U.S Supreme Court Refuses to Expand Experimental-Drug Access

By Greg Stohr

Jan. 14 (Bloomberg) -- The U.S. Supreme Court turned away an appeal that sought to give terminally ill people greater access to experimental drugs that may save their lives.

The justices, without comment, rebuffed a patient-advocacy group that said the Food and Drug Administration is placing unconstitutional obstacles in the way of people who have exhausted their approved treatment options.

``Huge numbers of Americans die each year after being denied access to developmental drugs that might have prolonged their lives -- drugs that, in many instances, later received FDA marketing approval,'' argued the group, the Abigail Alliance for Better Access to Developmental Drugs.

The Bush administration and the FDA urged the court not to hear the case, saying the appeal sought to ``revive a brand of judicial intervention that this court foreswore long ago.''

The case involved people who aren't included in the clinical trials conducted by pharmaceutical companies or the expanded access programs that drugmakers offer for some experimental treatments.

Under federal law, people who aren't in those groups and want access to experimental treatments must persuade the FDA that the benefits outweigh the risks, a process that requires what Abigail Alliance calls a ``mountain of regulatory paperwork.''

70 Per Year

As a practical matter, those patients also must get the support of the drug company, according to Scott Ballenger, a Washington lawyer representing the Abigail Alliance. He said that only about 70 patients a year successfully navigate the process.

The administration told the court that ``nearly all'' individual patient applications are approved.

The Abigail Alliance is named after Abigail Burroughs, who died in 2001 at age 21 after an 18-month battle with head and neck cancer. In the months before Abigail died, her family unsuccessfully sought access to Erbitux, an ImClone Systems Inc. cancer drug that was undergoing clinical testing and had been recommended by her oncologist. The FDA approved the drug in 2004.

Abigail's father, Frank Burroughs, is president of the Charlottesville, Virginia, group.

A federal appeals court in Washington ruled against the patient group in August on an 8-2 vote.

``There is no fundamental right `deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill,'' the majority said, quoting from a 1997 Supreme Court case concerning doctor-assisted suicide.

Phases of Testing

The appeal focused on drugs that are in the second and third phases of testing required under FDA rules. Phase 2 testing can involve several hundred patients, while Phase 3 testing often includes several thousand subjects.

The drugs are ``safe and promising enough to be tested in substantial numbers of human subjects,'' the appeal argued.

The administration argued that a so-called investigational drug ``may be wholly ineffective'' and that ``taking it may sicken the patient or even kill him.''

The government also said wider disbursement of investigational medicines might undermine clinical testing. That would especially be the case if drugmakers could sell those products at a profit -- something they currently can't do -- because companies would have less incentive to pursue regulatory approval, the U.S. said.

The case is Abigail Alliance v. Von Eschenbach, 07-144.

To contact the reporter on this story: Greg Stohr in Washington at gstohr@bloomberg.net .

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