Is there really criminal activity at this company? Or aggressive sales/marketing/promotions tactics that may be borderline unethical but not illegal?
This is an interesting question. You are asking, "Has a crime been committed"? To my knowledge, nothing meeting the definition of
criminal has occurred. Crimes are by definition against the law. That is, they are illegal. I think what's happening at Vanda is more closely related to
illicit.This tends to encompass things that are forbidden or disapproved of by custom or society. Or, immoral and unethical, but those are individual interpretations. At the heart of your question is this: Is something legal because it has not been deemed illegal?
In the case of Hetlioz, because the indication doesn't limit it's use to the blind patient exclusively, then all patients are fair game. . . despite
zero evidence tasimelteon was deemed safe and effective in this population. That is not illegal and marketing Hetlioz as such isn't "off label" because the label doesn't limit its use to the blind. Again, we can do this because the label doesn't say we can't. There is a difference between marketing specifically to the indication to expand the potential patient base and using the indication to restrict the patient base. Fanapt is
limited to schizophrenia which describes a specific patients diagnosis whereas Hetlioz is being marketed to non-24 which is being used to
expand the patient diagnosis with vague definitions and "fuzzy" patient clinical presentation.
There was an earlier post with several links describing the submissions by Vanda to the FDA around Hetlioz. And the subsequent replies by the FDA leading up to the ultimate approval of tasimelteon with the approved indication being, "non-24 circadian rhythm sleep disturbance in totally blind individuals with limited light perception". That indication was changed by the FDA
after the fact where any reference to blind individuals was removed. Even though 100% of the safety and efficacy information submitted to the FDA was from clinical trials conducted in blind patients.
So to answer your question - no, there hasn't been a crime that I'm aware of. Has there been fraud which certainly is a crime? That's up to the defrauded to establish; ie the patients payer. I do believe there are questionable messages being delivered by some of the field in order to generate intakes. And because the company sees only the results and doesn't question the process, they have given their tacit approval to the methods used by those individuals.
Ultimately the FDA/OIG would have to investigate once a complaint has been made. But of course there's very little paper trail.
Crime - no. Questionable, unethical, immoral, icky, I need a shower at the end of each day, can't get out of here fast enough? Absolutely!!