Questioning the Bioequivalence Standards for Antiepileptic Drugs
Monday, May 12, 2014
9:00 a.m.-4:00 p.m.
Building 31 Great Room, Section A, FDA WO Campus
Questioning the Bioequivalence Standards for Antiepileptic Drugs: Implications for Regulation of Narrow Therapeutic Index Drugs
The FDA's approach for determining the bioequivalence between generic and brand products has met with controversy since the establishment of the Abbreviated New Drug Application (ANDA) process by the Hatch-Waxman Amendments.
1). It has been argued that current bioequivalence standards may not be sufficient in special patient populations (e.g. generic brittle epilepsy patients) using AEDs where small differences in dose may lead to clinically significant blood concentration-dependent adverse effects. The concern over the safety and efficacy of generic antiepileptic drugs (AED) approved under the current ANDA process has impacted physician prescription practices and, moreover, led to consensus statements from professional societies and patient-advocate groups opposing the generic substitution of AEDs without physician approval
2). The conference is intended to foster productive interdisciplinary discussion, among healthcare professionals, scientists, consumers, members of industry and government officials, on the effectiveness of current regulatory standards governing generic drug approval. This conference will be a forum to establish the most appropriate and acceptable approach for assessing generic bioequivalence to ensure therapeutic equivalence. The focus will be AED bioequivalence in epilepsy patients; however, conclusions drawn from this conference may be relevant for the regulatory oversight of other drugs as well, such as immunosuppressant drugs.