July 26, 2011 -The Epilepsy Foundation joined the American Epilepsy Society, American Academy of Neurology, International League Against Epilepsy, and the National Association of Epilepsy Centers in a comment letter to the FDA Advisory Committee for Pharmaceutical Science & Clinical Pharmacology. In addition, Epilepsy Foundation President & CEO Rich Denness presented public remarks to the committee at the FDA today.
This is the same committee that made recommendations on the narrow therapeutic index and bioequivalence issues in April 2010. According to FDA, “a generic drug is approved based on its pharmaceutical equivalence and bioequivalence, and therefore therapeutic equivalence to the reference listed drug” [approved brand name medication]. The Epilepsy Foundation is interested in today’s discussion of the appropriate bioequivalence and quality standards because this issue relates to antiepileptic drugs (AEDs) and medication switching.
From the patient and consumer perspective, FDA bioequivalence standards are used by pharmacies and insurers to authorize automatic substitution among drug products. Many patients and physicians report problems when switching between different manufacturers’ versions of the same AED. The Epilepsy Foundation, along with the American Epilepsy Society and the American Academy of Neurology, recommends that consent must be obtained from the individual with epilepsy and their physician before any such substitutions are made to avoid potentially life-threatening seizures.
The Epilepsy Foundation believes it is critically important to the health and safety of patients that the FDA ensure the scientific validity of all bioequivalence standards. We value the cost-savings that generic medications present to all consumers; however, there has been longstanding concern for the Epilepsy Foundation, our patient community, and physicians about medication switching. FDA bioequivalence studies include healthy volunteers, and do not include testing on individuals with epilepsy; the results do not necessarily reflect the safety, potential for breakthrough seizures, or side effects that are relevant for people with epilepsy. In addition, bioequivalence standards do not incorporate comparisons between generic products – one of the main areas of concern among epilepsy experts for patients who switch between different versions of the same AED.
As the FDA committee addresses this topic, the Foundation recommends that:
· The FDA and the Committee incorporates a definition of narrow therapeutic index (NTI) or critical dose drugs that includes AEDs;
· This committee put forward the questions addressed today for public comment and input;
· The FDA consider making the issue of AED bioequivalence a special topic for an advisory committee meeting;
· The FDA continue to expand its scientific research investment on AED bioequivalence and involve the epilepsy patient and physician community in the research design; and
· As research outcomes are known and published, we hope the FDA will work with the Foundation and epilepsy community to communicate and translate that research for patients and providers.
> Epilepsy Foundation public comments are available by clicking here
> Click here to view epilepsy community joint comment letter
For more information on medication switching, visit the Foundation resources at:
For more information the FDA Advisory Committee for Pharmaceutical Science & Clinical Pharmacology: