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 Comments On FDA’s Requirements for Tobacco Product Manufacturing Practices

October 6, 2023, in response to FDA’s draft guidance on tobacco manufacturing practices, NCHR recommends that the FDA requires manufacturers to accurately reflect the nicotine concentration of their products using clear labeling, restrict flavor additives, and impose maximum nicotine levels. We also urge FDA to exercise its full authority for manufacturer violations to improve incentive for compliance.

NCHR Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling

September 25, 2023: NCHR supported the use of Dietary Guidance Statements to reduce nutrition-related chronic diseases and advance health equity. We made recommendations regarding dietary statements for products that exceed recommended amounts, or contain fruit juice, whole grains, and alcohol.

Dr. Diana Zuckerman’s Testimony at the FDA Advisory Committee on NurOwn for ALS Treatment

September 27, 2023: NCHR’s Diana Zuckerman’s testified at FDA’s Advisory Committee meeting on September 27, 2023 about tripling of deaths and no benefits of NurOwn treatment for ALS. Improvements were identical for placebo compared to NurOwn treatment, and patients should not have to pay for unproven treatment. Experimental treatment should be free through clinical trials or expanded access.

NCHR Comments on the Proposed Framework from Ranking Member Cassidy to Regulate Artificial Intelligence (AI) in Healthcare

September 22, 2023: NCHR urged the need to reform the 510k clearance pathway for AI/machine learning (ML) devices, promote diversity in the data used for AI, and the need to routinely test effectiveness of updated systems, including post market surveillance.

NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

September 12, 2023: Noncompliance with required post-market studies (PMRs) is a serious problem that undermines FDA’s authority and the public trust in FDA decision-making.NCHR supports the process described in the guidance for applicants to correct circumstances that led to non-compliance with the agreed upon PMRs; however, we urge that the description of the actions taken by the applicant to address these issues be more explicit and less subjective.