An appeals court in the United States has ruled that terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators.
The ruling was the result of a case brought before the court by two advocacy groups, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation.
The duo sued the FDA for greater access for dying patients to unapproved medicines that have cleared early safety tests. which usually include 20 to 80 people.
They argued that patients have a constitutional right to try experimental drugs that have passed that hurdle, if they so choose.
Before granting approval for new drugs the U.S. Food and Drug Administration (FDA) demands comprehensive research is conducted both in the laboratory and on animals before advanced trials with people are carried out.
This process means that it can take up to 10 years before a new drug is approved.
The U.S. Court of Appeals for the District of Columbia reversed a May 2006 ruling by a divided three-judge appeals panel, which overturned a 2004 district court decision to throw out the case, by an 8-2 decision.
Judge Thomas Griffith said the FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.
The Abigail Alliance and the Washington Legal Foundation now plan to take their appeal to the Supreme Court and say they are saddened by the decision.
They say every drug the group has sought early access to over the past six years was eventually approved by the FDA.
Though some patients are offered experimental drugs as part of a clinical trial or other programs, many patients are excluded and the FDA did propose new rules in December 2006 to help more seriously ill patients gain access.
The Washington Legal Foundation has a long history of challenging FDA regulations and policies that restrict patients' right to life-saving drugs.
The Abigail Alliance, was founded in 2001 by Frank Burroughs whose daughter, Abigail, died of cancer in 2001 because she was denied access to drugs that her oncologist believed could save or prolong her life.