Sanofi has begun promoting Acomplia to doctors even though it is not yet approved by the FDA—kinda, sorta. What’s actually happening is that part of Sanofi’s diabetes sales force is briefing docs on “cardiometabolic risk, intra-abdominal adiposity and the endo-cannabinoid system.” (Those are posh med school words that mean “fat people.”)
According to a copy of a detail piece that a source kindly sent me (see download below), “increased activity of the endocannabinoid system has been shown to have an effect on: food intake, energy expenditure, and regulation of body weight.”
If only Sanofi had a drug that could regulate the endocannabinoid system. Sigh.
Oh, wait! It does! It’s called Acomplia! (Or maybe it’s called Zimulti?) Fancy that! What an amazing coincidence! According to this Sanofi press release, “Acomplia acts to decrease the overactivity of the endocannabinoid system”!
Of course, because Acomplia is not yet approved in the U.S. Sanofi sales reps aren’t allowed to mention the words “Acomplia,” “Zimulti” or “Rimonabant.” The drug goes before the FDA in June. Clearly, the Sanofites think they’ve got it right this time around, having been stalled at the FDA for some months.
The issues causing headaches for Sanofi right now: Whether the FDA will give them an indication for “obesity management,” (which likely won’t be reimbursed by insurance companies), “metabolic syndrome” (meaning a package of symptoms including intractable obesity that insurance companies would be likely to reimbuirse for), or Type 2 diabetes (which would definitely be covered).
Acomplia Report is predicting it will get obesity management only. Sanofi was expecting Acomplia to be a blockbuster, but such an unreimbursible indication would put a severe crimp on sales if patients have to pay for it themselves.
Some thoughts on pre-approval promotions: The FDA clearly prohibits companies from touting a drug that is unapproved by the FDA. But it doesn’t prohibit them from discussing diseases and conditions generally, even if the only reason they’re talking about such a disease is that they have an upcoming pill for it.
From a layperson’s perspective, then, unbranded pre-approval promotions are identical to promoting “misbranded” (to use the FDA’s technical term) unapproved drugs, with the two exceptions that the promotion takes place before, rather than after, approval and that the name of the drug is not used. Seems like its walking on the legal line ... a technical difference is not the same as an ethical one ...
Such pre-approval detailing is common, a source tells me, and indicates that the company believes it is between 6 and 2 months from receiving an “approved” letter from the feds.
Perhaps Sanofi has developed some good answers regarding concerns that Acomplia makes its users depressed and anxious.
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