November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.
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.
Testimony of Patient, Consumer, and Public Health Coalition at Patient Engagement Device Advisory Committee Meeting
October 30, 2024: Tess Robertson Neel testified at the FDA Patient Engagement Device Advisory Panel on behalf of the Patient, Consumer, and Public Health Coalition regarding informed consent. We support the FDA’s proposed improvements, suggests a short, easy to read checklist format to improve fully informed consent, and highlights the need to enforce FDA recommendations or improve incentives for compliance.
Read More »Testimony of Laura Lytle at the FDA Patient Engagement Device Advisory Committee Meeting
October 30, 2024: NCHR’s Laura Lytle testified at the FDA Patient Engagement Device Advisory Panel meeting in support of the FDA’s proposed guidance for informed consent, but suggested 4 key areas for improvement: using a short, simple checklist to ensure that patients understand the risks; focusing on informed consent as a process not a document; simple summaries of key information; and ensuring patient privacy.
Read More »NCHR Public Comment to CDC Safety Office on COVID Vaccine Research and Communications
October 11, 2024: We presented our public comment at the NASEM Review of CDC COVID-19 Vaccine Safety Research and Communications Meeting 3 on how CDC could improve research and communications regarding COVID-19 vaccines. We said CDC needs to be clear on what is known and not known and needs to quantify what is known about adverse events and complications from vaccines.
Read More »NCHR Public Comment on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
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