AUTHOR RESPONDS: Generic substitution of antiepileptic drugs: What's a clinician to do?

I thank Drs. Shubhakaran and Khichar for their thoughtful comments on our article.¹ In the United States, we often forget how our regulatory decisions may have far-reaching impact on health policy elsewhere in the world. Our studies are designed to determine whether doing generic equivalence testing using subjects with epilepsy and combining single and chronic dose studies will improve generic quality. Widespread generic substitution will markedly reduce health care costs worldwide, but our patients with epilepsy need to be assured that generic substitution and generic product switches will not adversely affect seizure control or side effects.

Disclosures: M. Privitera serves on a DSMB for Upsher Smith and as a consultant for Eli Lilly, serves on the editorial board for Annals of Pharmacotherapy, has served on the Speakers' Bureau for UCB and Pfizer, and receives research support from UCB, Eisai, Neuren Pharmaceuticals, the NIH, and the FDA.

Reference

1. Privitera M. Generic substitution of antiepileptic drugs: what's a clinician to do? Neurol Clin Pract 2013;3:161-164.