February 15, 2018. It remains unclear whether individual achievement of abstinence is sustainable over time and whether long-term NRT use is more or less beneficial on an individual or population health level. We commend the FDA for addressing their role in developing strategies to evaluate NRT products and labeling. We agree that urgent action is necessary and the FDA should consider science-based approaches to reduce further harm from combustible tobacco products.
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NCHR Testimony On Long Acting Nerve Blocking Agent, Exparel
FDA, February 15, 2018. We need post-surgical pain treatments that spare patients from opioid use. However, at this time, the data are insufficient to recommend supplemental approval of Exparel.
Read More »NCHR Testimony at FDA About New Opioid Combination, Hydexor
February 14, 2018. Consider how this drug fits into the context of the drug market and how it is likely to be used or misused. Do the benefits outweigh the risks of putting another conventional opioid on the market, one that is designed to treat its own side effects, and are the attempts to reduce excess pills sufficient? Opioids provide both a benefit and a harm in our society. As Advisory Board members, please advise the FDA to carefully and cautiously consider the potential for abuse of this opioid.
Read More »NCHR Testifies Against Oral Testosterone Drug
January 10, 2018. Testosterone replacement therapy can substantially benefit patients with hypogonadism. While we recognize that oral administration is preferable to more inconvenient routes of administration, we cannot disregard concerns about this drug’s potential harms. This drug was not studied for a long enough time to know if the benefits outweigh the risks, and off-label use makes it even more likely that the risks will often outweigh the benefits.
Read More »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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