Recent Meeting with Health Canada Regarding Generic Concerta

CADDAC National Director

On October the 31st CADDAC and CADDRA, as well as other stake holders, met with Health Canada to present our activities over the past six years and express our continued concerns in regards to the bioequivalency, or more accurately the lack of therapeutic equivalence, of the generic forms of the brand name ADHD medication Concerta.  Heidi Bernhardt President and Executive Director of CADDAC presented information on past advocacy efforts, patient feedback and patient surveys carried out to obtain patient feedback on this issue. In addition she addressed the continued challenges CADDAC is experiencing in having patients and caregivers report on adverse events such as the decrease in symptom control and increase in side effects of these medications. Dr. Doron Almagor, President of CADDRA, reviewed the individual and societal impact of ADHD and summarized Canadian and US adverse events and lack of efficacy reporting on these generic medications. Dr. Murray Ducharme covered the different processes and timing of absorption, peaking and elimination of the brand versus generic medications and why they are not therapeutically equivalent or bioequivalent. Dr. Judy van Stralen presented on three studies which demonstrated the difference between Concerta and the TEVA generic product. In addition she spoke about the additional wait times this issue has added to her clinic. Several of the presenters also shared specific troubling patient cases with bad outcomes due to substitution by the generic medication.

At the close of the meeting all were informed that we would receive a decision within the next month on what the Health Canada’s next steps might be.

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