May 24, 2022. We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.
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.
STAT Report : The need for speed and safety: A primer on the FDA’s drug approval pathways
This STAT report provides an excellent primer on FDA’s drug approval pathways, and the controversies about whether patients can be harmed when FDA standards get too lose. Dr. Diana Zuckerman describes the need for the FDA Commissioner to restore the public’s trust.
Read More »Patient, Consumer, and Public Health Coalition Letter on FDA Amendments Act H.R. 7667
May 17, 2022: We are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. There are numerous important provisions in the FDA Act, but in this letter we will focus on two major issues: accelerated approval and contrast imaging agents.
Read More »NCHR Comments on Hormone Therapy in Postmenopausal Women for the Primary Prevention of Chronic Conditions
May 16, 2022. The currently available evidence on hormone therapy is very clear: Whether combination therapies of estrogen and progestin or treatments with estrogen alone, the risks by far outweigh the limited benefits for postmenopausal women. We thus strongly support USPSTF’s “D” grade recommendation against the use of combined estrogen and progestin for the primary prevention of chronic conditions such as cardiovascular disease, types of cancer, and osteoporotic fractures in postmenopausal persons, as well as the “D” grade recommendation against the use of estrogen alone in postmenopausal persons who have had a hysterectomy.
Read More »NCHR Comments on EPA truck pollution standards
May 16, 2022. NCHR agrees with the Environmental Protection Agency (EPA) that the proposed truck pollution standards, which would reduce emissions of smog- and soot-forming nitrogen oxides, are a crucial step towards EPA’s commitment to climate, clean air and environmental justice. However, in light of the ongoing health and climate crisis, the proposed standards fall short of a zero-emission transportation future, and we urge EPA to further strengthen the proposed standards. This has also long been requested by environmental justice communities across the country, because while truck pollution has been devastating the health of communities across the country, it has a disproportionate impact on communities of color.
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