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.

Comments to FDA on New Approaches to Antibacterial Drug Development

July 30, 2013. As members of the Patient, Consumer, and Public Health Coalition, we recognize the need for new drugs to reach patients with serious or life-threatening diseases. The pipeline for new antibacterial drugs is shrinking. However, we have grave concerns about proposals to change the standards for meeting FDA’s requirement of two “adequate and well controlled” trials.

NCHR Testimony at FDA Advisory Committee on Implanted Blood Access Devices

June 27, 2016. FDA wanted to change implanted blood access devices, like catheters and cannulas, from a Class III device (highest standards) to a Class II device (lower standards). Senior fellow, Jennifer Yttri, spoke on behalf of NRC about how reclassification would limit the ability of FDA and patients to request more safety and efficacy testing and remove faulty devices from market.

NCHR Testimony at FDA on Sorbent Hemoperfusion Systems

June 27, 2013. These systems are used to filter toxins out of the blood . However, there is not proof that the devices save the lives of patients who are poisoned, have a drug overdose, or are in a coma from liver failure. Because of this lack of evidence, Dr Yttri and the NRC argued that these devices need to undergo clinical testing.

NCHR Testimony at FDA Advisory Committee on Reclassification of Blood Lancets

June 26, 2013. Blood lancets, used to test blood sugar levels in diabetics or to obtain blood samples from finger pricks, have been considered a low risk medical device, like band-aids. However, FDA and CDC have found that blood lancets being used on multiple patients have resulted in increasing numbers of hepatitis outbreaks. In a statement to the FDA, NRC made the claim that blood lancets are medium and high risk devices, that require more regulation than low risk devices.

Coalition Comments on Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System

June 24, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs). However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices.