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Spirometry
Jan 29, 2016 13:36:11 GMT -5
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Post by patten1962 on Jan 29, 2016 13:36:11 GMT -5
Does anyone know if this testing needs to be done before Affrezza can be used?
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Post by Deleted on Jan 29, 2016 13:42:20 GMT -5
seriously? are you for real ?
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Post by peppy on Jan 29, 2016 13:42:59 GMT -5
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Post by kbrion77 on Jan 29, 2016 13:46:17 GMT -5
seriously? are you for real ? There are so many new topics and questions being asked by new members that I feel the intention is to lead the discussion to a negative avenue. It's just as annoying as people asking about a $50 BO. |
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Post by ricguy on Jan 29, 2016 13:46:54 GMT -5
This thread has got to be a joke. Should be locked.
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Post by mindovermatter on Jan 29, 2016 13:54:44 GMT -5
Does anyone know if this testing needs to be done before Affrezza can be used? It is a requirement but technically a doctor does not have to have it done. I don't believe a pharmacist requires to see spirometry results in dispensing the drug. |
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Post by hankscorpio7 on Jan 29, 2016 14:09:53 GMT -5
Nice work peppy and mindover- making this board a better place.
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Spirometry
Jan 29, 2016 14:11:37 GMT -5
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Post by patten1962 on Jan 29, 2016 14:11:37 GMT -5
seriously? are you for real ? Don't like your tone. I am long on this and was just talking to a physician about this! Don't understand u know it all people? I am asking a question. What 8s your problem??? |
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Spirometry
Jan 29, 2016 14:13:11 GMT -5
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Post by patten1962 on Jan 29, 2016 14:13:11 GMT -5
Does anyone know if this testing needs to be done before Affrezza can be used? It is a requirement but technically a doctor does not have to have it done. I don't believe a pharmacist requires to see spirometry results in dispensing the drug. Was told by a physician a Sanofi rep told him it was. And Sanofi provides the testing to the office. |
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Spirometry
Jan 29, 2016 14:15:19 GMT -5
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Post by patten1962 on Jan 29, 2016 14:15:19 GMT -5
seriously? are you for real ? There are so many new topics and questions being asked by new members that I feel the intention is to lead the discussion to a negative avenue. It's just as annoying as people asking about a $50 BO. I find your condescending attitude annoying |
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Post by matt on Jan 29, 2016 15:19:40 GMT -5
The FDA regulates the sale, manufacture, and distribution of drugs. Physicians are licensed by the state in which they practice. Technically, the FDA cannot order physicians to do, or not do, anything, which is why physicians can prescribe drugs for "off label" use at their discretion if they feel it is in the best interest of their patient.
However, physicians normally pay close attention to what the FDA says because ultimately they are legally responsible for what happens to the patient. If a physician prescribes Afrezza without a spirometer test and the patient develops complications that the test would have detected, that is a malpractice case waiting to happen. Similarly, if a physician prescribes a medication for "off label" use and the patient has an adverse event, that does not look good for the physician.
So the answer is that the physicians can do what they please, but they do so at their own risk. Sanofi is regulated by FDA so their salesmen cannot market in any way that reflects claims not approved by FDA, or market contrary to what is on the approved label copy. If you want to assert that this situation is not logical, I will not disagree with you!
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Post by parrerob on Jan 29, 2016 15:27:54 GMT -5
Thanks Matt very clear and interesting.
Up to me it is logical too. It is correct that Marketing and promotion must follow label rules while a physician can prescribe differently... A physician is a doctor and sure should decide what is better for his patient.
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Spirometry
Jan 29, 2016 15:36:31 GMT -5
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Post by patten1962 on Jan 29, 2016 15:36:31 GMT -5
The FDA regulates the sale, manufacture, and distribution of drugs. Physicians are licensed by the state in which they practice. Technically, the FDA cannot order physicians to do, or not do, anything, which is why physicians can prescribe drugs for "off label" use at their discretion if they feel it is in the best interest of their patient. However, physicians normally pay close attention to what the FDA says because ultimately they are legally responsible for what happens to the patient. If a physician prescribes Afrezza without a spirometer test and the patient develops complications that the test would have detected, that is a malpractice case waiting to happen. Similarly, if a physician prescribes a medication for "off label" use and the patient has an adverse event, that does not look good for the physician. So the answer is that the physicians can do what they please, but they do so at their own risk. Sanofi is regulated by FDA so their salesmen cannot market in any way that reflects claims not approved by FDA, or market contrary to what is on the approved label copy. If you want to assert that this situation is not logical, I will not disagree with you! Matt. Thank you for a great answer. Not sure why my question struck a nerve? This is what a physician told me today. |
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Post by parrerob on Jan 29, 2016 15:59:23 GMT -5
seriously? are you for real ? There are so many new topics and questions being asked by new members that I feel the intention is to lead the discussion to a negative avenue. It's just as annoying as people asking about a $50 BO. Just a suggestion: Why not to create a session something like a FAQ ? Yes I know, I am proposing additional tasks for moderators, but sure it will be great will avoid space consumption and could be a very good information for new members, new investor, and old member too .... the "search" tool is totally different ! test for example "spirometry" You will get 28 pages..... |
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Post by sccrbrg on Jan 29, 2016 16:13:48 GMT -5
There are so many new topics and questions being asked by new members that I feel the intention is to lead the discussion to a negative avenue. It's just as annoying as people asking about a $50 BO. Just a suggestion: Why not to create a session something like a FAQ ? Yes I know, I am proposing additional tasks for moderators, but sure it will be great will avoid space consumption and could be a very good information for new members, new investor, and old member too .... the "search" tool is totally different ! test for example "spirometry" You will get 28 pages..... Spirometry has probably been the single most talked about barrier to market followed closely by insurance. Information on the spirometry requirement is literally everywhere - if someone hasn't heard about it they have probably done virtually zero due diligence. I don't see how adding all of the information that is already readily available will eliminate these threads. Instead of saying "learn how to use the search tool", we'll just be saying "Read the FAQ". |
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