December 10, 2021. We agree with the FDA reviewers that the data presented today do not support the claim that the specific device that the company plans to market is either reasonably safe or reasonably effective.
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 Bardoxolone for Kidney Failure from Alport Syndrome
December 8, 2021: We agree with FDA scientists that bardoxolone does not demonstrate effectiveness at slowing the loss of kidney function and reducing the risk of progression to kidney failure, which are the outcomes that matter most to patients.
Read More »NCHR Comments on USPSTF’s Draft Recommendation on Screening for Chronic Obstructive Pulmonary Disease
December 6, 2021. We strongly support the “D” grade reaffirmation of the 2016 recommendation against screening for COPD in asymptomatic adults. There is simply not sufficient evidence that screening for COPD in asymptomatic adults (or treatments for asymptomatic adults) reduce morbidity or mortality or improve health-related quality of life.
Read More »NCHR’s Testimony to FDA About Molnupiravir for COVID-19
November 30, 2021: For molnupiravir, the balance of benefits and risks may differ between different types of patients, and not all types of patients were studied.
Read More »GDUFA III Statement of Dr. Diana Zuckerman, President of the National Center for Health Research
November 16, 2021: There are issues of safety and effectiveness in the GDUFA III Commitment letter.
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