The D.C. Circuit announced a new fundamental constitutional right today in Abigail Alliance for Access to Better Drugs v. Eschenbach. I assume you would like to know what your fundamental constitutional rights are, so here is the new one:
the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient.
First, some background. The FDA has a policy forbidding the sale of of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently safe for expanded human testing (Phase II of the approval process) but are not yet approved. A group of terminally ill patients wanted the FDA to permit them to use the investigational drugs even if they are risky and not approved. They sued the FDA, claiming that the the FDA’s policy violated their constitutional right to take drugs. The district court dismissed the complaint on the ground that the patients had no such constitutional right.
The D.C. Circuit reversed in a divided opinion by
Judge Bazelon Judith Rogers. The court held that that the FDA policy infringed a fundamental constitutional right and remanded to the district court to determine if the FDA’s regulatory scheme could survive strict scrutiny. As I understand the opinion, the basic reasoning of the opinion is as follows:
(1) The right to control one’s body is fundamental, Cf. Cruzan, and also implies a right to preserve oneself.
(2) If you have a right to preserve oneself, you have a right to access medications that you think you need to preserve oneself.
(3) Regulating drugs interferes with your right to access medications which you think you need to preserve yourself.
(4) Regulating drugs is a historically recent practice.
(5) The historical absence of drug regulation implies an “individual liberty deeply rooted in our Nation’s history and tradition” to be free of drug regulations.
(6) The FDA’s ban on the sale of unapproved but initially tested life-saving drugs infringes that liberty interest in the case of terminally ill patients.
(Cites to articles by Larry Tribe and Robert Post along the way, natch.) The opinion’s holding:
We conclude, upon applying the Glucksberg analysis and heeding the protected liberty interests articulated by the Supreme Court, that where there are no alternative government-approved treatment options, a terminally ill, mentally competent adult patient’s informed access to potentially life-saving investigational new drugs determined by the FDA after Phase I trials to be sufficiently safe for expanded human trials warrants protection under the Due Process Clause.
Douglas “Constitution in Exile” Ginsburg joined the majority opinion; Judge Griffith dissented. Hat tip: Howard.