September 13, 2019. This is the first treatment for peanut allergies and if this drug is approved despite the unanswered questions, it will set a precedent for future drugs to treat food allergies. It is especially important that new classes of products provide strong evidence of safety and efficacy before approval, because it will be difficult if not impossible to obtain it afterwards.
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NCHR Comment on FDA’s Draft Guidance to Industry on Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy
September 10, 2019. We strongly urge the FDA to convey to industry the need for a comparison group instead of historical controls, the need to conduct subgroup analyses of the safety and efficacy of hormonal contraceptives for each of several major patient populations, and the importance of premarket studies that quantify the likelihood of adverse events for different subpopulations.
Read More »NCHR Comment on USPSTF Draft Recommendation on Illicit Drugs Use Screening
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 »NCHR Testimony on Descovy for PrEP
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have […]
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.
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