AUTHOR RESPONDS: Generic substitution of antiepileptic drugs: What's a clinician to do?
MichaelPrivitera, University of Cincinnati Neuroscience Institute, CincinnatiPrivitmd@ucmail.uc.edu
Submitted June 21, 2014
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.
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.