Comments on: FDA’s Off-Label Guidance: Fantasy Or Framework? http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/ News, Comment and Conversation Fri, 10 Feb 2012 22:22:31 +0000 http://wordpress.org/?v=2.6.2 By: www.worldpharmanews.net http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-317470 www.worldpharmanews.net Sun, 27 Apr 2008 09:53:36 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-317470 <strong>Pharmalot » FDA's Off-Label Guidance: Fantasy Or Framework?...</strong> Should drug and device makers be allowed to provide docs with medical and scientific journal articles concerning uses of their products that have not been approved by the FDA? That's the question asked by Health Affairs in response to the recently iss... Pharmalot » FDA’s Off-Label Guidance: Fantasy Or Framework?…

Should drug and device makers be allowed to provide docs with medical and scientific journal articles concerning uses of their products that have not been approved by the FDA? That’s the question asked by Health Affairs in response to the recently iss…

]]> By: David Hamilton http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-315943 David Hamilton Sat, 26 Apr 2008 12:01:22 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-315943 It never fails to amaze me how someone like Gottlieb can so easily conflate "scientific" and "commercial" speech. Of course no one is saying oncologists shouldn't discuss the scientific literature and use it to fashion cutting-edge, off-label treatments -- just that there's no reason they need drug reps pushing half-baked studies at them to facilitate that sort of communication. Last time I checked, tens of thousands of oncologists attend conferences like ASCO, and they have ready access to journals and journal clubs, online forums like Sermo, emerging open-source science communities and the like. Oncologists have no shortage of ways to stay up-to-date with their peers; the idea that they need to be force-fed information by drug reps is patronizing in the extreme. It never fails to amaze me how someone like Gottlieb can so easily conflate “scientific” and “commercial” speech. Of course no one is saying oncologists shouldn’t discuss the scientific literature and use it to fashion cutting-edge, off-label treatments — just that there’s no reason they need drug reps pushing half-baked studies at them to facilitate that sort of communication.

Last time I checked, tens of thousands of oncologists attend conferences like ASCO, and they have ready access to journals and journal clubs, online forums like Sermo, emerging open-source science communities and the like. Oncologists have no shortage of ways to stay up-to-date with their peers; the idea that they need to be force-fed information by drug reps is patronizing in the extreme.

]]> By: Doc http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314540 Doc Fri, 25 Apr 2008 20:01:03 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314540 Note to Mr. Gottlieb: Do you really want the 28 year old daughter of your neighbor, who until last month was selling cell phones, now going into your parent's oncologist pumping their drug for off-label use in order to win an award trip to Mexico? Doctors are free to use drugs off-label if they so choose, allowing pharma company sales forces to hype those uses is an entire different issue. Note to Mr. Gottlieb:

Do you really want the 28 year old daughter of your neighbor, who until last month was selling cell phones, now going into your parent’s oncologist pumping their drug for off-label use in order to win an award trip to Mexico? Doctors are free to use drugs off-label if they so choose, allowing pharma company sales forces to hype those uses is an entire different issue.

]]> By: Sickening http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314535 Sickening Fri, 25 Apr 2008 19:56:19 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314535 In my opinion, Gottlieb's position is a joke. If a licensed physician makes a medical decision to utilize a prescription drug for an indication that is not approved, he/she is free to do so and should be held responsible for his/her actions. Informed physicians in medical specialties that prescribe drugs off-label educate themselves by reading journals and attending CME conferences. If a pharmaceutical company promotes its drugs for off-label use, then it commits an illegal act and should be held accountable for its' actions. Pharma is a regulated industry and the companies simply need to get used to it. perhaps these companies should take the Hippocratic Oath - "first do no harm." When companies hand out articles, they frequently put them in brightly-colored advertising holders with their spin. Not only that, you don't know who actually wrote the article - a drug company employee, a vendor or the supposed author. In my opinion, Gottlieb’s position is a joke.

If a licensed physician makes a medical decision to utilize a prescription drug for an indication that is not approved, he/she is free to do so and should be held responsible for his/her actions. Informed physicians in medical specialties that prescribe drugs off-label educate themselves by reading journals and attending CME conferences.

If a pharmaceutical company promotes its drugs for off-label use, then it commits an illegal act and should be held accountable for its’ actions. Pharma is a regulated industry and the companies simply need to get used to it. perhaps these companies should take the Hippocratic Oath - “first do no harm.” When companies hand out articles, they frequently put them in brightly-colored advertising holders with their spin. Not only that, you don’t know who actually wrote the article - a drug company employee, a vendor or the supposed author.

]]> By: Jack2 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314479 Jack2 Fri, 25 Apr 2008 19:13:04 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314479 I've posted it here about ten times now, but this stipulation in the guidance makes this new or revised guidance practically meaningless... A scientific or medical reference publication that is distributed should not be...edited or significantly influenced by a drug or device manufacturer or any individuals having a financial relationship with the manufacturer. I’ve posted it here about ten times now, but this stipulation in the guidance makes this new or revised guidance practically meaningless…

A scientific or medical reference publication that is distributed should not be…edited or significantly influenced by a drug or device manufacturer or any individuals having a financial relationship with the manufacturer.

]]> By: Laurie http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314403 Laurie Fri, 25 Apr 2008 17:39:27 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314403 If we give carte blanche to offlabel prescribing then we also have to place full liability on the pharmaceutical companies that make the drug and the doctors that prescribe them, for any problems that arise. Also required should be informed consent to the patient, so they KNOW that the drug is being used based on someones "opinion",or a medical journal article that was potentially ghostwritten by the manufacturer of that drug, and not necessarily scientific evidence. This whole thought is just SO disturbing to me. What happens to long term use studies, adverse reaction monitoring if these drugs are used for whatever indication a doctors feels is OK? Is this really what we want as a society..I don't think so. If we give carte blanche to offlabel prescribing then we also have to place full liability on the pharmaceutical companies that make the drug and the doctors that prescribe them, for any problems that arise. Also required should be informed consent to the patient, so they KNOW that the drug is being used based on someones “opinion”,or a medical journal article that was potentially ghostwritten by the manufacturer of that drug, and not necessarily scientific evidence.
This whole thought is just SO disturbing to me. What happens to long term use studies, adverse reaction monitoring if these drugs are used for whatever indication a doctors feels is OK? Is this really what we want as a society..I don’t think so.

]]> By: pharma PR hack http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314396 pharma PR hack Fri, 25 Apr 2008 17:28:12 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314396 This seems more like positioning to cut off at the knees the onslaught of state attorney general suits for off label marketing. Physicians who subscribe to the journals can read the articles without the help of a pharma abstract copy This seems more like positioning to cut off at the knees the onslaught of state attorney general suits for off label marketing.

Physicians who subscribe to the journals can read the articles without the help of a pharma abstract copy

]]> By: Laurie http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314363 Laurie Fri, 25 Apr 2008 16:49:39 +0000 http://www.pharmalot.com/2008/04/fdas-off-label-guidance-fantasy-or-framework/#comment-314363 “The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking" That's it in a nutshell! “The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking”

That’s it in a nutshell!

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