December 2, 2022: NCHR testified at an FDA meeting that there is strong evidence that commonly-used pulse oximeters are less reliable for patients with pigmented skin. The FDA’s current guidelines do not require product labeling to address the impact of skin pigmentation on pulse oximetry. While labeling is important to alert users to possible inaccuracies, it does not diminish the importance of developing devices that are effective for everyone.
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.
National Center for Health Research (NCHR) Comment on FDA proposed ruling for ACNU Nonprescription Drug Products
November 25, 2022: We appreciate the FDA’s interest in establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). However, the FDA has not identified a mechanism to ensure appropriate use. Based on our experience with patients across the country, we believe it would be impossible to do so. For that reason, we do not support the proposed ruling.
Read More »National Center for Health Research Comment on Proposed Labeling Recommendations for Patients Considering LASIK
November 25, 2022: NCHR does not support nonbinding FDA LASIK guidance saying it is not enforceable and does not protect patients. We strongly urge the FDA to require patients to be provided with short, easy-to-understand labeling prior to scheduling surgery, and that the FDA improve their example of a LASIK Patient Checklist to provide more balanced information about risks.
Read More »National Center for Health Research National Long COVID Conference on October 3, 2022
October 3, 2022: NCHR’s National Long COVID conference was held in Washington, DC. Topics included autoimmunity, ME/CFS, Caregiving, Children and Teens, Dept of Veterans Affairs, and Research.
Read More »NCHR criticism of drug for chronic kidney disease at FDA Advisory Committee Meeting
November 16, 2022: Elevated phosphorus is a serious complication encountered by the majority of patients with chronic kidney disease on dialysis. Tenapanor represents a novel approach to this major problem. Still, we are concerned about this product because the data do not show it to be more effective than current options, and the significant side effects may lead to poor patient compliance.
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