February 10, 2014. As members of the Patient, Consumer, and Public Health Coalition, we are pleased to have the opportunity to strongly support the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985).
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.
Letter to Congresswoman Rosa DeLauro in Support of Strengthening FDA Safeguards
February 6, 2014. We are writing to thank Representative Rosa DeLauro for her dedication to patients and consumers and work to strengthen safeguards for all medical products sold in the United States.
Read More »Patient, Consumer, and Public Health Coalition Comments on FDA Draft Guidance on Pharmacy Compounding of Human Drug Products
February 6, 2014. As members of the Patient, Consumer, and Public Health Coalition, we conditionally support the draft guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (FD&C) because it clarifies FDA enforcement actions that can be taken against individuals or firms that illegally make drugs under the banner of traditional compounding.
Read More »NCHR Testimony to the FDA Advisory Committee Regarding Dapagliflozin (Farxiga)
December 12, 2013. NCHR expresses concerns about this drug that there are just too many unanswered questions – and those unanswered questions are frightening ones.
Read More »NCHR Testimony on Telavancin (VIBATIV) to FDA
November 29, 2012. Dr. Yttri testifies to the FDA that there is not sufficient evidence to support telavancin as a safe and effective treatment for nosocomial pneumonia. The data raise questions about a high mortality rate associated with telavancin.
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