Private attorneys Mark Hermann and Jim Beck have an extensive post at the Drug and Device Law blog discussing some of the practical implications of the Abigail Alliance litigation. Among other things, their post helps explain why drug manufacturers did not support the Alliance's claims. Here's a taste of their comments:
The recognition of a constitutional right of access to entirely unapproved drugs would create a Catch-22 legal environment where, on the one hand a company definitely should provide warnings – if only to protect itself from liability – but the law absolutely forbids giving them.
Plainly, in addressing the claim of a broad, vague new constitutional right, neither side in Abigail Alliance gave much thought to the practicalities of the situation. In order to satisfy that right, would the manufacturer of an experimental drug be forever locked into providing it, even after it had decided not to proceed with commercialization? FDA good manufacturing practices are pretty strict. Unless manufacturing is turned over to some fly-by-night foreign operation (which nobody advocates), to keep a production process going for a minuscule population claiming constitutional entitlement is not a cheap proposition. So from a purely monetary standpoint, we’re pleased that no new constitutional right is going to interfere with our clients’ ability to allocate their limited resources available for research in favor of those drugs in the pipeline that appear to have the most promise.
Isn’t that putting the crass commercial interests of drug companies ahead of the needs of desperately ill people? Well, if it is, then we’re in good company – eight of ten DC circuit court judges agree with us. Not bad for a couple of tort lawyers whose only real familiarity with constitutional law is limited to preemption and the First Amendment.
Further, we don’t think so, for two reasons: (1) forcing an uneconomic reallocation of research dollars will ultimately result in fewer FDA approvable “safe and effective” drugs being discovered, something that would wind up hurting many more people than a few unapproved drugs could possibly help; and (2) creating an uncertain, litigation-charged environment around experimental drugs that might cure fatal diseases would have any number of unintended consequences – from making enrollment in clinical trials more difficult, to driving the conduct of such trials out of the country altogether.
Nor does it hurt that we’re defense lawyers, and this kind of pejorative rhetoric is something we’ve had thrown at us in practically every case we have to defend.
All of this is why, in the end, we think that notwithstanding some questionable reasoning, the court got it right. These plaintiffs, like so many others, have fallen prey to judicial triumphalism – the notion that litigation and court decisions are the best way to solve any and all societal problems. The solution isn’t for courts to create another undefined constitutional right enforceable through amorphous litigation. Rather, Congress should legislate, and the FDA should regulate to create an environment in which experimental drugs can be available for terminally ill patients under rational and economically sensible criteria, and in which drug companies can provide such drugs without the risk of being sued or being subject to administrative sanction.
Hermann and Beck also suggest that a recognition of a constitutional right to experimental drugs would lead to lawsuits against drug manufacturers from terminally ill patients demanding access to experimental drugs. While I have no doubt such cases would be filed — and they cite examples of such cases that have already been brought — I also have little doubt that drug manufacturers would prevail in such suits. Drug companies are not state actors. Legal recognition of a constitutional right that limits the government's ability to deny access to certain drugs does not create any affirmative obligations on drug manufacturers. I certainly understand why drug manufacturers would be wary of such suits — after all, even suits with little merit can be costly to defend against — I just don't think such suits would ever be successful.
UPDATE: I mistakenly attributed the post at Drug and Device Law blog to only one of the blog's two contributors, when it should have been attributed to both of them. I've corrected the error.
Related Posts (on one page):
- Abigail Alliance and therapeutic cloning
- Abigail Alliance -- The Practitioners Respond:
- Roger Pilon on Abigail Alliance:
- A Practitioner's Perspective on Abigail Alliance:
- More on Abigail Alliance:
- Judge Rogers' Abigail Alliance Dissent:
- Jessie Hill on Abigail Alliance:
- Some Thoughts on Abigail Alliance:
- No Constitutional Right to Drugs:
I was all set to respond until I read that last paragraph. But that pretty much sums it up. Of course, it all shows why the whole argument preceding it is complete non-sense. Aside from giving a defense attorney the chance to bitch about a completely fictitious litigation problem, I don't really see the point.
Keeping an FDA around in the first place results in "fewer FDA approvable 'safe and effective' drugs being discovered," in any case. If you heavily restrict an activity, you'll get less of it.
Yes, TSW, the quoted post is a big fat straw man.
The fact that the government can't kill you by denying you the right to purchase a drug from a willing seller doesn't mean that you can force the drug seller to give you the drug.
Recognizing a constitutional right to access life saving drugs would no more lead to lawsuits against drug-makers than recognizing a constitutional right to free speech would lead to lawsuits against sellers of pens, ink, paper, and bullhorns.
The fact that the constitution protects doctors' speech about off-label uses of drugs hasn't led to patients suing doctors to force them to provide such information.
By contrast, their criticism of the reasoning and claims underlying the majority opinion (such as its ludicrous claim that FDA reflects the collective judgments of the scientific and medical communities) is quite apt.
Isn't cart ahead of the donkey?
Where is the authority given to the Federal government to prohibit access to a [experimantal] produt that a company is willing to make available to the the unlucky few?
It is the Federal government, through the FDA, that is taking an active role to deny something. The case is not a about making the requirement that an experimental product that may work be provided.
This is why I wonder whether the SCOTUS ever read the Constitution. Where is the application of the 9th and 10th amendments?
My 1st amendment rights oes not create a requirement on anybody to suply me with a printer.
I see no valid reason for any court to deny those remedies.
That is: a drug is approved, but has too small a market for the patent holder to produce profitably, but some peoples' lives or well being depend on it.
If a drug is either approved and unprofitable, or just unapproved, but peoples' lives and wellbeing depend on it, then the patent holder is in basically the same position.
Seems to me that if the patent holder in such a circumstance plays dog in the manger with patent licensing, then they really ARE the bad guys.
If it's not profitable to produce, or not approved, and somebody needs it to stay alive, then I can't think of any reason but craven nastitude for the patent owner not to allow a willing producer to produce it.
That the government itself prohibits access in the free market to lifesaving drugs just because some bureaucrats don't think the drugs are effective is evidence that the government isn't currently fit to govern in that arena.
Producing pharmaceuticals is actually fairly inexpensive; the real costs are in development and litigation. I doubt that there are very many, if any, approved drugs that have gone out of production despite being useful.
SFB