A Practitioner's Perspective on Abigail Alliance:

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.