NCHR Written Comments on the Reauthorization of PDUFA

August 14, 2025: National Center for Health Research written comment urges FDA to use PDUFA user fees to improve drug safety and effectiveness, not just faster approvals. All programs included in Commitment Letter should emphasize the scientific standards and evidence that will ensure that drugs and biologics have meaningful benefits for patients that outweigh any risks.

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NCHR Public Comment on Improving the Generic Drug User Fee Act (GDUFA IV)

National Center for Health Research’s written comment on GDUFA IV urges the FDA to use generic drug user fees to pay for staff and resources that improve generic drug safety and equivalence, not just speedy review. We point out that hundreds of generic drugs that are still for sale have been found to be contaminated, the wrong dosage, or otherwise unsafe or ineffective for patients. To regain the trust of all patients and health professionals, FDA needs to do more testing and inspections and make sure that bad drugs are recalled.

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NCHR Comment on Hernia Mesh Package Labeling Recommendations

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.
Only social media should be: X/Blueky: Why have tens of thousands of patients been harmed by mesh used in hernia repair? FDA’s proposed solution will not solve the problem of dangerous mesh complications.

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FDA Public Meeting on MDUFA VI: Invited Presentation of Dr. Diana Zuckerman

August 4, 2025: Diana Zuckerman presented on behalf of NCHR at FDA’s first public MDUFA VI meeting of 2025. She focused on device performance goals that enhance safety, effectiveness, and transparency prior to FDA approval or clearance, and evaluating safety, effectiveness, and information for patients post-market. A major focus was on user fees being used to improve the data needed for informed consent for patients, consumers, and providers.

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