December 10, 2012. Dr. Yttri tesifies to the FDA that the clinical utility of the NeuroFlo device for the SENTIS subject population should be carefully assessed, considering both the lack of benefits and increased risks with an unnecessary procedure.
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 Testimony to FDA Advisory Committee on Bedaquiline
November 28, 2012. Dr. Yttri testifies to the FDA Committee that the data on bedaquiline indicate that the benefit to patients with multi drug resistant tuberculosis is questionable. The FDA’s responsibility is to approve drugs that will help, not harm, consumers. Treatments exist for patients with multi drug resistant tuberculosis that are safer without the addition of bedaquiline.
Read More »Testimony to FDA Advisory Committee on Intra-Aortic Balloon Pumps
December 5, 2012. We strongly agree with the FDA that IABP devices used to treat septic shock and Intraoperative Pulsatile Flow Generation should remain Class III, with PMAs required. The evidence of safety and effectiveness for these indications has yet to be established.
Read More »Testimony to FDA Advisory Committee on External Counter-Pulsating (ECP) Devices
December 5, 2012. We do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses.
Read More »Statement of Dr. Diana Zuckerman, Capitol Hill Press Conference for VALID Compounding Act
November 14, 2012. The VALID Compounding Act would save lives by closing loopholes in the law.
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