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.

Invited Panel Presentation of Dr. Diana Zuckerman at FDA OMUFA Meeting

November 20, 2024: We were invited to present at the FDA OMUFA November 2024 meeting on the OTC user fee program commitment letter. We appreciate the priority given to safety OMORs (Monograph revisions) but are concerned that the funding is focused on speed of reviews and industry access to FDA staff, not to pay for staff to conduct FDA safety reviews of OTC medications being sold for years without evidence of safety and effectiveness. OTC products will be safer if consumers and public health experts are present when negotiations take place.

Testimony of Dr. Zuckerman at FDA Joint Advisory Committees Meeting on Clozapine REMS for Neutropenia

November 19, 2024: We testified at the FDA Advisory Committees joint meeting that the REMS to prevent neutropenia in Clozapine patients is essential to save lives, but that some barriers to patient access should be reduced. Clozapine can cause a dangerous reduction in an important type of white blood cells, making patients vulnerable to infections that require hospitalization and can be fatal.

Statement of Dr. Diana Zuckerman At the FDA General and Plastic Surgery Devices Advisory Panel on ProSense Cryoablation System

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.

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.

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.