A COURT MAKES UP A RIGHT

The Founding Fathers and the FDA

The U.S. Court of Appeals for the D.C. Circuit discovered a new
constitutional right yesterday: "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 has not been
approved by the Food and Drug Administration. If you don't remember
reading those particular words in the founding charter, don't kick yourself.

An ideologically eclectic panel of the normally sober D.C. Circuit
pulled this "right" out of thin air. If the full court, or the
Supreme Court, doesn't take another look, it could sow the seeds of
all kinds of mischief.

We're sympathetic to the plight of desperately ill people who may --
or may not -- be helped by experimental drugs that are just beyond
their reach. Regulators and drug companies have taken some steps to
address their need, and there may be more they can do to make
unapproved therapies available to people ineligible to participate in
clinical trials.

But since when did access to experimental therapies become a
"fundamental right" -- defined in Supreme Court case law as a right
deeply embedded in the fabric of American tradition and without which
ordered liberty would not be meaningfully free? To root this right in
tradition, the majority opinion -- written by the relatively liberal
Judge Judith W. Rogers for herself and conservative Chief Judge
Douglas H. Ginsburg -- cites the age-old right of "personal
security," along with the fact that "the government has not blocked
access to new drugs throughout the greater part of our Nation's
history" and the notion that "an individual has a . . . right to
refuse life-sustaining medical treatment." The flip side of this
principle, the majority argues, must be "the right to access
potentially life-sustaining medication where there are no alternative
government-approved treatment options."

All of which, as newly appointed Judge Thomas B. Griffith argued in
dissent, is a lot of hooey.

The decision not to regulate an area over a long period of time does
not create a right to be free of regulation in that area. As Judge
Griffith wrote, "a tradition protecting individual freedom from
life-saving, but forced, medical treatment does not evidence a
constitutional tradition of providing affirmative access to a
potentially harmful, and even fatal, commercial good." If this right
is real, it potentially calls into question the whole fabric of drug
regulation. Why do only terminally ill patients have it? Why doesn't
an itchy eczema victim have a right to some new cream?

Does the government have an obligation to fund the right for
indigents who cannot afford access on their own? For that matter, why
does the right only apply to drugs that have passed Phase I testing
- -- that is, preliminary safety trials?

Why, in other words, doesn't the principle the court embraces create
a right to LSD or marijuana, for which people have made all kinds of
extraordinary medical claims?

In creating the legal regime that governs drug approvals, Congress
left the decision of when to permit drugs to go to market to the FDA.
The FDA's balancing of the competing interests of patients, public
health and science may not be perfect.

But the cure does not reside in the Constitution.