Why are there tens of thousands of reports to FDA of patients harmed by mesh used in hernia repair? NCHR points out that the FDA proposed guidance is unlikely to reduce that harm because it does not point out the many serious risks of mesh. We tell the FDA that mesh labeling should have warnings about frequency of the many adverse events of specific mesh products, and FDA should require research to determine which products are safer and which are more dangerous, and for which patients.
Read More »Author: Caroline Bradford
Inside Health Policy: Prasad Leaves FDA After Sarepta Furor, Conservative Backlash
Inside Health Policy, July 29, 2025: Vinay Prasad leaves his key post at the FDA after a conservative backlash from Laura Loomer and WSJ. Sarepta’s gene therapy Elevidys has killed 2 patients so Prasad’s concerns were appropriate and the opposition is not focused on the evidence. We point out that FDA must require better evidence that Elevidys is safe & effective and should limit access meanwhile in order to restore trust in the FDA and the gene therapy.
Read More »FDA ‘Expert Panels’ Raise Concerns of Evading Regulations, Ethics: Do panels cherry pick experts and evidence that align with FDA leadership’s views?
July 24, 2024 MedPage explains how FDA’s new meetings are called expert panels but their “experts” seem to have one thing in common: they agree on one side of controversial issues, such as the safety of hormone therapy despite reported cancer risks, the risks of talc for cancer, and the risks of SSRIs (depression drugs). We tell MedPage that the meeting rooms are small and filled primarily with supporters and no public questions or comments are allowed. The meetings are not announced to the general public and usually only a few days in advance. We explain all the reasons why this is the opposite of the transparency we were promised by HHS.
Read More »NCHR Comment at FDA Advisory Committee on Rexulti Used with Zoloft
July 18, 2025: We testify at FDA Advisory Committee about the lack of evidence that Rexulti combined with Zoloft treats PTSD better than Zoloft alone. Rexulti wants approval for PTSD to sell more product but it doesn’t seem to work, and its side effects include suicidal thoughts and behaviors, weight gain, diarrhea, anxiety, uncontrolled body movements, diabetes, compulsive behaviors, and stroke.
Read More »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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