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.

Letter from the Patient, Consumer and Public Health Coalition to Dr. Margaret Hamburg on the De Novo Process and High-Risk Medical Devices

February 28, 2012. In this letter to the FDA Commissioner, the Patient, Consumer, and Public Health Coalition expresses their concerns over the de novo approval process for high-risk medical devices, specifically a endovascular suturing system.

NCHR Testimony on Classification for Cranial Electrotherapy Stimulators

February 10, 2012. This testimony supported the FDA’s position that the available scientific evidence does not support reclassifying Cranial Electrotherapy Stimulators to a medical device category with lower risk.

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.

Letter to Dr. Margaret Hamburg, FDA Commissioner, Regarding Maintaining and Strengthening Conflict of Interest Policies for Advisory Committees

August 3, 2011. In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases.

FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data About Quality of Life, Connective Tissue Symptoms, Rupture Rates Per Patient, and Other Complications

January 5, 2012. At the FDA Advisory Panel meetings in 2003 and 2005, FDA provided and presented data from the Breast Implant Core studies regarding connective tissue disorder (CTD) signs and symptoms (S/S) and Quality of Life measures.