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.