(Download) "Bound Guidance: FDA Rulemaking for Off-Label Pharmaceutical Drug Marketing." by Case Western Reserve Law Review * eBook PDF Kindle ePub Free

eBook details

Title: Bound Guidance: FDA Rulemaking for Off-Label Pharmaceutical Drug Marketing.
Author : Case Western Reserve Law Review
Release Date : January 01, 2010
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 318 KB

Description

INTRODUCTION On December 30, 1993, the United States Food and Drug Administration ("FDA") approved gabapentin, a drug marketed and distributed by Parke-Davis Pharmaceuticals Company, for "adjunctive therapy in the treatment of partial seizures ... in patients above the age of 12 years." (1) The drug was hailed as a welcome advance in the study of epilepsy, a field that scientists are only beginning to understand. (2) In clinical trials, gabapentin's results were impressive. In one study, gabapentin corresponded with a fifty percent reduction in seizures for twenty-three percent of epileptic patients, in comparison to a nine percent reduction in the placebo group. (3) Gabapentin's potential use, however, may well extend beyond treatment of seizures. Although it will not be a 'miracle solution' to all ailments involving neuropathic pain, (4) numerous studies suggest that gabapentin may have uses far beyond the scope of its FDA approval. (5)