Matt Collins
08-09-2007, 12:13 PM
Dying Patients Can't Take Unapproved Medicine
Do mentally sound, terminally ill patients have a constitutional right to choose to take promising experimental drugs not yet approved by the FDA?
No. Not even if it would save their lives, declared the U.S. Court of Appeals for the District of Columbia, in an 8-2 ruling Tuesday, August 07:
"This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective. . . . we conclude that there is no fundamental right 'deeply rooted in this Nation's history and tradition' of access to experimental drugs for the terminally ill . . ."
Full FDA testing and approval for a new drug can take up to 10 years -- a long time to wait, if you're terminally ill.
The Abigail Alliance for Better Access to Developmental Drugs had argued that dying patients should have access to unapproved medicines that have cleared early safety tests.
Ironically, every drug the Abigail Alliance has sought access to over the past six years eventually was approved by the FDA... but too late for many patients.
The ruling is bad news for dying patients who might benefit from promising new drugs. However, perhaps they will take some comfort, as they suffer and die, in knowing that the FDA protected them from possible side-effects of drugs that might have saved their lives.
The Abigail Alliance plans to appeal to the Supreme Court.
(Sources: http://www.reuters.com/article/domesticNews/idUSN0723277720070807
http://volokh.com/posts/1186495767.shtml )
Do mentally sound, terminally ill patients have a constitutional right to choose to take promising experimental drugs not yet approved by the FDA?
No. Not even if it would save their lives, declared the U.S. Court of Appeals for the District of Columbia, in an 8-2 ruling Tuesday, August 07:
"This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed limited safety trials but have not been proven safe and effective. . . . we conclude that there is no fundamental right 'deeply rooted in this Nation's history and tradition' of access to experimental drugs for the terminally ill . . ."
Full FDA testing and approval for a new drug can take up to 10 years -- a long time to wait, if you're terminally ill.
The Abigail Alliance for Better Access to Developmental Drugs had argued that dying patients should have access to unapproved medicines that have cleared early safety tests.
Ironically, every drug the Abigail Alliance has sought access to over the past six years eventually was approved by the FDA... but too late for many patients.
The ruling is bad news for dying patients who might benefit from promising new drugs. However, perhaps they will take some comfort, as they suffer and die, in knowing that the FDA protected them from possible side-effects of drugs that might have saved their lives.
The Abigail Alliance plans to appeal to the Supreme Court.
(Sources: http://www.reuters.com/article/domesticNews/idUSN0723277720070807
http://volokh.com/posts/1186495767.shtml )