Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling

Regulatory Affairs Professional Society, August 11, 2025: This article published by the Regulatory Affairs Professionals Society provides an excellent summary of key responses to the FDA’s request for public comment on regulations for hernia mesh. It clearly shows the conflicting perspectives of the device industry and healthcare experts about patients’ need for specific information about the risks and benefits of hernia mesh.

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Medical device industry says future MDUFA hikes unsustainable

MedTech Dive, August 5, 2025: NCHR’s Diana Zuckerman and Patient, Consumer, and Public Health Coalition’s Tess Robertson-Neel are quoted in the MedTech Dive’s article about the MDUFA VI meeting at FDA in August 2025. Alex Baum of Coalition member Generation Patient is also quoted. They focused on including patient and consumer stakeholders in MDUFA negotiations and using user fees for post-market safeguards and other efforts to improve the quality of medical devices.

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F.D.A. Panel to Reassess Hormone Therapy Warnings

New York Times July 17, 2025: This FDA panel hosted by Commissioner Makary ignores evidence of the serious risks of hormone therapy for menopause, such as breast cancer, endometrial cancer, and stroke. Instead it focuses only on benefits, relying on misleading and erroneous information. The panel wants to remove the “black box” warning that tells women about the risks. No public comment was allowed at the meeting. We would have disagreed strongly, except with the issue of whether hormonal cream used in the vagina should not have the same black box warning as the hormonal pills.

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FDA Panel to Revisit Menopausal Hormone Therapy

Politico; July 15, 2025: This article describes the FDA panel on the risks and benefits of hormone therapy for menopause: breast cancer, heart disease,stroke, dementia. Zuckerman points out that the panel is one-sided, ignoring data on risks and not allowing public comments from patients or experts to ask questions or describe studies indicating cancer and other serious risks.

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