are fair game to mention at a doctor visit? Particularly, the one study that shows the faster in faster out action of Afrezza. Since the studies were presented at a peer reviewed, prominent diabetes gathering, I would think that could be discussed. Thoughts? Whenever I have presented posters in the past at this sort of event they were never peer reviewed although that was a long time ago and not in the medical field. I would be surprised if that had changed because a big conference like this will have a lot posters and the logistics of getting those reviewed makes it impossible. Only the papers are reviewed normally. |
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Post by Deleted on Jul 7, 2016 11:24:54 GMT -5
Maybe this is a dumb question, but I've never seen an explanation of how a sales rep gets credit if a doc the rep has visited starts writing scripts for Afrezza. How does that work? each rep has a territory and all sales in that territory go to them. and each of those in total cover 50% of insulin market Ex: Mike said , they dont have any for Boston for now |
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Post by nylefty on Jul 7, 2016 11:43:28 GMT -5
Maybe this is a dumb question, but I've never seen an explanation of how a sales rep gets credit if a doc the rep has visited starts writing scripts for Afrezza. How does that work? each rep has a territory and all sales in that territory go to them. and each of those in total cover 50% of insulin market Ex: Mike said , they dont have any for Boston for now Many people now get their prescriptions filled by mail order (I get mine from Caremark). I assume that the reps don't get credit for all those scripts. |
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Post by Deleted on Jul 7, 2016 11:50:34 GMT -5
each rep has a territory and all sales in that territory go to them. and each of those in total cover 50% of insulin market Ex: Mike said , they dont have any for Boston for now Many people now get their prescriptions filled by mail order (I get mine from Caremark). I assume that the reps don't get credit for all those scripts. in that case, i hope who ever aggregates the sales data in intelligent enough to consider the patient location as point of sale rather than the warehouse. |
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Post by nylefty on Jul 7, 2016 11:57:47 GMT -5
Many people now get their prescriptions filled by mail order (I get mine from Caremark). I assume that the reps don't get credit for all those scripts. in that case, i hope who ever aggregates the sales data in intelligent enough to consider the patient location as point of sale rather than the warehouse. How would they know the patient location? I doubt that Caremark breaks it down that way for Symphony, assuming that Caremark gives sales numbers to Symphony (which they may or may not do). |
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Post by Deleted on Jul 7, 2016 12:10:11 GMT -5
in that case, i hope who ever aggregates the sales data in intelligent enough to consider the patient location as point of sale rather than the warehouse. How would they know the patient location? I doubt that Caremark breaks it down that way for Symphony, assuming that Caremark gives sales numbers to Symphony (which they may or may not do). You or I dont know whats randomized and shared. So I will leave it there. |
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Post by bradleysbest on Jul 7, 2016 12:33:09 GMT -5
Are the Afrezza reps on salary plus commission for each script? Not sure how it works so any info is appreciated.
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