June 23, 2014. As members of the Patient, Consumer, and Public Health Coalition, many of whom have worked with your staff for years, we are writing to express our concerns that you have not worked with us in your role as a leader in the 21st Century Cures project.
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.
Lawmakers Respond to Advocates’ Concerns About Innovation Initiative
FDA Week, July 17, 2014. Lawmakers appeared to respond to concerns that the House Energy & Commerce Committee is receiving a one-sided, industry-backed patient perspective as part of its 21st Century Cures Initiative by soliciting comments July 11 from other groups and calling for a balance between the push for more expedited approvals and public health safeguards.
Read More »NCHR Testimony to the Obstetrics and Gynecology Devices Panel Morcellation Devices for Uterine Fibroid Removal
July 11, 2014. We need higher standards to ensure that morcellation devices are safe and effective, and that require clinical trials with sufficient numbers of patients to determine the risks of rare but fatal outcomes.
Read More »NCHR Testimony at the Advisory Committee on Minority Health, Department of Health and Human Services
July 8, 2014. Racial and ethnic minorities are rarely included in sufficient numbers in clinical trials used as the basis of FDA approval of drugs and medical devices. And yet, these are the medical products that all patients — including millions of people of color — rely on.
Read More »Patient, Consumer, and Public Health Coalition Concerned that Proposed Regulatory Framework for Health Information Technology Will Undermine FDA’s Mission
July 7, 2014. Health care providers and patients rely on the FDA to establish that a device is reasonably safe and effective. If FDA does not carefully scrutinize health IT products to evaluate evidence that those that are devices have benefits that outweigh the risks, patients may be seriously harmed.
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