Testimony & Briefings

NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices November 18, 2019. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
NCHR Testimony on Research Needed on Immunological Responses to Metal in Implants November 13, 2019. Dr. Diana Zuckerman describes the types of research needed to reduce harm from the metal and other substances in implanted devices, including joint replacements, cardiac implants, mesh, reproductive devices, and many other types of implants.
NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning the Health Risks of Artificial Turf and Playgrounds November 18, 2019. There is a growing body of evidence of the risks of the chemicals and lead in artificial turf and rubber surface playgrounds.  It would not be ethical to intentionally expose children to these play areas, and no independent researchers or government researchers have conducted long-term studies to determine if children with greater exposures are more likely to develop the health problems that are expected, such as obesity, asthma, cognitive damage, early puberty, and eventually cancer.
Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft … Continue reading Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants
NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning Artificial Turf and Playgrounds We have been contacted by families in Rye who are concerned about the risks of artificial turf and playgrounds. We agree with them that converting grass fields to artificial turf poses unnecessary dangers to children in your community.
NCHR Comments on FDA’s Draft Guidance on Enhancing the Diversity of Clinical Trial Populations August 6, 2019. There are reasons why a drug or device may be less safe or less effective for women, children, older patients, or certain ethnic or racial subgroups.  These differences in results for under-represented subgroups may not be minor or trivial.  This is why sufficient inclusion of under-represented groups is so important.
NCHR Public Comment to FDA on breast implant safety NCHR submitted a comment to the FDA regarding the safety of breast implants, making suggestions for patient checklists, registry changes, and more.
Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing Cancer Prevention and Treatment Fund comments on USPSTF draft recommendation for BRCA related cancer risk assessment methods.
NCHR Comment on Management of Cybersecurity in Medical Devices March 18, 2019. Software and medical devices have become increasingly interconnected and vulnerable to cybersecurity breaches, which puts patients at risk. 
NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices NCHR testified on March 8th, 2019 at the Microbiology Advisory Committee urging panel members to consider increasing HPV screening age from 25 to 30.
NCHR Statement to the Maryland State House Environmental Committee, Artificial Turf NCHR’s Jack Mitchell made a statement at the Maryland State House Environmental Committee regarding artificial turf and its negative effects.
Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for Breast Cancer: Medication Use to Reduce Risk CPTF comments on the USPSTF breast cancer medications such as tamoxifen and raloxifene that are used to reduce risk in patients.
NCHR Comments on USPSTF’s Draft Research Plan for Colorectal Cancer: Screening January 30, 2019. We strongly support the USPSTF’s efforts to update recommendations for different types of colorectal cancer screening for different demographic subgroups, as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services.
Prepared Statement to the Greenwich Board of Estimate and Taxation Regarding Dangers of Artificial Turf, January 24, 2019 NCHR President Dr. Diana Zuckerman presented comments in Greenwich, CT regarding the possibility of artificial turf being used in their schools and fields.
NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance December 13, 2018. The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.
NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.
NCHR Testimony to the FDA Patient Engagement Advisory Committee on Medical Devices November 15, 2019. NCHR testified to the FDA regarding social media surrounding medical devices, and how it affects patient engagement.
NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.
NCHR Testimony on the Opioid Sufentanil NCHR testifies against the approval of Sufentanil, a new sublingual opioid 10-15 times more potent than fentanyl.
NCHR Testimony of TIRF REMS August 3, 2018. TIRFs provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks.  These REMS are not working as well as the should to protect patients and need to be approved.