Tuesday 15 January, 2008

U.S Supreme court reject appeal on experimental drugs access

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 USFDA 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.''

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