NCHR Testimony on Nucala for Eosinophilic COPD

July 26, 2018. New products must provide a real and clinically meaningful benefit, not just a hope that the treatment works. Unfortunately, the clinical trial data presented today do not provide substantial evidence that mepolizumab [Nucala] provides this benefit for patients with COPD and high eosinophil counts.

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NCHR Testimony at FDA on Approval of Abuse-Deterrent Opioid, Remoxy

June 26, 2018: To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high and truthful standard. Remoxy did not meet the FDA’s standards for oral abuse, and it remains unclear whether it can be abused intravenously. The safety of the excipient is also in question. Please carefully consider the risks of putting another drug with abuse-deterrent labeling on the market that could result in misuse and abuse in the real world. We urge this Advisory Committee to vote that the benefits of this drug do not outweigh its risks.

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NCHR Testimony at FDA on ELEVAIR Endobronchial Coil System

June 14, 2018. The pivotal trial does not provide sufficient evidence for effectiveness or safety. Questions about whether the device is effective are exacerbated by the lack of consistency with the crossover data, the differences between US patients and those outside the US, and the lack of blinding. The long-term follow up data are difficult to interpret without controls.

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NCHR Testimony at the FDA about a Circulatory System Device

June 12, 2018. Since it is a high-risk device, the INCRAFT AAA Stent Graft System should be held to a high standard for approval. As you determine whether you have reasonable assurance of this device’s safety and effectiveness, we urge you to consider the benefits and risks for patients.

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NCHR Testimony at FDA about Buprenorphine Sublingual Spray, Buvaya

May 22, 2018: Opioids can be greatly beneficial and, as we all know too well, can also produce tremendous harms for patients suffering from pain. Buvaya presents concerning safety issues, its benefits seem minimal, and the delayed benefit for patients may result in overuse or misuse in the real world. Please carefully consider the risks of putting another non-abuse-deterrent opioid on the market and whether the sponsor’s attempts to reduce misuse and abuse are sufficient. We do not think so and more important, there is no evidence demonstrating that this product will be misused less often than other opioids. We therefore urge you to vote that the benefits of Buvaya do not outweigh its risks.

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