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.
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.
NCHR Comments to FDA on the Draft Guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act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.
Read More »NCHR Testimony at the Meeting of the Nonprescription Drugs Advisory Committee Concerning Oral Phenylephrine (PE) as a Nasal Decongestant
September 11, 2023: Orally administered phenylephrine (or PE) as a nasal decongestant should not be on the market because it has not been shown to work. Millions of dollars have been wasted by consumers on a product that has been shown in research to act similar to a placebo.
Read More »NCHR Comments on Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
September 11, 2023, NCHR supports the FDA’s draft guidance with key recommendations. NCHR urges the FDA to add standardized protocols for instances of participant non-adherence, disease flair up, and acute illness. NCHR also recommends including specific guidance for crossover clinical trial design and more objective measures for dietary compliance rather than food diaries to strengthen the quality of the clinical trials performed among the IEM patient population, reduce confounding, and improve data interpretability.
Read More »NCHR Comments on Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination FDA Draft Guidance
September 11, 2023: Tattoos are common in the U.S. and almost half tattoo inks are contaminated. NCHR supports FDA’s draft guidance to improve the safety of tattoo ink and recommends that labels describing the links be available to consumers and sterile dilution techniques should be required and explained. NCHR urges FDA to develop an information toolkit to increase
consumer awareness about reporting any adverse reactions to tattoos.