GlaxoSmithKline Pleads Guilty To Illegal Drug Marketing; Fined $3 Billion

[Capetan Mihali]

I'm not a lawtalker so I don't know but I'd guess concerns about undue influence from pharmaceuticals (potentially in ways that actually harm patients - although pharmas would lose in the long run if they promote harmful off-label usages) has been found to be a trumping issue.

Prescription drugs are on most, if not all, states' schedules of restricted substances- since possessing a prescription drug without a valid prescription is a misdemeanor at least, the state has an interest in controlling distribution of those substances.

Antidepressants and antibiotics are Rx-only, but they aren't scheduled.

[dps]

Okay, then perhaps we should just arrest people in marketing.  Or Marketing Research or whatever.

Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.

The knowledge that you are breaking the law is not necessary to be criminally liable.

Ignorance of the law is not a defense, but ignorance of fact is.

[Martinus]

Okay, then perhaps we should just arrest people in marketing.  Or Marketing Research or whatever.

Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.

The knowledge that you are breaking the law is not necessary to be criminally liable.

Ignorance of the law is not a defense, but ignorance of fact is.

Ignorance of fact *may* be a defense but does not have to be. It's only a defense if the ignorance is justified (so is not a result of negligence for example).

[Malthus]

As garbon has pointed out, the issue is that phyiscians are not restricted by law as to what they can prescribe drugs for - in that they can prescribe "off label" (leaving aside liability concens). On the other hand, manufacturers cannot "promote" drugs for off-label uses. Yet it takes years and millions of dollars for manufacturers to have a drug indication approved.

This creates an obvious incentive, when a hot new use for a drug is discovered, to promote "off label" to physicians.

The lines are not at all clear-cut, as some types of "off label" promotion to docs is not only allowed, but is required. For example, in order to get a new indication, manufacturers must do clinical testing, which requires recruiting docs and patients for clinical trials ... to generate scientific debate about drugs, it is necessary to hold scientific conferences ... all of which can potentially be used (or abused) to promote "off label" to physicians. Hence a proliferation of rules concering these activities (not nearly as elaborate in Canada as in the US, btw).

[dps]

Okay, then perhaps we should just arrest people in marketing.  Or Marketing Research or whatever.

Maybe, I mean said marketers and sales personnel are the ones knowingly breaking the law. You'd probably be hard pressed to attribute such to a market researcher unless I guess they prepared a research report that advocated adopting the promotion of off-label uses.

The knowledge that you are breaking the law is not necessary to be criminally liable.

Ignorance of the law is not a defense, but ignorance of fact is.

Ignorance of fact *may* be a defense but does not have to be. It's only a defense if the ignorance is justified (so is not a result of negligence for example).

Yes, it's not an absolute defense.

[Barrister]

Yes, it's not an absolute defense.

"Ignorance of fact" is not only not an absolute defence, it really can't be characterized as a defence at all.  It depends entirely on the situation.  You can be convicted of stealing property that turned out to be your own, if you intended to steal someone else's property.  Or you can be acquitted of stealing property if you had reasonable grounds to believe it was already your own.