September 9, 2019. We strongly encourage the USPSTF to delay recommendations until they obtain evidence to ensure that screening for illicit drug use does not have unintended consequences that outweigh any benefits.
Read More »On Medical Treatments & Products
NCHR Testimony on Descovy for PrEP
August 7, 2019. We understand the desire to provide a new PrEP treatment indicated for a broad population, especially when that new treatment is expected to potentially have fewer risks for kidneys and bone density. However, it is inappropriate and potentially dangerous to approve this drug for subgroups of patients that haven’t been adequately studied. The FDA law requires substantial evidence that the benefits outweigh the risks for each subpopulation that the new indication would include.
Read More »NCHR Testimony on Nintedanib for SSc-ILD
July 25, 2019. There is a critical need for new treatments for SSc-ILD. We all hope that Nintedanib [brand name OFEV] will help slow the rate of decline, but the data are not yet sufficient.
Read More »Dr. Diana Zuckerman’s Statement on FDA’s Request for Recall of Allergan Breast Implants and Expanders
July 24, 2019. When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma. This recall will reduce that risk but it won’t eliminate it.
Read More »NCHR Public Comment on Fixed-Quantity Blister Packs for IR Opioid Analgesics
July 30, 2019. To ensure that requiring the availability of blister packaging does not have unintended consequences that outweigh any benefits, we encourage the FDA to study blister packaging for outpatient IR-opioid dispensing to assess how such packaging influences prescribing and usage, and thus affects the misuse or abuse of opioids.
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