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Giving The Terminally Ill Their Due (Process): A Case For Expanded Access To Experimental Drugs Through The Political Process, Linda K. Leibfarth

Vanderbilt Law Review

The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health." In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective. However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal. At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment. Advocates for these patients …