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Determining Patient Access to Investigational Drugs in the US

November 2007

RAJ Pharma
Terminally ill patients do not have a constitutional right to obtain early-stage investigational drugs in the US. In 2003, the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs challenged the refusal of the Food and Drug Administration to allow such patients access to all available treatment. The suit failed but was reversed by an appeals court panel in May 2006. However, on 7 August 2007, the US Court of Appeals for the District of Columbia Circuit issued an opinion in Abigail Alliance for Better Access to Developmental Drugs v von Eschenbach, upholding the original 2003 decision. Although important, this opinion does not bring the public policy debate to a close.


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