Since the beginning of 2014, five states that we know of have enacted what is called “Right to Try” statutes.  See Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§16221, 26451; V.A. Mo. S. §191.480.  “Right to Try” (a play on right to die) legislation addresses a serious subject as to which there is no easy answer.  There are still a lot of incurable diseases out there.  When somebody is afflicted with such a disease, all established treatments have failed, and that person is facing certain death, can that person have access to unapproved drugs – those that are still “investigational”  in FDA parlance – on the theory that s/he has nothing to lose?

We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007.  For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs.  Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).

We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought.  Sure enough, that’s happened, too, even without the purported constitutional right.  We discussed a number of such cases (all, thankfully unsuccessful) here.


Continue Reading

On a number of occasions – more during the first couple of years of the blog than recently – we opposed causes of action that would impose liability on drug/device manufacturers for investigational drugs that worked, and indeed worked well. By that we mean claims by research subjects demanding one form or another of continued

We’re thinking about the recent Abigail Alliance case again. As readers of this blog know, the en banc D.C. Circuit held on August 7 that terminally ill patients do not have a constitutional right to take unapproved drugs in the hope of a cure.

We did a short post on that topic, which the Volokh

We’re taking it on the chin in the “comments” over at the Volokh Conspiracy. Jonathan Adler linked to our post yesterday about the Abigail Alliance case, and the scholars are lining up to say that pharmaceutical companies are not “state actors” and so would never be compelled to provide experimental drugs to terminally ill patients.