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The Abigail Alliance Case: A Different Legal Challenge

doi: 10.1097/01.NT.0000337677.15055.11
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Frank Burroughs established the Abigail Alliance for Experimental Access to Drugs in November 2001 after his daughter, Abigail, a college student who had head and neck cancer, died. She had been denied access to the experimental cancer drug cetuximab (Erbitrux), which was only available at the time through clinical trials for patients with colon cancer.

In 2003, the Alliance sued the FDA for access to unapproved drugs, lost the case, and appealed it in May 2006. But the appeal was turned over a year later, and the Alliance vowed to take the case to the Supreme Court. In January of this year, the court declined to accept the case, which left existing FDA regulations intact.

The Abigail Alliance is advocating for the passage of the Access, Compassion, Care, and Ethics for Seriously Ill Patients(ACCESS) Act, introduced in Congress in May and co-sponsored by Congresswoman Diane Watson (D-CA) and Senator Sam Brownback (R-KS). The legislation would allow terminally ill patients to have access to new treatments as early as the completion of phase 1 trials. It also would expand the existing accelerated approval process for promising new treatments by allowing compassion use exemptions for seriously ill patients for drugs that have demonstrated clinical benefits in phase 2 trials.

©2008 American Academy of Neurology