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- Title
Giving the Terminally Ill Their Due (Process): A Case for Expanded Access to Experimental Drugs through the Political Process.
- Authors
Leibfarth, Linda Katherine
- Abstract
The article offers information on the Access, Compassion, Care and Ethics for Seriously Ill Patients Act (ACCESS Act) in the U.S. in 2008. The Act contains many aspects of contractarian model within the existing regulatory framework of the Food and Drug Administration (FDA). Moreover, the bill affirms that seriously ill patients have the right to access experimental drugs and that FDA's case-by-case Compassionate Use exemption must be covered to all seriously ill patients. The legislation envisions a three-tiered system in regulating new drugs.
- Subjects
UNITED States; UNITED States. Food &; Drug Administration; TERMINALLY ill; LEGISLATION; PATIENTS; PUBLIC health laws; DRUG laws; CLINICAL trials; SCIENTIFIC community
- Publication
Vanderbilt Law Review, 2008, Vol 61, Issue 4, p1281
- ISSN
0042-2533
- Publication type
Article