National Center for Health Research

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The National Center for Health Research is a nonprofit, nonpartisan organization that is dedicated to improving the lives of adults and children.

NCHR's Dr. Diana Zuckerman told the FDA that MDUFA V had more than 200 demands on . Who is regulating who? MDUFA VI sh...
08/04/2025

NCHR's Dr. Diana Zuckerman told the FDA that MDUFA V had more than 200 demands on . Who is regulating who? MDUFA VI should require device companies to provide funds for FDA staff who focus on thorough reviews that provide evidence of safety and effectiveness, patients' informed consent, and better post-market surveillance of ads and quality of devices. Read her comment here:

Diana Zuckerman of NCHR presented at FDA 1st public MDUFA VI meeting of 2025, about device performance goals that enhance safety, effectiveness, transparency

Dr. Vinay Prasad left his key post at the FDA after a conservative backlash from Laura Loomer and Wall Street Journal. S...
07/30/2025

Dr. Vinay Prasad left his key post at the FDA after a conservative backlash from Laura Loomer and Wall Street Journal. Sarepta's gene therapy Elevidys costs $3.2 million per patient, has killed 2 teenagers and isn't proven to delay or reverse symptoms of Duchenne muscular dystrophy. Prasad's decision to pause sales were appropriate, so why is he gone? The opposition to Prasad shows how political FDA has become, since it was not based on his scientific expertise. We point out that FDA must now require better evidence that Elevidys is safe and effective and should limit access meanwhile in order to restore trust in the FDA and the gene therapy.

Top FDA official Vinay Prasad abruptly resigned late Tuesday just months after joining the agency and being rapidly promoted to an unprecedented role as chief medical and scientific officer in addition to biologics chief. The departure, coming after a flip flop Monday by FDA to resume availability o...

Is your state doing enough to protect you and the environment from ? This report by the Ocean Conservancy looks at stat...
07/25/2025

Is your state doing enough to protect you and the environment from ? This report by the Ocean Conservancy looks at state and local laws and ranks states from best to worst. The report’s authors made it clear that all states need to do more to combat plastic waste and pollution, but some are doing more than others. Plastic pollution affects all of us, so see how your state measures up and ask your legislators to do more!

The first-of-its-kind report graded states based on an analysis of local laws. See where your state ranks.

80 years ago this month, the U.S. government detonated the first atomic bomb in the in New Mexico. The of this explo...
07/25/2025

80 years ago this month, the U.S. government detonated the first atomic bomb in the in New Mexico. The of this explosion spread all the way to New York, and radiation levels reached up to 10,000 times maximum limits in some surrounding New Mexico counties. The fallout didn’t just poison the land; it also poisoned many adults and children, including 12 young girls at a summer camp nearby who played in the falling ash, which looked like snow. They all developed cancer and were among the first civilian victims of nuclear testing. The cover-ups lasted decades.

The Trinity nuclear test was not conducted on barren, uninhabited land.

We tell MedPage how FDA's new meetings are called expert panels but their "experts" seem to have one thing in common: th...
07/25/2025

We tell MedPage 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). 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.

FDA expert panel members with financial conflicts widely share biased opinions on HRT, talc, SSRIs, infant formula. No public questions or comments allowed.

The FDA is using a new AI tool called Elsa to help speed up drug reviews and food safety alerts. While leaders at the ag...
07/24/2025

The FDA is using a new AI tool called Elsa to help speed up drug reviews and food safety alerts. While leaders at the agency say it’s a big step forward, some staff are raising red flags. They say Elsa sometimes gives wrong information or even makes up studies. Experts outside the FDA are also worried the agency is moving too fast without enough checks. Everyone agrees AI can help, but only if it’s done safely and with care.

FDA's AI tool, Elsa, faces scrutiny for producing unreliable data, raising concerns about its rapid implementation and impact on regulatory accuracy.

We testified at an FDA Advisory Committee on July 18 about the lack of evidence that Rexulti combined with Zoloft treats...
07/21/2025

We testified at an FDA Advisory Committee on July 18 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. Fortunately, the Advisory Committee agreed with us and voted 10-1 against Rexulti for PTSD. The only vote in favor was the patient representative, who said patients need options and seemed unconcerned about the risks.

Diana Zuckerman of NCHR testifies at FDA Advisory Committee about lack of evidence that Rexulti combined with Zoloft treats PTSD better than Zoloft alone

Infant Safety Warning: A recent study says nursing pillow misuse may be causing 5% of Sudden Unexpected Infant Death Syn...
07/18/2025

Infant Safety Warning: A recent study says nursing pillow misuse may be causing 5% of Sudden Unexpected Infant Death Syndrome cases. . (This includes SIDS as well as other sudden infant deaths). Nursing pillows are only meant for comfort and support while the baby is nursing, and should NOT be near a sleeping baby. New Consumer Product Safety Commission standards require informing caretakers of the danger of nursing pillows near sleeping infants. Other pillows and blankets already have these warnings, but older products may lack them. saves lives. Read:

Blankets and pillows are cited as a risk factor for sudden unexpected infant deaths (SUIDs), an umbrella term that includes sudden infant death syndrome (SIDS)—whose cause is still unknown—as well as other accidental bed-related deaths. Although the Consumer Product Safety Commission (CPSC)...

I just left this meeting on therapy for . It ignored the of cancer, cancer, and , and included erroneous and...
07/17/2025

I just left this meeting on therapy for . It ignored the of cancer, cancer, and , and included erroneous and misleading information that would make you think hormones are the fountain of youth! And as ! predicted, there was no opportunity for the audience to ask questions or make comments. But what we didn't know, is that the small room would be filled with friends and patients of the panel members, and then the FDA told people who tried to register to attend in person that the seats were all filled.

Dr. Marty Makary, commissioner of the Food and Drug Administration, will convene an expert panel Thursday that he said will “set the record straight” about

describes the upcoming panel on the risks and benefits of therapy for menopause: cancer, heart disease, , . NCH...
07/15/2025

describes the upcoming panel on the risks and benefits of therapy for menopause: cancer, heart disease, , . NCHR's Diana 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 increases in and other serious risks.

Politico describes the FDA panel on the risks and benefits of hormone therapy for menopause: breast cancer, heart disease, stroke, dementia. Why so biased?

NCHR presentation at GDUFA IV July 2025 generics user fee meeting focuses on including patients and consumers in negotia...
07/11/2025

NCHR presentation at GDUFA IV July 2025 generics user fee meeting focuses on including patients and consumers in negotiations with FDA and industry and a Commitment Letter that includes metrics to show improved safety and equivalence for generic drugs.

Zuckerman NCHR talk at GDUFA July 2025 generics meeting focuses on including patients and consumers and metrics showing improved safety and equivalence

Nearly 368,000 pounds of Oscar Mayer fully cooked turkey bacon are being recalled due to possible listeria contamination...
07/11/2025

Nearly 368,000 pounds of Oscar Mayer fully cooked turkey bacon are being recalled due to possible listeria contamination. No illnesses have been reported yet, but listeria can cause serious health risks, especially during pregnancy and for older adults and those with weakened immune systems. Check for products with use-by dates July 18-Sept 4 and lot codes RS19, RS40, or RS42.

(AP) — Nearly 368,000 pounds of Oscar Mayer turkey bacon products are being recalled over possible contamination with listeria bacteria that can cause food poisoning, federal health officials said Wednesday. No illnesses have been confirmed to date, U.S. agriculture department officials said. Kraf...

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