December 26, 2023: We responded to the FDA’s request for public comment about the scientific information (SIUU) that firms can provide to healthcare providers about the unapproved uses of approved medical products. Promotion for unapproved (off label) uses were prohibited years ago, but that has been loosened over the decades and the FDA’s new draft guidance is worrisome because it is not as specific as it should be about how to ensure that the information the companies provide is accurate and not misleading. We agree with some of the guidance but urge more careful wording to ban the use of poor quality data and misinterpretation.
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NCHR Comments On FDA’s Draft Guidance Regarding the Confirmatory Evidence Needed to Demonstrate A Drug’s Effectiveness
December 18, 2023: NCHR urged the FDA to institute stronger scientific standards to confirm that a new drug is effective, preferably two randomized, double-blind, clinical control trials. Patients deserve drugs that are proven to work, not drugs that possibly work.
Read More »NCHR Comments On the FDA’s Draft Guidance Regarding the Development of Novel Drugs for Diabetic Foot Infections
December 18, 2023: NCHR urges the FDA to oppose using non-inferiority trials as evidence for new antibiotic treatments for diabetic foot infections. FDA defines “non-inferior” to include “slightly worse” but new antibiotic treatments should be better than standard treatments. Otherwise they don’t benefit patients and worsen antimicrobial resistance.
Read More »Patient, Consumer, and Public Health Coalition Letter to Senator Braun Regarding the Promising Pathways Act
NCHR and the Patient, Consumer, and Public Health Coalition oppose the Promising Pathways Act, which would allow FDA to approve drugs that aren’t proven to work and then to remain on market for up to 8 years without proof of effectiveness. The bill is supposed to help provide treatment for the most serious diseases, but is poorly written, providing false hope, huge financial burdens for patients and Medicare, and undermining existing FDA pathways that are more targeted to urgently needed treatments.
Read More »Public Comment of the National Center for Health Research on USDA Proposed Rule on New Program on Natural Grass and Sod Products, Docket AMS-LP-21-0028
December 15, 2023: In response to a request for public comment, NCHR submitted a comment in support of the USDA proposed rule to establish a promotion, research, and information program for natural grass sod products. We believe this will provide important information that will help reduce the proliferation of artificial turf, which endangers the health of children and adults as well as harming the environment.
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