November 5, 2016. While quinolones can be life-saving drugs for certain types of infections, we must re-examine their safety and efficacy in light of new information to ensure the benefits outweigh the harms.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
Here are our Statements and Positions on issues that affect you.
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’s Comment on USPSTF’s Draft Recommendation Statement for Child Maltreatment: Primary Care Interventions
Given the burden of child maltreatment on our society’s children, it is critical to continuously evaluate any new evidence to find effective interventions that can prevent child maltreatment.
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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