News That Quotes Us & Our Work Archives

Prasad Out At FDA, Turning Critics’ Focus Back To Makary

Inside Health Policy, March 6, 2026: FDA’s biologics chief Vinay Prasad is leaving FDA for the second time. This time his rejection of Uniqure and other rare disease treatments angered industry and some rare disease patients, and Members of Congress. But NCHR’s Zuckerman says Prasad’s focus on evidence strengthened FDA and will be missed.

Divisive F.D.A. Vaccine Regulator Is Resigning

New York Times, March 6, 2026: FDA’s biologics chief Vinay Prasad is resigning, leaving FDA for the second time. This time his rejection of rare disease treatments angered industry, some rare disease patients, and Members of Congress. But NCHR’s Diana Zuckerman says Prasad’s focus on evidence was welcomed by researchers and advocates who were concerned about FDA’s approval of ineffective treatments.

FDA’s Hoeg Reportedly Trying To Hire Friend, Fellow Antidepressant Skeptic

BioSpace, March 5, 2026: FDA’s CDER Director Tracy Beth Høeg wants to hire her friend Adam Urato, whose citizen’s petition urges a boxed warning on the risks of SSRIs during pregnancy. Diana Zuckerman and others say Høeg’s work has no nuance and doesn’t want to hear differences of opinion.

Edwards’ request for broader TAVR Medicare coverage gets pushback

MedTech Dive, January 28, 2026: MedTech Dive quotes public comments to CMS for and against Medicare coverage of TAVR for asymptomatic patients, including NCHR’s and Steve Woloshin’s criticism of the published evidence and medical society support

5 topics to watch as MDUFA negotiations restart

MedTech Dive, Jan 13, 2025: MedTech outlines 5 key issues as MDUFA negotiations restart, including FDA staffing, device safety and effectiveness, and transparency. The article highlights growing concern from NCHR’s Diana Zuckerman and other patient and consumer groups that safety and effectiveness may receive less attention than faster device approvals.