October 11, 2024: We presented our public comment at the NASEM Review of CDC COVID-19 Vaccine Safety Research and Communications Meeting 3 on how CDC could improve research and communications regarding COVID-19 vaccines. We said CDC needs to be clear on what is known and not known and needs to quantify what is known about adverse events and complications from vaccines.
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 Public Comment on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies
September 26, 2024: NCHR appreciates the improvements made in the 2024 FDA draft guidance for Diversity Action Plans but the draft lacks incentives to encourage companies to comply. The indication and label should reflect the evidence for sex, race, ethnicity, and ages of patients studied. Approval should only be for patients for whom clear evidence of safety and effectiveness was provided.
Read More »Testimony of Diana Zuckerman at the FDA Gastrointestinal Drugs Advisory Committee Meeting on Ocaliva
September 13, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that the data presented on Ocaliva for a rare liver disease does not meet the FDA’s standard of evidence to keep it on the market and that the results do not prove that OCA prevents death or prevents the need for a liver transplant.
Read More »Testimony of Diana Zuckerman at the FDA Antimicrobial Drugs Advisory Committee Meeting on Sulopenem
September 9, 2024: NCHR’s Dr. Diana Zuckerman tells FDA Advisory Committee that sulopenem antibiotic is not proven to benefit patients with uncomplicated UTI compared to amoxicillin or Cipro. It should be evaluated in terms of alleviating symptoms, not in terms of bacteria in the urine, and definitely should not be considered a first line treatment.
Read More »Testimony of Grace Drew at the FDA Advisory Committee Meeting on Imfinzi for Resectable Non-Small Cell Lung Cancer
July 25, 2024: At the FDA Advisory Committee meeting on a new indication for Imfinzi (durvalumab), NCHR pointed out that the AEGEAN clinical trial did not assess if Imfinzi is necessary both before and after lung tumor surgery. We strongly support the FDA scientists who stated that the trials need to be redesigned to determine whether Imfinzi both before and after surgery is more beneficial compared to Imfinzi either before or after surgery.
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