- The Washington Times - Tuesday, August 14, 2007

The case of Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach (Aug. 7) pitted regulatory folly against judicial whimsy. There, the United States Court of Appeals for the District of Columbia Circuit rejected a constitutional claim by terminally ill patients of access to unapproved new drugs regulated by the federal Food and Drug Administration. The litigation corroborates German Chancellor Konrad Adenauer’s lament that while God placed sharp limits on man’s intelligence, the deity placed no corresponding boundaries on man’s foolishness.

It was born from a characteristically paternalist and undiscriminating regulatory mentality. In 1938, Congress enacted the Federal Food, Drug, and Cosmetic Act as an answer to more than 100 deaths from ingesting Elixir Sulfanilamide, which had been marketed as an antibiotic. The act required drug manufacturers to test and the Food and Drug Administration (FDA) to review all new drugs for safety before their commercial distribution. Then came the thalidomide babies, i.e., the rash of birth defective infants whose mothers had taken the drug to alleviate morning sickness. Congress responded with the Kefauver-Harris Amendments. It obligates manufacturers to prove evidence of a drug’s effectiveness to the FDA through well-controlled investigations as a condition of marketing.

At present, the safety and efficacy testing process for new drugs consumes an average of seven years and the dollar expenditure of hundreds of millions. That means denying patients access to drugs for long years that ultimately prove medically effective. Moreover, the time and expense of FDA approval means that drug companies will forgo attempts to treat rare diseases because the potential consumer market would be too narrow to justify the regulatory costs. In sum, the act forces certain categories of patients to endure suffering as the price of forestalling the sale of unsafe or ineffective drugs to consumers generally. No second editions of thalidomide babies.

But the act is patently obtuse when taken to extremes. A non-trivial number of terminally ill patients might survive with access to a pioneering drug that has yet to clear the FDA’s regulatory hurdles. It seems both mindless and cruel for the FDA to block their access to a drug that carries the sole hope of life, first cousin to forbidding a rescue attempt for a hostage threatened with imminent death.

In response to that concern, Congress and the FDA have created tightly circumscribed programs for early access to new drugs to treat “serious or immediately life-threatening disease.” One program makes an exception if there are no comparable therapies; the drug is under investigation in a controlled clinical trial; and, the drug sponsor is actively pursing safety and effectiveness approval. The FDA, however, may still deny an exception if the agency doubts the drug’s effectiveness or worries that the drug would expose the dying patient to an unreasonable additional risk of illness or injury. Further, sponsors of excepted drugs are precluded from profiting from sales, which dulls their incentive to participate.

The Aristotelian mean dictates an alternative to the FDA’s callousness towards the terminally ill. They should enjoy access to any drug recommended by physicians to treat their afflictions, but only after receiving a comprehensive tutorial explaining the safety risks and probability of success. Absolute patient-physician autonomy should prevail in seeking to save lives just as it does under Oregon’s law for physician-assisted compassionate dying.

An organization of terminally ill patients (the “Alliance“) brought suit insisting that the United States Constitution required the FDA to embrace the Aristotelian mean. The Alliance argued that the Fifth Amendment’s protection against the deprivation of life or liberty without due process of law created an unenumerated right to be free of government obstructions to potentially life-saving drugs. In a series of countertextual and Delphic interpretations culminating in Washington v. Glucksburg (1997), the Supreme Court has declared that the “Due Process Clause specially protects those fundamental rights and liberties which are, objectively, deeply rooted in this Nation’s history and tradition and implicit in the concept of ordered liberty, such that neither liberty nor justice would exist if they were sacrificed.”

The Glucksburg standard is sheer nonsense. If a right had been acclaimed by history and tradition as the crown jewel of liberty and justice, it would need no judicial protection. No legislator or regulator would dare to act in opposition. In addition, a few seconds of argument before Supreme Court Justices or law school professors discredits the idea of a consensus over rights said to be the sine qua non of liberty and justice, for example, same-sex marriage, homosexual sodomy or abortion.

In Abigail Alliance, 10 circuit judges surveyed the nation’s history and tradition in regulating the medical options of terminally ill patients. Eight discerned no fundamental right of access to unapproved drugs in furtherance of life. Two discerned the opposite. Both conclusions were plausible under Glucksburg.

The intersection of regulatory inflexibility and judicial caprice in the case left an unsatisfying feeling-like wishing a plague on both houses.

Bruce Fein is a constitutional lawyer with Bruce Fein & Associates and chairman of the American Freedom Agenda.