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- Title
A New Era of Unapproved Drugs.
- Authors
Jacobson, Peter D.; Parmet, Wendy E.
- Abstract
The article presents an editorial that discusses the court case of Abigail Alliance for Better Access to Developmental Drugs v Von Eschenbach and its implications on the access to drugs unapproved by the U.S. Food and Drug Administration (FDA). In the case, a 3 judge panel on the U.S. Court of Appeals ruled that terminally ill patients have a constitutional right to buy unapproved drugs that have gone through phase I drug testing. Frank Burroughs started the Abigail Alliance after his daughter, Abigail Burroughs, died from squamous cell carcinoma of the head and neck. He worked to allow for greater patient access to drugs in the early stages of development and testing. The author discusses implications of removing FDA regulatory power over drug safety and effectiveness.
- Subjects
UNITED States; DRUG development; CLINICAL drug trials -- Law &; legislation; CLINICAL pharmacology; DRUG monitoring; BURROUGHS, Frank; BURROUGHS, Alice; UNITED States. Food &; Drug Administration
- Publication
JAMA: Journal of the American Medical Association, 2007, Vol 297, Issue 2, p205
- ISSN
0098-7484
- Publication type
Editorial
- DOI
10.1001/jama.297.2.205