I just saw this article and, on the face of it this sounds like a very tenuous situation. In brief, the FDA is saying that as long as there is peer reviewed data supporting the off-label (i.e. not FDA approved use) the drug maker can promote the data and, therefore, the off-label use. I do not, in general, have a problem with off-label use. I think that physicians have a great deal to gain by using their experience and knowledge from colleagues about what drugs to use to treat particular diseases. However, in light of the recent findings of the failure of agencies (public and private) to keep tabs on conflicts of interest this latest maneuver by the FDA looks ripe for abuse.
On the other hand maybe I will start the Journal of Off-Label Uses – a “peer-reviewed” journal sponsored by GSK, Pfizer, Roche, etc.
I read this story on Medscape, which details some of the restrictions associated with the new guidelines. Off-label uses of drugs certainly are important. By the sounds of the Medscape article, the FDA have found a way to get pharma reps to do free publicity for such uses without them going off on the standard inflated sales pitch.
The restrictions include:
Thanks Helen,
One of this issues to consider is the first – Reps not allowed to discuss the journal article with the physician. This will be very difficult to police not just in the one-on-one sales situation but also at the Continuing Education retreats that the Pharma sponsor. Also, I think we need to have a serious discussion on the presentation of clinical trial data on FDA approved drugs (and uses) in peer-reviewed papers. Are we are all satisfied that an unbiased approach is currently in use? If so is the current approach still viable for the model for evaluating “unapproved” uses?
I just saw this article in the new Nature Biotechnology (Nature Biotechnology 27, 21 (2009)) – it may be worth reading for this discussion
Hmm, yeah, the restrictions stipulated in the FDA’s guidelines are a good effort but I doubt it will be possible to police these limitations in real life.
The Nature Medicine blog A spoonful of medicine has just published a short post on this issue. The post helpfully links to a PDF of the new guidelines, which should help us get a better handle on the restrictions.
Thanks Helen,
I just read the guidance PDF and several points strike me. 1) As a guidance document it does not establish legally enforceable rights or responsibilities. 2)The reference publications shared should be “truthful and not misleading”. This looks very gray to me. In fact the phrase ‘lies, damn lies and statistics’ popped into my mind. As stated earlier there is already concern about how well conflict of interest disclosures are enforced (i.e. poorly) so now we are going to impart ‘truth’ on a journal – isn’t part of Science the debate process? 3)you can’t share the text if “…it is inconsistent with the weight of credible evidence or a significant number of other studies contradict the article or reference text’s conclusions” How many tests are usually conducted and reported in a peer-reviewed journal on a drugs off-label use? Finally, how many over-booked physicians are pouring over not only the latest research on new drugs but also all the literature on off-label uses vs. relying on reports from colleagues and peers about their experiences with a drug?
Yeah, “truthful” can be pretty subjective, depending on a reader’s take on things like the statistics in a paper. I hadn’t spotted that articles promoted by pharma companies essentially can’t directly contradict the body of evidence, although you’ve pointed out that it would be reasonably easy to weasel around this stipulation too.
I think your final point is particularly interesting and stems off into a whole new debate – to what degree should physicians be using their own judgment for off-label prescribing? On that note, it’s actually a pretty good idea that the FDA wants wider circulation of the evidence backing up off-label uses, it’s just a shame they’re getting the pharmaceutical industry to do it for them.
I actually got rather wrapped up in this whole pharma promotion of off-label drug uses issue and wrote a rather lengthy blog post on the topic…
That was a good article Helen. Now, let’s examine a potentially bigger problem.
For the most part FDA approved drugs are small-molecules/inhibitors. There are, obviously some biologics as well. So, based on the history of these types of drugs we know how to watch for long-term effects and toxicity. But what about stem-cells? Recently the FDA granted approval for Geron to begin a phase I clinical trial. So if we look 5-10 years the FDA will, no doubt, have to look at the potential impact of this controversial treatment in light of potential off-label uses.