FDA’s Off-Label Guidance: Fantasy Or Framework?
8 CommentsBy Ed Silverman // April 25th, 2008 // 12:20 pm
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 That’s the question asked by Health Affairs in response to the recently issued FDA draft guidance that would permit this to occur.
So the journal ran diametrically opposing views from Jerome Kassirer, a Tufts University School of Medicine professor and former editor-in-chief at the New England Journal of Medicine, and Scott Gottlieb, a resident fellow at the American Enterprise Institute, a medical internist at Stamford Hospital, a former FDA deputy commish for medical and scientific affairs and a consultant to Novartis. The upshot? Here are excerpts…
Kassirer: “The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking. Anthropologist Philips Stevens Jr. says that magical thinking invests symbols with special powers and forces. Peer review and disclosure are two of these powerful symbols, and, in my opinion, both have been afforded far more credibility than they deserve…
“…For my money, once there is a reasonable suspicion that an already approved drug might have a new use, it must be examined in the same rigorous way as the approved use. At the very least, detailed post-marketing surveillance, as practiced in other countries, should be mandatory. All new indications for a drug should be examined by the FDA for efficacy and toxicity before a company can market the drug for a new use. Regulatory scrutiny of off-label drugs should not be relaxed.
“By requiring peer review, disclosure, and editorial-board expertise, the new FDA guidance offers a veneer of credibility and respectability, but if you scratch this glossy surface, you find more marketing, more inappropriate drug use, more expense, and more adverse consequences. If I learned that my doctor was getting his information from industry-paid lecturers, in seminars sponsored by drug companies, or from reprints selectively given to him from drug reps, I’d get another doctor.”
Gottlieb: “…not all off-label information and promotional activities are equal when it comes to matters of health. Even stalwart critics of pharmaceutical promotion might be hard pressed to defend the idea that medical practice in fast-moving fields such as oncology should be defined solely by the information contained within drug labels, and not off-label drug information contained in the medical literature…”
“…Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. This standard may provide an efficient way to enforce the law, but establishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.
Laurie
“The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking”
That’s it in a nutshell!
pharma PR hack
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
Laurie
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.
Jack2
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.
Sickening
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.
Doc
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.
David Hamilton
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.
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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…