- The Washington Times - Monday, May 8, 2006

Hard cases make bad law. That adage explains the concoction by a federal appeals court of a constitutional right of terminally ill patients to override the Food and Drug Administration’s dubious restrictions on the sale of new drugs in Abigail Alliance for Better Access to Developmental Drugs v. Esenbach (May 2, 2006). As Justice Benjamin Cardozo taught, the Constitution leaves room for large slabs of government folly.

Paternalism is the signature of the FDA. Generally speaking, patients are denied the opportunity to purchase drugs with a full awareness of their risks and benefits unless they have been proven both safe and effective to the FDA. The approval process typically consumes about seven years and hundreds of millions of dollars. The incentive to discover new drugs is dulled, especially for rare diseases with a small customer base. During the seven-year approval process, countless patients are foreclosed from curing or alleviating their afflictions.

The Abigail Alliance litigation emerged from the FDA’s three-phased approach to approving new drugs. Phase I tests the drugs on 20 to 80 human subjects to determine “the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.”

Drugs that survive Phase I are viewed by the FDA as safe enough for more ambitious human testing. Phase II entails controlled clinical studies of up to several hundred human subjects “to evaluate the effectiveness of the drug … and to determine [its] common short-term side effects and risks,” Phase III expanded trials involving several thousands of human subjects “gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.”

Only after the completion of Phase III is a drug eligible for FDA approval for commercial marketing, which means a seven-year wait for every new drug.

The Alliance assailed the constitutionality of the FDA’s policy barring the sale of post-Phase I investigational new drugs seemed sufficiently safe for additional human testing. The complaint alleged that the effect has been to deny terminally ill patients the choice to use the drugs despite their willingness to assume the risks if their physicians advise them that a treatment may save or prolong their lives and there are no other prospects for escaping imminent death.

The policy argument underlying the constitutional claim seems faultless. The terminally ill are naturally desperate for cures. Their risk-benefit analysis as guided by their physicians is simple and unanswerable. Without the investigative new drug, death awaits. With the drug, life may be saved or prolonged. Rational patients and their families naturally embrace hope over resignation. But the FDA insists on thwarting those hopes by purporting to save patients from their own treatment follies, a first cousin to the military policy of destroying a city to save it. Drugs are verboten until they have been conclusively proven safe and effective judged by FDA standards. If a terminally ill patient dies in the interim, the death was necessary to save the patient from imprudence.

It is one thing, however, to denounce the FDA’s callous mindlessness and to seek regulatory or statutory change by the president or Congress. The First Amendment guarantees a right to petition government to redress grievances. But it is quite another to claim a constitutional right to an enlightened government drug policy.

The U.S. Court of Appeals for the District of Columbia Circuit in Abigail Alliance discerned such a right in the Due Process Clause of the Fifth Amendment. It provides that “[n]o person shall be deprived of life, liberty, or property without due process of law.”

Despite the text’s preoccupation with procedural regularity, the Supreme Court has extended its reach to a small circle of fundamental individual rights, for example, a right to refuse life-sustaining medical treatment, but not a right to physician-assisted suicide. In Washington v. Glucksburg (1997), the court amplified that a protected fundamental right must be “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 [it] were sacrificed.”

Writing for a 2-1 panel majority in Abigail Alliance, Circuit Judge Judith Rogers reasoned that the government’s regulation of drugs did not commence until 1906, which confirmed a national tradition of non-regulation. The Circuit Judge further asserted liberty would be defiled if individuals were forbidden access to drugs or sister treatments with the aim of saving or prolonging their lives.

But there has never been an historical tradition of patient decisions trumping government health regulations. Compulsory vaccinations were sustained more than a century ago in Jacobson v. Massachusetts (1905). And the denial of the opportunity by the terminally ill to purchase drugs with at best a remote likelihood of success does not shock the conscience or provoke protest marches in the streets.

Contrary of Judge Rogers, the customary remedy for ill-conceived government regulation is better and persistent counsel, not the summoning into existence of constitutional rights by courts of law. President Bush or Congress should force the FDA to mend its ways.

Bruce Fein is a constitutional lawyer and international consultant with Bruce Fein & Associates and the Lichfield Group.

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