Caroline Bradford

Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings

July 7, 2023: The Coalition expressed our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.

Alzheimer’s Drug Safety Hinges on Doctors Heeding FDA Warning

Bloomberg Law News, July 12, 2023: NCHR says the FDA black box warnings about brain swelling and bleeding and other cautions about who is most likely to be harmed by Alzheimer’s drug Leqembi will help protect patients with mild cognitive impairment, but only if their doctors pay attention and accurately discuss the risks vs. uncertain benefits with patients and family members.

No more FDA adcomm votes? Reforms brew as new research highlights decline in meetings

Endpoints News, July 7, 2023: FDA wants to revamp its Advisory Committee meetings but will they make them better or worse? The votes aren’t the problem. We explain that the conflicts of interest of committee members is “outrageous.”

NCHR Comments on FDA’s Patient-Focused Drug Development Draft Guidance

July 5, 2023: NCHR supports the FDA’s efforts to increase patient engagement in medical product development and emphasizes the need for diverse and representative samples, the importance of transparency in data analysis, and the use of COA-based endpoints in regulatory decision-making and drug labeling.

NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

June 26, 2023: In our public comment, NCHR supports the FDA’s survey on evaluating patients’ understanding of quantitative information provided in prescription drug advertising. We strongly recommend adding an assessment of comprehension for factors such as relative risk, absolute risk, relative benefit, and absolute benefit of drugs. We urge the FDA to include a diverse demographic of participants in the one-on-one interview informing the survey and provide details about the number of interviews OPDP plans to conduct.