April 29, 2021: Patients are being harmed when the FDA does not follow the law pertaining to FDA approval. Drugs must be proven safe and effective, and companies must continue randomized clinical trials that prove the benefits of their drugs outweigh the risks for most patients.
Read More »On Medical Treatments & Products
NCHR Statement at FDA Advisory Committee Meeting on Tecentriq for Triple Negative Breast Cancer
April 27, 2021: A new randomized controlled trial that includes more Black women is needed to evaluate Tecentriq for Triple Negative Breast Cancer in order to keep FDA approval. The FDA doesn’t do patients any favors by continuing to approve a treatment that isn’t shown to help and may actually harm them.
Read More »NCHR’s Testimony at FDA Regarding Donislecel Treatments for Diabetes
April 15, 2021: We agree with the concerns of the FDA reviewers regarding the benefit-risk profile of donislecel transplant treatments.
Read More »NCHR’s testimony to FDA on the OCS Heart System
April 6, 2021. The materials presented have not proven that the OSC Heart System is as effective or more effective than the usual standard of care.
Read More »NCHR’s Comments to USPSTF on Aspirin to Prevent Morbidity and Mortality from Preeclampsia
March 22, 2021: We support this update, strengthened by new evidence, maintaining the 2014 “B” recommendation that there is moderate certainty of a substantial net benefit for the use of low-dose aspirin as preventive medication after 12 weeks of gestation in women who are at high risk for preeclampsia.
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