August 3, 2018. TIRFs provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks. These REMS are not working as well as the should to protect patients and need to be approved.
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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.
Read More »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.
Read More »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.
Read More »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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