On Medical Treatments & Products Archives

Testimony of Dr. Diana Zuckerman at the FDA Oncology Drugs Advisory Committee on TRUQAP

FDA Oncology Advisory Committee on TRUQAP, April 30, 2026: NCHR president Dr. Diana Zuckerman expressed her concerns about the serious risks and uncertain benefits of TRUQAP given that there is no evidence that it improves overall survival

Testimony of Dr. Diana Zuckerman at the FDA Oncology Drugs Advisory Committee on Breast Cancer

FDA Oncology Advisory Committee, April 30, 2026: NCHR president Dr. Diana Zuckerman expressed her concerns about uncertain evidence in the SERENA-6 trial of camizestrant in patients with ER+HER2 advanced breast cancer in combination with a CDK4/6 inhibitor plus aromatase inhibitor upon detection of an ESRI biomarker.

NCHR Written Comment to AHRQ on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women

May 13, 2026, NCHR submitted comments in response to AHRQ’s request for feedback on its research protocol that will inform the NIH Pathways to Prevention Workshop on Improving the Management of Menopausal Symptoms. NCHR urged AHRQ to include all relevant studies rather than exclude foundational evidence through publication date cutoffs. We are especially concerned at the exclusion of long-term Women’s Health Initiative (WHI) findings, and to provide unbiased, easy-to-understand information about the risks and benefits of different menopause treatments.

NCHR Written Comment to FDA on Testosterone Replacement Therapy for Men

February 9, 2026 NCHR Written Comment to FDA: Testosterone hormone therapy (TRT) for men is widely promoted to men as a treatment for fatigue, weight gain, mood changes, and declining vitality. However, evidence from well-designed clinical trials shows limited benefits and raises important safety concerns. Testosterone is not a proven treatment for normal aging, and long-term risks remain insufficiently studied. Larger, long-term research is needed before FDA makes decisions about changing indication, labeling and warnings, because rigorous scientific evidence is more important than marketing claims or anecdotal experience. This is also true regarding testosterone for women.

Testimony of Dr. Akashleena Mallick at the FDA TPSAC Meeting on ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A, Inc.

January 22, 2026 NCHR Comment to FDA: Dr. Akashleena Mallek told FDA we disagree that ZYN nicotine pouches are less dangerous than smoking. ZYN has never been tested in long-term studies to determine its impact on cancer, heart disease, and other serious diseases. It is especially harmful because it is marketed to children and teen non-smokers, creating an epidemic of nicotine addiction similar to the vaping epidemic among children a few years ago.