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Court Blocks Early Access to Experimental Treatments (Update2)

By Erik Larson

Aug. 7 (Bloomberg) -- A U.S. appeals court ruled that terminally ill patients don't have a constitutional right to use experimental drugs that have passed limited safety trials but haven't been proved safe and effective.

A fundamental right to use drugs under development can't be established because such access isn't ``deeply rooted'' in U.S. history and tradition, according to the 8-2 ruling issued today by a panel of judges on the Court of Appeals in Washington, D.C.

The courts ``cannot justify creating a constitutional right to assume any level of risk, without regard to the scientific and medical judgment expressed through the clinical testing process,'' the judges wrote in the 65-page opinion, affirming a lower court ruling.

The finding was a setback for the Abigail Alliance for Better Access to Developmental Drugs, an interest group that sued the Food and Drug Administration four years ago. The Alliance wants to make experimental medicines available to terminally ill patients during the ``extremely lengthy'' drug-approval process, which can last around seven years, according to court papers.

``The Abigail Alliance is dumbfounded that most of the justices tragically missed the merits of the case,'' Frank Burroughs, president of the Abigail Alliance, said in a telephone interview. ``We are going to appeal to the Supreme Court.''

The FDA is pleased with the court's decision because it ``upholds the constitutionality of the FDA's role,'' spokeswoman Susan Cruzan said in an e-mailed statement.


While the FDA facilitates ``appropriate treatment access to investigational therapies'' it also requires that drugs are ``proven to be safe and effective'' before being marketed to U.S. consumers, Cruzan said.

The FDA proposed in December a regulatory change that would make experimental drugs more widely and easily available to seriously ill patients with no other treatment options. The agency is reviewing comments on the proposal and doesn't have a specific time for issuing a final rule, Cruzan said.

The Alliance argued that access to experimental drugs was backed by ``traditional self-defense principles'' and the tort of intentional interference with lifesaving efforts. The court rejected those arguments, saying they aren't in step with current regulatory trends.

``The Alliance's argument ignores our nation's history of drug-safety regulation,'' the justices wrote, adding that risks associated with drugs have become clearer and the government's ability to address them has increased.

Erbitux, Gleevec

The Alliance has pushed during the past six years for early access to 16 drugs for cancer and other life-threatening illnesses, according to Burroughs. Each drug eventually won FDA approval, including ImClone Systems Inc.'s colon cancer drug Erbitux, Novartis AG's leukemia medicine Gleevec and Bayer AG's kidney cancer treatment Nexavar.

``There isn't one drug we've pushed for that has been rejected by the FDA,'' Burroughs said. He said more than 1.6 million people could have benefited from the drugs during the campaign.

``The FDA and Congress get on the safety issue soap box, and they forget about the people who have a very different risk- benefit perspective,'' Burroughs said.

The case is Abigail Alliance for Better Access to Developmental Drugs, et al v. U.S. Food and Drug Administration, et al, case number 04-5350, in the U.S. Court of Appeals for the D.C. Circuit.

To contact the reporter on this story: Erik Larson in New York at elarson4@bloomberg.net .

Last Updated: August 7, 2007 17:45 EDT

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