May 17. 2021. We enthusiastically support the proposal to withdraw the January exemption for the Class 1 gloves noted above, returning the requirement for a report under section 510(k) of the FD&C Act.
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’s Testimony to FDA on the TriGUARD 3 Device
NCHR’s Dr. Meg Seymour testified at an FDA Advisory Committee about why the TriGUARD 3 device is not substantially equivalent to its predicate device, Sentinel. She explained that TriGUARD 3 failed to meet its primary effectiveness endpoint, with patients twice as likely to have a stroke compared to the control group.
Read More »NCHR’s Testimony to FDA on the TransMedics® Organ Care System™ (OCS) Liver System
NCHR Fellow Dr. Meg Seymour testified at an FDA Advisory Committee regarding concerns about the TransMedics Organ Care System (OCS) Liver System. While the device showed superiority on a surrogate endpoint, it did not improve survival compared to traditional cold storage and introduced additional risks caused by device malfunction and organ damage.
Read More »Scientific Coalition Letter on Aduhelm to HHS Inspector General, CMS, and Congress
July 7, 2021. As organizations working to promote and protect science for the public good, we are writing to express our concern about the lack of scientific evidence to support the FDA’s recent accelerated approval of Biogen’s Aduhelm (aducanumab) as a drug intended to slow cognitive damage caused by Alzheimer’s disease.
Read More »NCHR’s Comments on AHRQ’s Draft Report on Integrated Pain Management Programs
June 21, 2021. While we agree with the stated objective of a report evaluating the effectiveness and harms of pain management programs in the Medicare population, this report has several serious limitations.
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