Abigail Alliance v. von Eschenbach
Encyclopedia
Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach was resolved in early 2008 when the Supreme Court of the United States
declined to hear the appeal. Their refusal left standing the appellate court decision, which said that patients have no right to "a potentially toxic drug with no proven therapeutic benefit."
and sued the FDA for access to Erbitux. At that time, Erbitux was available experimentally only for patients participating in colon cancer clinical trial
s. The argument made by the Abigail Alliance in court was that terminal cancer patients have a constitutionally protected right to access to experimental medications
before the FDA approves them. Specifically, the Abigail Alliance argued that the FDA should license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. If successful, the suit would have eliminated FDA prohibitions on selling unapproved drugs, and left the decision entirely in the hands of drug manufacturers.
From its inception, the US Government has charged the FDA with a mission of overseeing testing of new drugs. Challenges to this core definition, as in the Abigail Alliance court case, would likely require broad changes to the FDA's operating mandate.
Implementing the changes proposed by the Abigail Alliance would have exposed some terminally ill patients to treatments which would ultimately not be approved because of inefficacy and toxicity. The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients The expected success rate of cancer drugs at the Phase I stage of clinical testing is 6%.
If the Abigail Alliance had been successful in court, the suit would have radically altered the conduct of clinical cancer research, by providing almost unfettered legal access to experimental drugs by terminally ill patients, who would then have little incentive to enter Phase II and Phase III clinical trials, which are used to determine side effects and efficacy of new drugs. While eligibility factors and geography may limit the ability of some terminally ill patients to access new drugs through clinical trials, those trials also protect patients by collecting safety and efficacy data on new drugs under controlled circumstances.
.
The FDA requested that the Court of Appeals rehear the case. The American Society of Clinical Oncology (ASCO
) filed an amicus brief to the U.S. Court of Appeals in advance of the March 1 hearing, supporting the FDA's position. ASCO
proposed that the Constitution does not guarantee the right to access unapproved medications, and that the court case threatens the cancer clinical trial enterprise.
On March 1, 2007, the U.S. Court of Appeals for the District of Columbia reheard the case en banc
. On August 7, 2007 the Court issued an 8-2 decision against the Abigail Alliance, reversing the previous panel decision, thereby upholding the previous court decision that found no constitutional right to unapproved drugs by terminally ill patients. Judge Judith Rogers and Chief judge Douglas Ginsburg dissented.
Frank Burroughs, Abigail's father, vowed to pursue an appeal to the Supreme Court,
but the Supreme Court declined to accept the case, which effectively ended the case with the existing FDA regulations intact.
Supreme Court of the United States
The Supreme Court of the United States is the highest court in the United States. It has ultimate appellate jurisdiction over all state and federal courts, and original jurisdiction over a small range of cases...
declined to hear the appeal. Their refusal left standing the appellate court decision, which said that patients have no right to "a potentially toxic drug with no proven therapeutic benefit."
Background
Abigail Burroughs was a college student diagnosed with head and neck cancer. During the later phases of her treatment, Abigail's father, Frank Burroughs, formed an organization, the Abigail Alliance for Better Access to Developmental DrugsAbigail Alliance for Better Access to Developmental Drugs
The Abigail Alliance for Better Access to Developmental Drugs is a 501 non-profit organization, incorporated in Virginia in 2001. According to its website, its main mission is "to help cancer patients and others with life threatening illnesses."...
and sued the FDA for access to Erbitux. At that time, Erbitux was available experimentally only for patients participating in colon cancer clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s. The argument made by the Abigail Alliance in court was that terminal cancer patients have a constitutionally protected right to access to experimental medications
Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines before a marketing application for the drug has been approved...
before the FDA approves them. Specifically, the Abigail Alliance argued that the FDA should license drugs for use by terminally ill patients with "desperate diagnoses," after they have completed Phase I testing. If successful, the suit would have eliminated FDA prohibitions on selling unapproved drugs, and left the decision entirely in the hands of drug manufacturers.
From its inception, the US Government has charged the FDA with a mission of overseeing testing of new drugs. Challenges to this core definition, as in the Abigail Alliance court case, would likely require broad changes to the FDA's operating mandate.
Implementing the changes proposed by the Abigail Alliance would have exposed some terminally ill patients to treatments which would ultimately not be approved because of inefficacy and toxicity. The Society for Clinical Trials opposes US legislation to permit marketing of unproven medical therapies for seriously ill patients The expected success rate of cancer drugs at the Phase I stage of clinical testing is 6%.
If the Abigail Alliance had been successful in court, the suit would have radically altered the conduct of clinical cancer research, by providing almost unfettered legal access to experimental drugs by terminally ill patients, who would then have little incentive to enter Phase II and Phase III clinical trials, which are used to determine side effects and efficacy of new drugs. While eligibility factors and geography may limit the ability of some terminally ill patients to access new drugs through clinical trials, those trials also protect patients by collecting safety and efficacy data on new drugs under controlled circumstances.
Progression of the case
In May, 2006, the U.S. Court of Appeals for the District of Columbia ruled in favor of the Abigail Alliance, and found that the US Constitution protects the right of terminally ill patients to access treatments that are not approved by the Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
.
The FDA requested that the Court of Appeals rehear the case. The American Society of Clinical Oncology (ASCO
Ascó
Ascó is a large village in the comarca of Ribera d'Ebre, Catalonia, Spain, on the right bank of the Ebre river. The village of Ascó is known for its nuclear power station, and for excellent fishing in the river....
) filed an amicus brief to the U.S. Court of Appeals in advance of the March 1 hearing, supporting the FDA's position. ASCO
Ascó
Ascó is a large village in the comarca of Ribera d'Ebre, Catalonia, Spain, on the right bank of the Ebre river. The village of Ascó is known for its nuclear power station, and for excellent fishing in the river....
proposed that the Constitution does not guarantee the right to access unapproved medications, and that the court case threatens the cancer clinical trial enterprise.
On March 1, 2007, the U.S. Court of Appeals for the District of Columbia reheard the case en banc
En banc
En banc, in banc, in banco or in bank is a French term used to refer to the hearing of a legal case where all judges of a court will hear the case , rather than a panel of them. It is often used for unusually complex cases or cases considered to be of greater importance...
. On August 7, 2007 the Court issued an 8-2 decision against the Abigail Alliance, reversing the previous panel decision, thereby upholding the previous court decision that found no constitutional right to unapproved drugs by terminally ill patients. Judge Judith Rogers and Chief judge Douglas Ginsburg dissented.
Frank Burroughs, Abigail's father, vowed to pursue an appeal to the Supreme Court,
but the Supreme Court declined to accept the case, which effectively ended the case with the existing FDA regulations intact.
See also
- Expanded accessExpanded accessExpanded access refers to the use of an investigational drug outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress...
, a long-standing FDA program for providing experimental drugs to patients - Cases and Materials on Torts, 9th ed. (2008) Richard A. Epstein. (pp. 42)