Judge Judith Rogers, writing for a three-judge panel of the Circuit Court of Appeals for the District of Columbia in Abigail Alliance for Access to Better Drugs v. Eschenbach, upheld
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. . . .
and even where that medication has not been approved for release by the Food and Drug Administration. Mike at Crime & Federalism summarizes the issue at hand:
The plaintiffs in Abigail Alliance for Access to Better Drugs v. Eschenbach were terminally-ill patients who were denied potentially life-saving drugs. They successfully argued that the Due Process Clause of the Constitution clearly protects the right to "life," and that the FDA was denying them the right to life by refusing to allow them to ingest drugs that would save them.
Here's more from Judge Rogers's opinion:
[t]he Due Process Clause of the Fifth Amendment to the United States Constitution provides that “[n]o person shall be . . . deprived of life, liberty, or property, without due process of law.” U.S. CONST. AMEND. V. The Supreme Court has held that the Clause “guarantees more than fair process” and accords substantive protection to the rights it guarantees. . . .
For over half of our Nation’s history, then, until the enactment of the 1906 [Pure Food and Drug] Act, a person could obtain access to any new drug without any government interference whatsoever. Even after enactment of the FDCA [Food, Drug, and Cosmetic Act] in 1938, Congress imposed no limitation on the commercial marketing of new drugs based upon the drugs’ effectiveness. Rather, at that time, the FDA [Food and Drug Administration] could only interrupt the sale of new drugs based on its determination that a new drug was unsafe. Government regulation of drugs premised on concern over a new drug’s efficacy, as opposed to its safety, is of recent origin. And even today, a patient may use a drug for unapproved purposes even where the drug may be unsafe or ineffective for the off-label purpose. Despite the FDA’s claims to the contrary, therefore, it cannot be said that government control of access to potentially life-saving medication “is now firmly ingrained in our understanding of the appropriate role of government,” . . . so as to overturn the long-standing tradition of the right of self-preservation. . . .
The prerogative asserted by the FDA — to prevent a terminally ill patient from using potentially life-saving medication to which those in Phase II clinical trials have access — thus impinges upon an individual liberty deeply rooted in our Nation’s history and tradition of self-preservation.
Judge Rogers's opinion (in which Chief Judge Douglas Ginsburg joined) may not withstand a hearing by the full Circuit, but if it does . . . welcome back Lochner. Lochner v. New York is the 1905 case in which the Supreme Court struck down a State statute that attempted to impose a maximum-hours limitation on bakers. Lochner is a bête noire to liberals because it triggered a wave of Supreme Court decisions deemed "pro-business" (as if business were an enemy). But Lochner and its offspring were decided rightly because they upheld, as a matter of due process, the Constitution's explicit guarantee of liberty of contract.
Substantive due process does not grant a right to anything (e.g., a job). Rather, it protects one's life, liberty, and property as long as one is engaged in voluntary, consensual conduct that does not harm others (e.g., running a business without being entangled in regulations or extorted by government-approved labor unions). Judge Rogers's opinion gives me hope for the return of substantive due process in its proper, Lochnerian form.
Related posts:
Substantive Due Process, Liberty of Contract, and States' Police Power
Where's Substantive Due Process When You Need It?
