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

[dps]

Got a question about this part:

Paxil was illegally promoted to patients under 18 when the drug wasn’t approved for this age group

Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients.  For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do).  So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?

Issue is the promotion by GSK for use in patients under 18. Drug companies can only market to the indications that the FDA has approved not simply whatever patients the drug company might think it appropriate for.  If the FDA doesn't grant you a juvenile indication then you can't go out and tell doctors to prescribe it for their patients under 18.  Doctors, of course, are totally still able to do so, they just can't receive information about doing so from big pharma.

Is there not a free speach issue there?

[garbon]

Is there not a free speach issue there?

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.

[DontSayBanana]

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.

[garbon]

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.

Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.

[DontSayBanana]

Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.

As long as it's got a rational basis.  Good luck defending a scrip for antidepressants to treat an infection in a malpractice suit.

[garbon]

Except that as dps helped point out, docs aren't prevented from prescribing for off-label usages as long as they can get insurance approval or patient doesn't care about such.

As long as it's got a rational basis.  Good luck defending a scrip for antidepressants to treat an infection in a malpractice suit.

Of course, off-label usages promoted by pharma companies generally aren't like that...as again, you don't make a profit in the long run if people don't actually want to keep using the drug for said use.

[stjaba]

Is there not a free speach issue there?

Commercial speech historically has been less protected than other forms of speech. There are all kinds of regulations specifically regarding pharmaceuticals- for instance banning advertising of investigational products, bans of direct to consumer ads for Schedule II drugs, drugs with "black box" warnings, etc.

However, recently the Supreme Court has began to protect commercial speech more and more. In fact, the Court has decided several First Amendment cases relating to pharmaceuticals- one case held that regulations limiting pharmacy advertisements of compounding services was unconstitutional and another case held that a law forbidding data mining of patient prescriptions was unconstitutional. I took a class on the law of medical technology this past semester and the professor predicted that a lot of these regulations could potentially be challenged based on how the Court has been going. 

[Tonitrus]

In this thread I learned: Al Capone's liability = Corporate CEO liability. 

[Neil]

In this thread I learned: Al Capone's liability = Corporate CEO liability. 

They'd never get a corporate CEO for tax evasion these days.  Their liars are too good for that.

[Ideologue]

Got a question about this part:

Paxil was illegally promoted to patients under 18 when the drug wasn't approved for this age group

Now, my understanding was that once the FDA approves a drug, doctors aren't restricted to prescribing it for a certain purpose or to a certain group of patients.  For example, a few years ago when the FDA was being asked to approve Thalidomine as a medicine to help people undergoing chemo or radiation therapy from being constantly nauseated, there were fears that if it were approved, some doctors would stupidly prescribe it to pregnant women to combat morning sickness (which was what it was originally developed to do).  So if doctors could legally prescribe Paxil to patients under 18 (even if it wasn't specifically approved for them) what's the problem?

Issue is the promotion by GSK for use in patients under 18. Drug companies can only market to the indications that the FDA has approved not simply whatever patients the drug company might think it appropriate for.  If the FDA doesn't grant you a juvenile indication then you can't go out and tell doctors to prescribe it for their patients under 18.  Doctors, of course, are totally still able to do so, they just can't receive information about doing so from big pharma.

Is there not a free speach issue there?

Commercial speech may be regulated in ways that political and artistic speech cannot.

In this case, it could either fall under deceptive speech (unprotected entirely) or, if that didn't fly, they could still uphold such regulation under Central Hudson's test, simply requiring the restriction to advance an important government interest (check) and that it be no broader than necessary (arguable, but I'll say check).

[Ideologue]

Is there not a free speach issue there?

Commercial speech historically has been less protected than other forms of speech. There are all kinds of regulations specifically regarding pharmaceuticals- for instance banning advertising of investigational products, bans of direct to consumer ads for Schedule II drugs, drugs with "black box" warnings, etc.

However, recently the Supreme Court has began to protect commercial speech more and more. In fact, the Court has decided several First Amendment cases relating to pharmaceuticals- one case held that regulations limiting pharmacy advertisements of compounding services was unconstitutional and another case held that a law forbidding data mining of patient prescriptions was unconstitutional. I took a class on the law of medical technology this past semester and the professor predicted that a lot of these regulations could potentially be challenged based on how the Court has been going.

I wonder if the Coyote Publishing case ever got to the Ninth en banc.  Nevada's brothel advertising restrictions are ripe to be struck down.

[stjaba]

In this case, it could either fall under deceptive speech (unprotected entirely) or, if that didn't fly, they could still uphold such regulation under Central Hudson's test, simply requiring the restriction to advance an important government interest (check) and that it be no broader than necessary (arguable, but I'll say check).

Regarding restrictions on advertising of pharmaceutical products, my prof's argument was that in recent cases the Supreme Court has broadly construed the no broader than necessary test, and that the Court's current preferred approach is to not restrict speech, but rather to require additional disclosures or go through non-speech alternatives, if there is no potentially misleading/false speech. 

I am basing this off my class notes from early February, so I might be missing a nuance. Now that I'm going through bar review and covering the First Amendment in depth for the first time, I get the sense he might be overreacting, but who really knows.

[Ideologue]

I haven't looked at cases directly applicable to pharma issues.  The last time I really looked in depth into it was for writing a paper on Coyote Publishing, involving brothel advertising.

In general they've really been moving toward the protection of commercial speech, though; I'd agree with your prof on that.

[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.

[garbon]

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.

Market researchers are more than trained on what is permissible and not. If they break applicable laws, I'd say throw the book at them.