February 18, 2016. Leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology.
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NCHR Testimony at FDA on Vortioxetine Treatment of Cognitive Dysfunction in Major Depressive Disorder
February 3, 2016. NCHR urges FDA to conclude that there is insufficient data to claim that vortioxetine is effective in providing a meaningful improvement in cognitive dysfunction associated with MDD.
Read More »NCHR Testimony on Probuphine at FDA Advisory Committee Meeting
January 12, 2016. We need safe and effective treatment options for opioid addiction. Unfortunately, the risk-benefit profile of probuphine does not support its approval for the population studied.
Read More »NCHR Testimony at FDA on IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT)
December 14, 2015. The very small chance of any potential benefit and the high cost of preventing one cardiovascular event lead us to conclude that ezetimibe is not the cure most patients desire.
Read More »NCHR Testimony at FDA on Drisapersen for Duchenne Muscular Dystrophy
November 24, 2015. Drisapersen is a drug being studied for Duchenne muscular dystrophy. However, a recent large, phase 3 clinical trial did not find that it was effective at helping patients walk further.
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