Here’s one for King Solomon:

On March, the U.S. Court of Appeals in Washington, D.C., will try to decide whether dying patients have a constitutional right to purchase unapproved experimental drugs that have completed Phase I human testing if their doctors say there are no other viable options. Last May, a three-judge panel ruled patients have this right.

The debate throws into question the extent to which regulators should allow unapproved meds to be prescribed without the sort of testing usually required, according to The Star-Ledger of New Jersey (which runs Pharmalot, by the way).

The FDA is vigorously contesting what it calls “a profoundly troubling ruling,” arguing the appeals court has placed its ability to ensure patient safety in “a constitutional straight jacket.” Ironically, the FDA is weathering tremendous criticism over its ability and willingness to protect patient safety and scrutinize drugs correctly.

The Washington Legal Foundation, which is arguing the case on behalf of the Abigail Alliance, a non-profit founded to press the cause, says the FDA policy is restrictive and arbitrary.

Peter Jacobson of the University of Michigan Center for Law, Ethics and Health frames the case nicely when he says it presents a classic conflict between individual rights and the broader needs of society.

“Do I want to be the doctor telling a dying patient he has nothing to offer? No. Do I want to be the regulator saying you are not eligible for compassionate use of an experimental drug? No,” said Jacobson “But if I am a regulator and I say you can have anything you want, how do I protect patient safety?”

What do you think?

[tags]Abigail Alliance, Experimental Drugs, FDA[/tags]