March 1, 2016. Opioid abuse is a crisis in the US. We urge the FDA to perform its own independent assessment of the effectiveness of REMS and make this data publicly available. More transparency is needed to enable us all to work together to find more effective solutions to the challenge of opioid abuse.
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.
NCHR Testimony at 2016 FDA Public Meeting on Demographic Subgroup Data
February 29, 2016. The FDA should make it clear that the agency will not approve medical products for all populations if the sponsor has not tested the product for safety and effectiveness on all major demographic subgroups and provided meaningful subgroup analyses.
Read More »Patient, Consumer, and Public Health Coalition Testimony at 2016 FDA Public Meeting on Demographic Subgroup Data
February 29, 2016. The FDA should make it clear that the agency will not approve medical products for all populations if meaningful subgroup analysis for safety and effectiveness were not conducted for major demographic groups.
Read More »NCHR Testimony at 2016 FDA Meeting on the Classification of Urogynecologic Surgical Mesh Instrumentation and Automated, Blood Cell and Plasma Separators
February 26, 2016. There are a number of devices currently on the market that pose safety risks to the public because they were inappropriately designated Class I. The upclassification of the surgical mesh instrumentation from class I to class II as well as the new classification of centrifuge apheresis devices as class II are both moves towards increasing patient safety. The special controls suggested by the FDA should be carefully evaluated to determine if they are adequate to protect patients from undue harm.
Read More »NCHR Testimony at FDA on TOPAS Treatment for Fecal Incontinence
February 25, 2016. The lack of a comparison group or data for substantial groups of women most likely to suffer from fecal incontinence makes it impossible to determine if this device would benefit them. A control group is needed to determine if the device is effective for anyone, and if it is, it should be approved only for the types of women studied, not for the types of women who were intentionally excluded.
We encourage you to recommend that these studies be conducted before a decision is made about whether or not to approve this device.