Mid-Atlantic Health Law TOPICS

On May 2, 2006, a patient rights group, the Abigail Alliance for Better Access to Developmental Drugs (the Alliance), won the right to pursue its case against the Food and Drug Administration (FDA) regarding whether terminally ill patients can obtain potentially life-saving drugs when no alternative FDA-approved treatment is available. The Alliance had sued the FDA for the right of terminally ill patients to use new investigational drugs that have passed the FDA's Phase I human clinical trials, but have not completed the required Phase II and Phase III testing.

A. Background

In 2003, the Alliance submitted a proposal to the FDA for new regulations to make post-Phase I new investigational drugs available to terminally ill patients who (1) are mentally competent, (2) have a physician's support, and (3) have no other government-approved alternative. The FDA rejected the Alliance's proposal, and the Alliance sued seeking to enjoin the FDA from continuing its current policy that bars the sale of post-Phase I drugs to qualified terminally ill patients.

Phase I drug testing involves giving a drug to 20-80 persons. Drugs that pass Phase I are deemed safe for further human testing. Currently, drugs must pass two additional levels of human testing over several more years before a drug can be released to the public.

Phase II testing usually includes several hundred persons, and tests a drug's common short term side effects and risks. Expanded trials are conducted with several thousand persons in Phase III testing. That phase gathers additional safety and effectiveness information necessary to evaluate the overall benefit-risk relationship of a drug.

B. The Ruling

In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a federal appellate court reversed a lower court's dismissal of the Alliance's suit. The lower court's justification for its ruling was that a terminally ill patient does not have a constitutional right to receive medical treatment. On the other hand, the Alliance argued that, if the U.S. Constitution permits terminally ill patients to choose to withhold their own life sustaining treatment, it follows that patients in conjunction with their physicians should be permitted access to life saving post-Phase I drugs.

In a 2-1 decision, the appeals court sided with the Alliance. The appeals court stated that the Constitution's due process rights to privacy, liberty and life include the right of terminally ill patients' to self preservation. The court noted that an individual's right to control one's body, the right of self-preservation, is deeply rooted in common law and recognized throughout human history. Conversely, governmental regulation on the public's access to new drugs is relatively recent. Congress' mandate to review drugs for safety prior to commercial distribution occurred in 1938, and only in 1962 did Congress require drug manufacturers to provide empirical evidence of a drug's effectiveness.

C. The Future

The appellate court's decision in Abigail Alliance v. von Eschenbach is just an early, albeit significant, step in the course of this case. After a full airing of the issues by the trial court, one would expect further appeals. However, at the end of the day, the rules applicable to terminally ill patients' access to Phase I drugs could be significantly altered.