Reply to "New Developments in Treatment: Erbitux® (cetuximab)"

Appeals court upholds stringent FDA regulation of experimental drugs.

The U.S. Court of Appeals for the District of Columbia Circuit has ruled 8-2 that terminally ill patients do not have a constitutional
right to access drugs that have passed preliminary safety tests and are now in FDA-approved clinical trials. Rather, the court ruled that safety is still an important issue and that the legislative branch of our government is better suited than the courts to decide the proper balance between the uncertain risks and benefits of medical technology. The ruling by the full court reversed an earlier 2-1
decision in favor of the Washington Legal Foundation (WLF) and its client, the Abigail Alliance for Better Access to Developmental
Drugs, an organization that seeks expanded access to experimental drugs for the terminally ill. WLF plans to appeal to the U.S. Supreme
Court. The case documents are archived at http://www.wlf.org/Litigating/casedetail.asp?detail=266&printIt=1
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