NCHR Testifies Against New Testosterone Pill

January 9, 2018. Testosterone replacement can help patients with hypogonadism live a normal life. A new oral drug might be beneficial, but this drug raises concern of potential harms. On a chemical level, the drug works, but we don’t know whether it meaningfully helps patients in the long run. Long term studies with patient-centered outcomes may provide more certainty. In addition, the data do not provide reasonable assurance that this drug is safe. We need additional safety data and drug interaction data before this drug is approved. Furthermore, if we consider potential misuse as part of the risk/benefit evaluation, then the potential for harm surely exceeds the drug’s benefits. Therefore we cannot recommend approval at this time.

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NCHR Comments on the FDA’s Opioid Public Steering Committee (OPSC)

December 21, 2017. We applaud the FDA for addressing their role in developing strategies to “confront” the opioid crisis. We agree that the magnitude and scope of this crisis requires urgent action and agree that the FDA should consider patients’ and other relevant groups’ interests in developing effective approaches to reduce further harm from opioids.

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