November 7, 2024: We testified at an FDA Advisory Panel meeting to advise FDA whether ProSense Cryoablation can replace lumpectomy for older women with very early, low-risk breast cancer. This technique can freeze and destroy a tumor in a few minutes but the research was not well-designed to determine if it is as safe as lumpectomy, and if so, for which types of patients.
Read More »On Medical Treatments & Products
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.
Read More »Patient, Consumer, and Public Health Coalition Public Comment to CMS on Transcatheter Tricuspid Valve Replacement Coverage
July 19, 2024: FDA approval of TTVR was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. The Patient, Consumer, and Public Health Coalition urges CMS to conduct a thorough MEDCAC review prior to making a coverage decision.
Read More »