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Access to experimental drugs isn't a protected right, but the FDA should find a way to broaden availability.

August 13, 2007

It's a poignant predicament for a gravely ill person: An experimental drug exists that might promote recovery or postpone death, but it hasn't received final approval from the Food and Drug Administration.

Advocates for the seriously ill argue persuasively that the FDA should allow wider use of drugs and other therapies that have received preliminary approval or are the subjects of trials. But a federal appeals court rightly has rejected the much more sweeping argument that the Constitution confers a right to make use of such drugs.

By an 8-2 vote, the U.S. Court of Appeals for the District of Columbia last week overturned a three-judge panel's ruling that a terminally ill, mentally competent adult has a constitutional right to "potentially life-saving investigational new drugs" that seem to be safe for humans though not necessarily effective. Writing for the court, Judge Thomas Griffith said access to experimental drugs for the terminally ill is not a right "deeply rooted in our nation's history and tradition."

The "deeply rooted" formula is used by the Supreme Court to decide whether certain rights not specifically mentioned in the Constitution are nevertheless protected by the document's guarantees that individuals won't be deprived of life, liberty or property without due process of law. The high court has found that some rights -- freedom to marry, for example -- are so basic that no legal process exists by which they could be forfeited.

In deciding what qualifies as an "unenumerated" constitutional right, the courts look to history and tradition. Judges disagree in particular cases about both the existence of such rights and how far they extend. (The most controversial example of an unenumerated right is the right to privacy articulated in the Supreme Court's abortion cases.) Even so, it's not surprising that both liberal and conservative members of the appeals court agreed with Griffith.

That said, the group that brought this lawsuit -- the Abigail Alliance for Better Access to Developmental Drugs -- makes a policy argument that the FDA could be less parsimonious with the provision of drugs to the terminally ill.

In his opinion, Griffith noted that the agency already may approve the use of investigational drugs for patients with life-threatening diseases if they aren't eligible for clinical trials. The FDA should consider making such dispensations easier to obtain, even if it means that patients who availed themselves of the drugs give up some legal rights. The agency also should take a fresh look at whether new drugs can be evaluated only by "randomized" tests in which some patients receive the drug and others a placebo -- a protocol that discourages the wider dissemination of investigational drugs.

These are matters of life and death, but they are matters of policy, not constitutional law.

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