U.S. court rejects appeal seeking unapproved drugs

WASHINGTON Mon Jan 14, 2008 12:43pm EST

Storm clouds gather over the U.S. Supreme Court building in Washington, June 27, 2005. REUTERS/Jonathan Ernst

Storm clouds gather over the U.S. Supreme Court building in Washington, June 27, 2005.

Credit: Reuters/Jonathan Ernst

WASHINGTON (Reuters) - The U.S. Supreme Court rejected an appeal on Monday by two advocacy groups arguing that dying patients have a constitutional right to access experimental drugs that have not received regulatory approval.

The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the U.S. Food and Drug Administration in 2003 seeking greater access for terminally ill patients to medicines that have cleared early, limited safety tests, but have yet to be approved.

The lawsuit argued that the FDA's policy to withhold early-stage experimental drugs from terminally ill patients violates the Constitution by depriving them of life and liberty without due process.

Without any comment or recorded dissent, the justices refused to review a U.S. appeals court ruling in August that there is no fundamental constitutional right of access to experimental drugs for the terminally ill.

The FDA requires a wide battery of tests, ranging from animal and laboratory tests to advanced trials with people, before it will consider approving a new drug. Manufacturers say the process can take up to 10 years.

J. Scott Ballenger, an attorney for the two advocacy groups, said in the Supreme Court appeal that the case presented an issue of great national importance, especially to terminally ill patients and their families.

"Approximately half a million Americans will die this year of cancer alone and a substantial proportion will find themselves at some point without any remaining treatment alternatives," he said.

The two advocacy groups only seek the right for dying patients to take a drug their doctors have concluded is justified by the available scientific evidence and is undergoing clinical trials involving a relatively small group of people, Ballenger said.

The Bush administration urged the Supreme Court to reject the appeal. It said the FDA proposed new rules in December 2006 that would help more seriously ill patients gain access to experimental drugs.

Solicitor General Paul Clement said allowing patients to use unproven drugs would involve a host of risks and potential harm for the public health.

"An investigational drug that appears promising to a patient or his physician may in fact be wholly ineffective. Worse still, the drug may be affirmatively unsafe and taking it may sicken the patient or even kill him," Clement said.

(Editing by Philip Barbara)

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